BIOTECHTRADER

THLD Q3 update

2011-11-03T19:14:00.000-04:00

Cash - Q3 of 2012

1 Report top line results from the Phase 1 clinical trial in advanced
leukemias by the end of 2011,

2 Report top line efficacy analysis results from the randomized Phase 2
trial in pancreatic cancer around the end of 2011,

3 Provide an update on the interim analysis from the pivotal Phase 3
clinical trial of TH-302 plus doxorubicin compared to doxorubicin
alone in patients with metastatic or locally advanced unresectable
soft tissue sarcoma around the end of 2012.

$ADLR Announces Positive Results from Phase 2 Program in OIC

2011-08-10T09:05:00.000-04:00

EXTON, Pa., Aug 10, 2011 (BUSINESS WIRE)

Adolor Corporation (nasdaqgm:ADLR) today announced positive, statistically significant top line results from its two Phase 2 studies of ADL5945 in chronic non-cancer pain patients with opioid-induced constipation (OIC). ADL5945, a peripherally-acting mu opioid receptor antagonist, is an investigational drug being evaluated for the treatment of OIC as well as other associated gastrointestinal (GI) complications. Both randomized, double-blind, placebo-controlled studies were identical in design; Study 242 evaluated 0.25 mg and 0.10 mg of ADL5945 administered twice daily (BID) and Study 243 evaluated 0.25 mg of ADL5945 administered once daily (QD).
"Opioid analgesics have become a cornerstone of multimodal therapy for the management of patients who suffer with chronic non-cancer pain," said Neil Singla, M.D., Department of Anesthesiology, Director, Clinical Research, Huntington Memorial Hospital in Pasadena, California, and lead investigator for the Phase 2 program. "Unfortunately, OIC presents a very serious burden to most patients treated on long-term opioid therapy, and currently there are no adequate therapies to address this common and debilitating condition. The results of these studies of ADL5945 are very encouraging -- demonstrating both clinically meaningful effects and a favorable tolerability profile."
"Our Phase 2 program achieved all of our objectives and validates our view that ADL5945 is a potentially important drug for patients suffering from OIC and related GI symptoms," said Michael R. Dougherty, Adolor's President and CEO. "Adolor has extensive experience in this therapeutic area that we will continue to leverage as we now focus on the Phase 3 program. There has been significant interest in ADL5945 and we look forward to sharing these data and initiating pivotal studies as expeditiously as possible."
Study Results
Twice-daily Dosing (Study 242)
Statistical significance (p = 0.0003) was achieved for the primary endpoint in the 0.25 mg BID dose group. The primary endpoint of both studies was the change from baseline in the weekly average number of spontaneous bowel movements (SBMs). Response to treatment was dose dependent in Study 242, with an average change from baseline in SBM frequency over the 4-week treatment period of 1.4 SBMs for the placebo group, and 2.0 and 3.4 SBMs for the 0.10 mg and 0.25 mg doses of ADL5945, respectively. Statistical significance was not achieved for the 0.10 mg dose.
Statistical significance (p = 0.005) also was achieved in the 0.25 mg BID dose group for a key secondary endpoint, a responders analysis, with a 56% response rate for the active arm and a 26% response rate for the placebo arm of the study. This translates into a clinically relevant number needed to treat (NNT) of 3.3. For this analysis, responders were defined as those patients who achieved an average weekly frequency of at least three SBMs and an increase of at least one SBM above baseline.
Other exploratory endpoints (patients' global impression of change, BM comfort and satisfaction scores) demonstrated greater improvement as compared to baseline in the ADL5945 0.25 mg treatment group as compared to placebo.
Once-daily Dosing (Study 243)
In Study 243, statistical significance (p= 0.01) also was achieved for the primary endpoint. The average change from baseline in SBM frequency over the 4-week treatment period was 1.4 SBMs for the placebo group and 2.6 SBMs for the 0.25 mg ADL5945 treatment group.
Although the proportion of responders was higher in the 0.25 mg treatment group (42.5% vs. 29.3% in placebo), statistical significance was not achieved.
Other exploratory endpoints evaluating changes in bowel function trended in favor of ADL5945 as compared to placebo.
Safety and Tolerability
ADL5945 was well tolerated in both studies. The overall number of patients reporting at least one treatment-emergent adverse event was comparable across both studies (adl5945:29%)(placebo:26%). There was no evidence of drug-related central opioid withdrawal or reversal of analgesia in any of the ADL5945 treatment groups across both studies.
Additional information concerning the efficacy and safety results from Study 242 and Study 243 is included in the slide presentation that will accompany the investor conference call.

$ANX Receives Complete Response Letter for Exelbine NDA - Yahoo! Finance

2011-08-09T21:49:00.000-04:00

SAN DIEGO, Aug. 9, 2011 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that it received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the Company's New Drug Application (NDA) for Exelbine™ (vinorelbine injectable emulsion) for the treatment of non-small cell lung cancer.

The FDA determined that it could not approve the Exelbine NDA in its present form. In particular, the complete response letter noted that, based on inspections at clinical sites, the authenticity of the drug products used in the pivotal bioequivalence trial (Study 530-01) could not be verified, which placed the results of the trial into question. The letter stated that the bioequivalence trial will need to be repeated to address this deficiency.

In addition, the FDA requested information regarding product quality, or CMC matters. All CMC information requests in the complete response letter were the subject of FDA inquiries from earlier in the review cycle, and the Company had submitted responses to each request prior to receipt of the complete response letter.

"We are disappointed with the FDA's determination and, next week, plan to request a type A meeting to discuss its response. Following that meeting, we will be in a better position to comment on the future of our Exelbine program. However, we believe the authenticity of the drug products used in the pivotal study is verifiable and plan to discuss FDA's concerns in this regard. We also will inquire whether FDA has comments to our previously submitted responses," said Brian M. Culley, Chief Executive Officer of ADVENTRX.

"In the meantime, our resources and focus are on ANX-188 and ANX-514, which we believe are the long-term value drivers for our company. Our cash and equivalents of $40.7 million at July 31, plus cost savings from delaying or potentially discontinuing the Exelbine program, will provide us the capital to continue to advance both of these programs," Mr. Culley added.

The Company believes that FDA's concern over drug product authenticity stems from the procedures used to select testing and reserve samples in Study 530-01 and the availability of testing and reserve samples for inspection. The Company believes the procedures used to select testing and reserve samples in Study 530-01 were adequate to verify the authenticity of the drug products. Of note, Exelbine and the reference product come in different package presentations, require different preparation procedures and have different physical characteristics. Based on the different characteristics between the study drugs, the Company believes it is unlikely that study sites would confuse the two study drugs or fail to recognize which drug was being administered to a patient.

ADVENTRX Receives Complete Response Letter for Exelbine NDA - Yahoo! Finance

$DSCO on tractk to file CR in Q3 with FDA on Surfaxin.

2011-08-03T09:21:00.000-04:00

http://www.marketwatch.com/story/discovery-labs-reports-second-quarter-financial-results-and-provides-an-update-on-lead-pipeline-programs-2011-08-03?reflink=MW_news_stmp

$ARNA -Eisai Diet Drug Less Concentrated In Human Brain Than Rat

2011-08-02T08:01:00.000-04:00

Arena Pharmaceuticals Inc. (ARNA) and Eisai Co. (ESALY, 4523.TO) said that a study of the diet pill lorcaserin showed that the drug seems to concentrate in the human brain less than it does in rats.
The data is part of the companies' work to respond to Food and Drug Administration concerns that led to the pill being rejected for approval last year. The agency requested multiple sets of new data including studies related to breast cancer and brain cancer occurring in rats, and more information on heart-related risk.
The company said that the effort to address other FDA concerns is ongoing.
Arena conducted the study by measuring lorcaserin concentrations in human cerebrospinal fluid and then seeing how that compared to the amount of the drug in blood plasma.
The company used an "apparent consistent relationship" of the amount of lorcaserin in the brain in relation to the spinal fluid of mice, rats and monkeys. That ratio was used to predict the corresponding amount of the drug in the human brain using the spinal fluid measurements.
Using the new data and previous information, Arena estimates that human brain exposure to the drug is 1.7 times the plasma concentration at normal dose. In rats with a much higher dose, but which didn't have brain cancer, the ratio was 24 times.
Arena noted that its estimates in the study are based on "certain assumptions and extrapolations" and the FDA may have different findings when looking at the raw data. The agency also may not view the company estimates as "reliable or predictive of the safety margin," Arena said in a statement.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com

$CRIS Reports Q2 2011 Financial Results

2011-07-28T08:05:00.000-04:00

Recent Developments

-- Genentech presented positive data of vismodegib pivotal clinical trial in advanced basal cell carcinoma (BCC)

In June, Curis’ collaborator Genentech, a member of the Roche group, presented detailed results from its pivotal Phase II clinical trial of vismodegib (GDC-0449, RG3616) in advanced basal cell carcinoma patients at the Seventh European Association of Dermato-Oncology (EADO) Congress in Nantes, France.

The pivotal study (ERIVANCE BCC) is an international, single-arm, multicenter, two-cohort, open-label Phase II study that enrolled 104 patients with advanced BCC, including locally advanced BCC (71) and metastatic BCC (33). The overall response rate in the pivotal Phase II trial as assessed by an independent review facility showed that vismodegib substantially shrank tumors or healed visible lesions, with observed response rates of 43% of patients in the locally advanced BCC cohort and 30% of patients in the metastatic BCC cohort. In the pivotal Phase II trial, study investigators assessed the overall response rate to be 55%, with 60% in the locally advanced BCC cohort, and 46% in the metastatic BCC cohort. The clinical benefit rate (defined as patients who experienced response as well as those who experienced prolonged stable disease for more than 24 weeks) showed vismodegib shrank tumors or healed visible lesions, or prevented them from growing any further in 75% of patients with locally advanced BCC and 76% of patients with metastatic BCC, as assessed by independent review.

The median duration of progression-free survival (PFS) by independent review for both metastatic and locally advanced BCC patients was 9.5 months. The median duration of response by independent review was 7.6 months for both metastatic and locally advanced BCC patients. The median duration of response as assessed by study investigators was 12.9 and 7.6 months for metastatic and locally advanced BCC patients, respectively.

The most common adverse events observed in the study (observed in greater than 20% of patients) included muscle spasms, hair loss, altered taste sensation, weight loss, fatigue, nausea, decreased appetite and diarrhea. Serious adverse events (SAEs) were observed in 26 patients (25%). Four of these patients (4%) had SAEs that were considered to be related to vismodegib, including one case each of: blocked bile flow from the liver (cholestasis), dehydration with loss of consciousness (syncope), pneumonia accompanied by an inability of the heart to pump enough blood (cardiac failure) and a sudden arterial blockage in the lung (pulmonary embolism). Fatal events were reported in seven patients (7%); none were considered by investigators to be related to vismodegib. In all fatalities, pre-existing risk factors and comorbid conditions were present.

Based on the results of this study, Roche has indicated that it anticipates filing an NDA with the FDA in 2011 to seek approval to commercialize vismodegib in the U.S. The filing timeline for a European regulatory submission seeking to commercialize the drug in Europe is dependent on planned discussions with the European Medicines Agency (EMA). Curis is eligible to receive milestone payments for the U.S. and European territories, assuming that submissions are filed by Roche and accepted by the applicable regulatory agencies, and Curis is also eligible for milestone payments upon regulatory approval and royalties on any future sales of vismodegib.

-- Independent-study investigator presented promising interim results from investigator-initiated Phase II study of vismodegib; data shows effect in prevention and treatment of BCC in Basal Cell Nevus Syndrome (BCNS) patients

In April, interim Phase II clinical data on vismodegib were presented at the 2011 Annual Meeting of the American Association for Cancer Research (AACR) in patients with BCNS, which is also commonly referred to as Gorlin syndrome. Vismodegib reduced the rate of new BCCs from an average of 1.74 BCCs per month in the placebo group to 0.07 in the vismodegib group (p=<0.0001) in this study. Vismodegib also reduced the size of existing BCCs (-24 cm vs. 3 cm placebo, cumulative diameter, p=0.006). Some patients achieved near-complete remission with no BCC developing resistance during this period of time on trial. Importantly, these data demonstrate proof-of-concept for the therapeutic utility of vismodegib for BCC in Gorlin syndrome patients, for whom there is no approved pharmacological standard of care intervention.Common observations related to vismodegib's safety included grade 1-2 taste loss, muscle cramps; hair loss and weight loss. There were two grade 3-4 adverse events observed, including one grade 3 muscle cramp and one grade 4 depression. Overall, 28% of patients taking vismodegib discontinued participation due to adverse events.-- Highlighted breadth of targeted cancer platform with data presentations at AACRIn April, Curis scientists delivered three poster presentations at the 2011 AACR Annual Meeting, highlighting the breadth of the Company’s targeted cancer portfolio, including presentations on Curis-discovered molecules CUDC-101, CUDC-907 and Debio 0932. Curis Reports Second Quarter 2011 Financial Results | Business Wire

$ALXA AZ-004 NDA Resubmission Now Planned for August 8, 2011 Conference Call Scheduled for 4:30 p.m. Eastern Time, August 8, 2011

2011-07-26T20:46:00.000-04:00

MOUNTAIN VIEW, Calif., July 26, 2011 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq:ALXA - News) announced today that it will report financial results for the quarter ended June 30, 2011, on Monday, August 8, 2011, following the close of the U.S. financial markets. Alexza also announced that the resubmission of its AZ-004 New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) is now planned for Monday, August 8, 2011. The Company completed the writing of the NDA sections earlier this week. The documents have been transferred to Alexza's electronic submission vendor who is assembling and processing the files for eCTD (electronic Common Technical Document) submission to the FDA.

"The entire Alexza organization has worked diligently toward the resubmission of our AZ-004 NDA," said Thomas B. King, Alexza President and CEO. "Our employees have combined their skills with those of some outstanding outside consultants and advisors, who are experts in the key areas of focus of our resubmission. In addition to the data in our original NDA, our resubmitted NDA contains data from our successfully completed human factors study, stability data from new production batches manufactured late last year, and a comprehensive REMS proposal and draft labeling for AZ-004."

On Monday, August 8, at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time, the Company will host an investor conference call and live webcast to provide a company update, as well as to discuss the financial results. The conference call, live webcast and archived replay are open to all interested parties.

$RPTP Meets Primary Endpoint in Its Phase 3 Clinical Trial of DR Cysteamine for Nephropathic Cystinosis

2011-07-25T07:56:00.000-04:00

NOVATO, Calif., Jul 25, 2011 (GlobeNewswire via COMTEX) -- Raptor Pharmaceutical Corp. ("Raptor" or the "Company") RPTP +3.57% today announced that its Phase 3 clinical trial of Delayed Release or DR Cysteamine, known as study drug RP103 ("RP103"), for the treatment of nephropathic cystinosis, met the primary endpoint of non-inferiority compared to Cystagon(R), immediate-release cysteamine bitartrate. The comparison was based on white blood cell ("WBC") cystine levels, the established efficacy surrogate biomarker and sole primary endpoint in the clinical trial. The Company also reported that there were no unexpected serious safety concerns experienced by patients in the trial attributable to RP103.

Nephropathic cystinosis is a severe ultra-orphan inherited condition which results in premature death if not treated. The current standard of care for cystinosis is oral Cystagon(R), immediate-release cysteamine bitartrate, which must be taken strictly every 6 hours, including a middle-of-the-night dose. Lack of compliance with the strict dosing schedule of Cystagon(R) has been widely reported to be a significant challenge in the therapeutic management of cystinosis patients. RP103 is Raptor's proprietary, twice-daily formulation of cysteamine bitartrate, designed for reduced dose frequency and improved tolerability for the treatment of cystinosis. Raptor's pivotal Phase 3 clinical trial was designed as an outpatient study of the pharmacodynamics, pharmacokinetics, safety and tolerability of RP103 compared to Cystagon(R) in cystinosis patients. The clinical trial was conducted at eight clinical research centers in the US and Europe.

Of 41 patients who completed the Phase 3 protocol, 38 were included in the evaluable data set, 3 not being fully compliant with the protocol. The age range of study participants was 6-26 years, with 87% of patients below 16 years old. On average, the peak WBC cystine level measured in patients treated with Cystagon(R) was 0.54 +/- 0.05 nmol 1/2 cystine/mg protein, compared to an average peak value of 0.62 +/- 0.05 nmol 1/2 cystine/mg protein for patients treated with RP103. The mean difference was 0.08 nmol 1/2 cystine/mg protein, with a 95.8% confidence interval of 0.00-0.16 (one sided p=0.021). As stipulated in the Statistical Analysis Plan, the non-inferiority endpoint of the clinical trial would be achieved when the upper end of the confidence interval around the mean difference of WBC cystine levels did not exceed an absolute value of 0.3. The upper end of the confidence interval in the Phase 3 clinical trial was determined to be 0.16, thus achieving the non-inferiority endpoint. More:

Summary of DVAX ph3 PR

2011-07-20T08:49:00.000-04:00

The bolded section is not good.. thus the selloff

"With respect to the consistency analysis of three consecutively manufactured lots of HEPLISAV, Dynavax concluded that the study had demonstrated consistency based on the complete immunogenicity data demonstrated by the three vaccine lots over the six months following second immunization.

By Geometric Mean Antibody Concentration (GMC), the results met the pre-specified consistency criteria at 12, 18, 24 and 28 weeks, but not at 8 weeks, the pre-specified primary endpoint. The GMC of one HEPLISAV lot was slightly higher than the other two lots, which resulted in not meeting the consistency criteria at week 8.
By SPR, the results met the pre-specified consistency criteria at 12, 18, 24 and 28 weeks, but not at 8 weeks.
At all of these timepoints, each lot of HEPLISAV was superior to Engerix-B."

$DVAX Conference Call / Webcast Tomorrow on Topline Phase 3 Data and Q2 Financial Results

2011-07-19T19:03:00.000-04:00

Dynavax Technologies Corporation said it will host a conference call and webcast tomorrow, Wednesday, July 20, 2011, to discuss topline Phase 3 data and its second quarter 2011 financial results at 9:00 a.m. Eastern Daylight Time / 6:00 a.m. Pacific Daylight Time.

To join the Conference Call, please dial 1-877-280-7280. International callers can dial 1-707-287-9365. A telephonic replay of the discussion will be available 90 minutes after its conclusion and through August 3, 2011 by dialing 1-855-859-2056, access code: 85190076. International callers can dial 1-404-537-3406, access code: 85190076.

The webcast can be accessed on Dynavax's website at http://investors.dynavax.com/events.cfm . A webcast replay of the discussion will be available on Dynavax's website, 90 minutes after its conclusion and through August 3, 2011.

Source:

$NABI Announces Results of First NicVAX(R) Phase III Clinical Trial

2011-07-18T09:14:00.000-04:00

ROCKVILLE, Md., July 18, 2011 (GLOBE NEWSWIRE) -- Nabi Biopharmaceuticals (Nasdaq:NABI - News) today announced that NicVAX(R) (Nicotine Conjugate Immunotherapeutic) did not meet its primary endpoint in the company's first of two confirmatory Phase III clinical trials.

A preliminary assessment of the trial data showed that subjects treated with NicVAX quit smoking at a similar rate of approximately 11% compared to subjects who received placebo. As in previous trials, NicVAX was well-tolerated with a clinically acceptable safety and tolerability profile.

The study was a double-blinded, placebo-controlled trial of 1,000 patients. The primary endpoint of the study was the abstinence rate for 16 weeks ending at 12 months. Abstinence was evaluated by self-reported cigarette consumption and biologically verified by exhaled carbon dioxide. Secondary endpoints included the abstinence rate at various time intervals, safety and immunogenicity, and the effect of NicVAX on withdrawal symptoms, cigarette consumption, smoking satisfaction and nicotine dependency.

"We are clearly surprised and deeply disappointed with the results of this first NicVAX Phase III trial," Raafat Fahim, President and Chief Executive of Nabi Biopharmaceuticals said. "We are in the process of assessing the reasons for these unexpected data, as we await the results of the second Phase III trial. Data from this second trial may provide clues that could help explain the disappointing results from the first trial. In the meantime, the board of directors is actively evaluating any and all appropriate strategic alternative actions to preserve shareholder value, while management is working to further control the operational expenses of the company."

The company will host a live webcast at 10:00 a.m. EDT today to discuss these results.

Transcept Pharmaceuticals Expects Complete Response Letter on Intermezzo® New Drug Application Based on Teleconference with FDA

2011-07-12T21:36:00.000-04:00

POINT RICHMOND, Calif., July 12, 2011 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced today that it expects to receive a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the resubmitted New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet) on or before July 14, 2011, the PDUFA date assigned by the FDA for completion of the Intermezzo® NDA review. The FDA issues a Complete Response Letter to indicate that the review cycle for an NDA is complete and that the application is not ready for approval. The Intermezzo® NDA seeks approval to market Intermezzo® for use as needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

This update from Transcept is based on a teleconference with the FDA held earlier today during which the FDA expressed continued concerns about the safety profile of Intermezzo® based on information in the resubmitted NDA. Until Transcept receives the anticipated Complete Response Letter, the company has limited information as to the full extent of FDA concerns. After the Complete Response Letter is received, Transcept will announce additional information on the content of the letter and the company's plans for the future regulatory development of Intermezzo®.

http://www.prnewswire.com/news-releases/transcept-pharmaceuticals-expects-complete-response-letter-on-intermezzo-new-drug-application-based-on-teleconference-with-fda-125456478.html

$GENT Announces NDA Submission for Defibrotide

2011-07-06T21:23:00.000-04:00

VILLA GUARDIA (COMO), Italy, Jul 6, 2011 (GlobeNewswire via COMTEX) -- Gentium S.p.A. GENT -0.10% (the "Company") today announced that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for Defibrotide for the treatment of hepatic veno-occlusive disease (VOD) in adults and children undergoing hematopoietic stem-cell transplantation (HSCT).

"If approved, Defibrotide would become the first drug approved for the treatment of VOD, a serious and potentially fatal complication of hematopoietic stem-cell transplantation," stated Dr. Khalid Islam, Chairman and Chief Executive Officer of Gentium S.p.A. "Defibrotide has been used as an investigational drug in more than 250 clinics across 33 countries in the on-going global named-patient programs, and the United States expanded access study. We are committed to working with the FDA on the approval of Defibrotide and with our partner, Sigma-Tau Pharmaceuticals, Inc., on the future commercialization of Defibrotide."

Gregg Lappointe, CEO of Sigma-Tau Pharmaceuticals, Inc., commented, "We congratulate Gentium on reaching this important milestone and moving toward U.S. regulatory approval for Defibrotide. We are committed to working closely with Gentium to ensure a successful launch in the U.S. for this potentially lifesaving therapeutic candidate."

The efficacy of Defibrotide to treat hepatic VOD in HSCT patients is supported by data from a multi-center Phase 3 historically-controlled trial, evaluating Defibrotide for the treatment of severe VOD (patients with VOD and multi-organ failure), a Phase 2 dose finding study, and interim data reported from the ongoing Phase 3 expanded access U.S. Treatment IND program in patients with severe hepatic VOD. Additional data include a Phase 3 randomized controlled study of Defibrotide in the prevention of hepatic VOD in pediatric HSCT patients. Defibrotide has generally been well-tolerated in the clinical setting, and results in more than 1,300 patients to date have shown that generally Defibrotide does not appear to increase the risk of complications in HSCT patients.

Defibrotide has been granted orphan drug designation by the FDA to treat severe VOD. Orphan drug designation is a special status given to products for diseases or conditions that affect fewer than 200,000 people in the United States. If the FDA approves the NDA for this use of Defibrotide, before approving a NDA filed by anyone else for the same use, the orphan drug status will grant us limited market exclusivity for seven years from the date of the FDA's approval of our NDA.

Defibrotide has also been granted "fast track" designation by the FDA for the treatment of severe VOD in recipients of stem cell transplants. Fast track is a process designed to facilitate the development and expedite the review of drugs that are intended to treat serious diseases and fill an unmet medical need.

Gentium recently filed a marketing authorization application with the European Medicines Agency (EMA) for the prevention and treatment of hepatic veno-occlusive disease (VOD) in adults and children undergoing stem-cell transplantation therapy. The application was accepted and granted an accelerated assessment by the EMA on May 25, 2011

Oncolytics Biotech� Inc. Collaborators Present Positive REOLYSIN� Clinical Trial Results at the 14th World Conference on Lung Cancer

2011-07-06T21:11:00.000-04:00

Oncolytics Biotech� Inc. Collaborators Present Positive REOLYSIN� Clinical Trial Results at the 14th World Conference on Lung Cancer

CALGARY, July 6, 2011 /PRNewswire/ - Oncolytics Biotech Inc. (TSX:ONC, NASDAQ: ONCY) ("Oncolytics") today announced that a presentation covering interim preliminary results from a Phase 2 clinical trial using intravenous administration of REOLYSIN® in combination with paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC) with Kras or EGFR-activated tumours was made today at the International Association for the Study of Lung Cancer World Conference on Lung Cancer. The conference is being held in Amsterdam, the Netherlands from July 3rd - 7th 2011.

The presentation, entitled "Phase II study of reovirus with paclitaxel (P) and carboplatin (C) in patients with metastatic non-small cell lung cancer (NSCLC) who have Kras or EGFR-activated tumors", was given by Dr. Miguel Villalona-Calero, principal investigator for the study, and indicated that 22 patients had received Reovirus (REOLYSIN) (3 x 1010 TCID50) intravenously daily on days one to five, in combination with carboplatin and paclitaxel. Initial doses used were carboplatin AUC 6 on day one, and palitaxel 200 mg/m2, on day one of each 21-day cycle. Due to exacerbation of prior gastrointestinal conditions and febrile neutropenia (one each) in the first two patients, doses were reduced to paclitaxel 175 mg/m2 and carboplatin AUC 5

$TTNP Provides Update on Confirmatory Phase 3 Study of Probuphine

2011-06-30T07:41:00.000-04:00

SOUTH SAN FRANCISCO, CA--(Marketwire - 06/30/11) - Titan Pharmaceuticals, Inc. (OTC.BB:TTNP - News) today provided an update on its recent communications with the U.S. Food and Drug Administration (FDA) regarding the Statistical Analysis Plan (SAP) for the company's confirmatory Phase 3 study of Probuphine™ for patients with opioid dependence.

Based upon its ongoing dialogue with the FDA and to maintain the trial's clinical integrity, Titan will conduct primary efficacy analyses comparing the Probuphine and placebo arms using the trial's protocol-specified primary endpoint of the cumulative distribution function of the percent negative urine samples, as well as an additional analysis of this urine toxicology that will incorporate patients' self-reports of illicit opioid use, as requested by the FDA. Specifically, this additional analysis comparing the Probuphine and placebo arms incorporates patients' self-reported data to ensure that within the assessment time period, the number of positive urine test results correspond to at least the number of days of opioid use reported by the patient. Titan has retrospectively conducted this same type of analysis on the cumulative distribution function of the percent negative urines incorporating patient self-report data from its first controlled Phase 3 study (PRO-805) of Probuphine in patients with opioid dependence, with the findings fully supporting the previously reported positive results. The FDA has indicated that it will put primary emphasis on this additional efficacy analysis when reviewing any New Drug Application for the approval of Probuphine.

With this clarity around the trial's Statistical Analysis Plan, Titan will now commence the unblinding and analysis of the data from its Phase 3 confirmatory clinical trial and expects to report top-line results in July 2011.

http://finance.yahoo.com/news/Titan-Pharmaceuticals-iw-4149543373.html?x=0&.v=1

$DARA Presented Positive Results Of Its Phase I Study For DB959 At The Amer Diabetes Assoc Scientific Session

2011-06-28T08:58:00.000-04:00

RALEIGH, N.C., June 28, 2011 (GLOBE NEWSWIRE) -- Today DARA BioSciences, Inc. (Nasdaq:DARA - News) announced the positive results of a randomized, placebo-controlled, double-blind, escalating single-dose study to evaluate the safety, tolerability, pharmacokinetics and food effect of DB959Na in healthy male and female volunteers. The presentation provided details on the company's lead oral diabetes drug candidate DB959.
A summary of the study results (DB959-101) follows:
SAFETY

No moderate, severe, or serious adverse reactions occurred.
Tolerability was equivalent between active and placebo groups; all doses tested were well tolerated.
No clinically-significant physical exam, vital sign, blood, urine or electrocardiogram changes were observed.
Maximum tolerated dose (MTD) for a single dose was not reached in this study. Therefore the MTD is higher than 200 mg., the top dose studied here, and is estimated to be ten times the anticipated human dose.

PHARMACOKINETIC

PK parameters are consistent with once/day dosing.
DB959 is not excreted unchanged in the urine.
A high fat meal slightly delays absorption of DB959.

The safety and PK results of DB959-101 provide support for the continued clinical development of DB959. A second clinical study is nearing completion with results expected to be available during Q3 2011.

ASTM Upcoming catalysts in 2011

2011-06-27T21:49:00.000-04:00

ASTM looks to have a busy 2H 2011 with the anticipated start of the ph3 trial for Ixmyelocel-T in critical limb ischemia cases and ph2 results of Ixmyelocel in DCM. See a summary below.

Drug/Compound: Ixmyelocel-T

Target:
Patient-specific multicellular therapy expanded from a patient's own bone marrow and delivered directly to damaged tissues, this trial is focused on the potential treatment for critical limb ischemia.

Catalyst:
In October 2010, Aastrom submitted two SPA requests to the FDA, one for a “no option” patient population and another for a “poor option” patient population. The no option SPA request focuses on patients that have exhausted all other treatment options with the exception of amputation. The poor option SPA request focuses on patients that have not yet exhausted all other treatment options; however the options available are associated with poor outcomes. These will pave the way toward the start of phase 3 trials.

Timing: July/August 2011
--------------------------------------------------------------------------------------------------------

Drug/Compound: ixmyelocel-T

Target
Dialated Cardiomyophaty, a condition in which the heart becomes weakened and enlarged, and it cannot pump blood efficiently. The decreased heart function can affect the lungs, liver, and other body systems.

Catalyst Ph2 surgical trial program of ixmyelocel-T in dilated cardiomyopathy, dubbed IMPACT-DCM, initiated with 40 patients in Q42008. The six-month data from the IMPACT-DCM interim analysis, ixmyelocel-T is safe and no adverse events were found to be associated with the therapy. The 12-month data from the IMPACT-DCM clinical study will be reported in Q3.

Timing: Q32011

--------------------------------------------------------------------------------------------------------

Drug/Compound: ixmyelocel-T

Target:
Dialated Cardiomyophaty a condition in which the heart becomes weakened and enlarged, and it cannot pump blood efficiently. The decreased heart function can affect the lungs, liver, and other body systems.

Catalyst:
ph2 initiated in April 2010 and has 21 patients enrolled in the study. Aastrom expects to report six-month results from the Catheter-DCM phase 2 trial in Q32011

Timing: Q32011

Disclosures: no position or plan to take in next 72hrs.

$CBRX NDA for PROCHIEVE� Vaginal Progesterone Gel Accepted for Filing by FDA

2011-06-27T07:56:00.000-04:00

<a href="http://www.prnewswire.com/news-releases/columbia-laboratories-nda-for-prochieve-vaginal-progesterone-gel-accepted-for-filing-by-fda-124584738.html">Columbia Laboratories' NDA for PROCHIEVE� Vaginal Progesterone Gel Accepted for Filing by FDA</a>

PDUFA date 2/26/2012

$EPCT Receives Initial FDA Comments on Application for Ceplene(R) Special Protocol Assessment

2011-06-27T07:50:00.000-04:00

EpiCept Corporation (nasdaq and nasdaq omx stockholm exchange:EPCT) today announced that it has received initial written responses from the U.S. Food and Drug Administration (FDA) regarding the Company's application for a Special Protocol Assessment (SPA) of the Ceplene(R) (histamine dihydrochloride) Phase III protocol. Ceplene, which is administered in conjunction with low-dose interleukin-2 (IL-2), is EpiCept's maintenance therapy for patients with acute myeloid leukemia (AML) in first remission. Among those responses, the FDA noted that in contrast to its earlier position it is now proposing that the trial attempt to isolate Ceplene's effect by including an IL-2 monotherapy arm in the trial protocol. The FDA has invited the Company to request a meeting to discuss its responses to the Company's application.

source: http://www.marketwatch.com/story/epicept-receives-initial-fda-comments-on-application-for-ceplener-special-protocol-assessment-2011-06-27?reflink=MW_news_stmp

$LCI FDA approval of its Morphine Sulfate Oral solution

2011-06-24T09:39:00.000-04:00

Lannett Receives FDA Approval for Morphine Sulfate Oral Solution NDA
Last update: 6/24/2011 9:34:00 AM
PHILADELPHIA, Jun 24, 2011 (BUSINESS WIRE) -- Lannett Company, Inc. (LCI) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's 505(b)(2) New Drug Application (NDA) for Morphine Sulfate Oral Solution on June 23, 2011. Sales of Morphine Sulfate Oral Solution for the last 12 months at Average Wholesale prices (AWP) were approximately $31.7 million, according to Wolters Kluwer. The company expects to commence shipping the product shortly.

FDA Accepts $ENDP Complete Response for New Formulation of OPANA® ER - Yahoo! Finance

2011-06-23T18:09:00.000-04:00

FDA Accepts Endo Pharmaceuticals' Complete Response for New Formulation of OPANA® ER - Yahoo! Finance:

"CHADDS FORD, Pa., June 23, 2011 /PRNewswire/ -- Endo Pharmaceuticals (Nasdaq:ENDP - News) announced today that it received notification from the U.S. Food and Drug Administration (FDA) that Endo's complete response to the FDA's Jan. 7, 2011 Action Letter relating to Endo's new drug application (NDA) for a new formulation of OPANA ER has been accepted. The new formulation was developed in partnership with Grunenthal GmbH and is designed to provide some resistance to certain types of product manipulation. FDA has set a Prescription Drug User Fee Act (PDUFA) date of Dec. 13, 2011."

$INFI Expands Clinical Development Program for IPI-926, an Oral Smoothened Antagonist Targeting the Hedgehog Pathway

2011-06-22T21:16:00.000-04:00

Infinity Expands Clinical Development Program for IPI-926, an Oral Smoothened Antagonist Targeting the Hedgehog Pathway - MarketWatch:

"CAMBRIDGE, Mass., Jun 22, 2011 (GlobeNewswire via COMTEX) -- Infinity Pharmaceuticals, Inc. INFI +0.11% today announced that it is expanding its clinical development program for IPI-926, a novel, oral small molecule that inhibits Smoothened, a key component of the Hedgehog pathway. As part of this expansion, Infinity plans to initiate an exploratory Phase 2 clinical trial in patients with myelofibrosis, an incurable malignancy of the bone marrow which is characterized by the replacement of normal bone marrow by fibrotic tissue and the production of blood cells in other organs, such as the spleen and liver.
The single-arm, Phase 2 trial is designed to evaluate the safety and efficacy of IPI-926 administered orally once daily in up to 45 patients with myelofibrosis. The primary endpoint of the trial is hematologic response rate. The trial is expected to begin in the third quarter of 2011.
'The important role of the Hedgehog pathway in pathogenic fibrosis leads us to believe that IPI-926 may have application across a range of malignancies, including pancreatic cancer and myelofibrosis, in which malignant cells create a dense, fibrotic, protective microenvironment via the Hedgehog pathway signaling to the stroma,' stated Pedro Santabárbara, M.D., Ph.D., chief medical officer at Infinity. 'While other agents in development for the treatment of myelofibrosis reduce spleen size, there is still a significant need for novel treatment options that can directly target the malignant fibrosis underlying this disease.'"

$ACHN Initiates 12-Week Dosing in Phase 2 Trial of ACH-1625 for the Treatment of Chronic Hepatitis C

2011-06-22T21:13:00.000-04:00

Achillion Initiates 12-Week Dosing in Phase 2 Trial of ACH-1625 for the Treatment of Chronic Hepatitis C - MarketWatch:

"NEW HAVEN, Conn., Jun 22, 2011 (GlobeNewswire via COMTEX) -- Achillion Pharmaceuticals, Inc. ACHN -0.83% today announced that the Company has initiated patient dosing in segment 2 of its Phase 2 clinical trial of ACH-1625 for the treatment of hepatitis C virus (HCV) for genotype 1 treatment naïve HCV-infected patients. ACH-1625, discovered and advanced by Achillion, is a potent small molecule inhibitor of HCV protease, an enzyme necessary for viral replication.
The clinical trial has advanced into the second segment of a Phase 2a, randomized, double-blind trial evaluating the safety, tolerability and antiviral activity of oral ACH-1625 in combination with standard of care (SOC) consisting of pegylated interferon alfa-2a and ribavirin. Patients will be randomized to receive once daily doses of 200 mg, 400 mg or 800 mg of ACH-1625 in combination with SOC for 12 weeks of dosing. Patients will continue to receive an additional 12 weeks of pegylated interferon alfa-2a and ribavirin and eligible to discontinue treatment at week 24 if they achieve extended rapid virologic response (eRVR) at week 12. Patients who do not achieve an eRVR will continue to receive SOC until week 48.
The trial will take place in the United States and Europe and is designed to enroll approximately 60 HCV-infected patients. The 12-week complete early virologic response (cEVR) trial results are anticipated to be announced in the fourth quarter of 2011."

$FCSC LaViv approved

2011-06-22T08:53:00.002-04:00

Congrats to longs

http://www.thestreet.com/story/11161235/1/fibrocell-receives-fda-approves-for-laviv.html

$THLD concludes recruitment in pancreatic cancer drug Phase 2 trial

2011-06-22T08:13:00.000-04:00

Threshold Pharma concludes recruitment in pancreatic cancer drug Phase 2 trial - Pharmaceutical Business Review:

"Threshold Pharmaceuticals has concluded patient recruitment in a multi-center, randomized, controlled, crossover Phase 2 clinical trial of TH-302 in patients with pancreatic cancer.
TH-302 is a novel small molecule tumor selective hypoxia-activated prodrug (HAP) that specifically targets tumor hypoxia and is applicable to a broad range of solid tumors.
Earlier, the company targeted to recruit around 165 patients, but the company has now recruited approximately 200 patients in the trial, which has automatically increased the statistical power of the study to greater than 80%.
The primary endpoint of the trial is progression-free survival.
However, the secondary endpoints are overall response rate, overall survival, event-free survival, CA 19-9 response rate as well as various safety parameters"

$XXII Files Investigational New Drug Application and Fast Track Request for X-22; Phase II-B Clinical Trial to Commence Immediately Upon FDA Clearance -

2011-06-22T08:07:00.001-04:00

22nd Century Files Investigational New Drug Application and Fast Track Request for X-22; Phase II-B Clinical Trial to Commence Immediately Upon FDA Clearance - MarketWatch:

"WILLIAMSVILLE, N.Y., Jun 22, 2011 (BUSINESS WIRE) -- 22nd Century Group, Inc. XXII 0.00% , a company focused on smoking cessation and tobacco harm reduction, announced today that 22nd Century Limited, LLC submitted an Investigational New Drug Application (IND) to the U.S. Food & Drug Administration (FDA) for X-22, a prescription smoking cessation aid in development.
X-22 consists of a kit of very low nicotine (VLN) cigarettes made from 22nd Century's proprietary tobacco. X-22 cigarettes for 22nd Century's Phase II-B clinical trial contain 97% less nicotine than Marlboro(R) Gold, the U.S. cigarette market leader, formally known as Marlboro Lights(R). The X-22 therapy protocol allows patients to smoke X-22 cigarettes without restriction over the 6-week treatment period to facilitate the goal of quitting by the end of 6 weeks.
Immediately upon FDA clearance of the IND, 216 smokers will be enrolled in a multicenter Phase II-B clinical trial. Primary endpoint results of the study, four weeks of continuous abstinence from smoking, are expected to be available this November. Quit rates of patients using X-22 cigarettes will be compared to those using an active control, cigarettes with conventional nicotine content"

$IMUC Issued Key Patent for ICT-107

2011-06-21T08:55:00.000-04:00

ImmunoCellular Therapeutics' Cancer Vaccine Technology Issued Key Patent

LOS ANGELES, Jun 21, 2011 (BUSINESS WIRE) -- ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular Therapeutics" or the Company")(IMUC), a biotechnology company focused on the development of novel immune-based cancer therapies, announced the issuance of a U.S. patent relating to a technology for the treatment of cancer for which the Company holds an exclusive, worldwide license. Patent No. 7,939,090, entitled "System and method for the treatment of cancer, including cancers of the central nervous system," covers the combination of a dendritic cell based vaccine combined either before or concurrently with chemotherapy at the recurrence of the disease. The Company believes that in the treatment of cancer, particularly cancers of the central nervous system such as glioblastoma multiforme (GBM), a dual therapeutic approach that includes the administration of a dendritic cell-based cancer vaccine combined with a regimen of chemotherapy could substantially enhance the clinical efficacy of treatment.
"This patent has applicability to multiple types of cancer, including our first clinical target, glioblastoma," said Manish Singh, Ph.D. president and CEO of ImmunoCellular Therapeutics. "ICT-107, the Company's dendritic cell based vaccine candidate for the treatment of GBM, elicits a cytotoxic tumor reactive response that in combination with chemotherapy might fundamentally alter tumors by priming their death machinery."
ImmunoCellular Therapeutics recently announced the expansion of its Phase II trial of ICT-107 from up to 15 clinical centers to 20 or more. The Phase II trial of ICT-107 is a double-blind, placebo-controlled, 2:1 randomized study designed to evaluate the safety and efficacy of ICT-107 in patients with newly diagnosed GBM. The study is enrolling patients at medical institutions in collaboration with well known experts and opinion leaders in neuro-oncology at those sites.
In the Phase I clinical study of ICT-107 in GBM, 16 newly diagnosed patients who received the vaccine in addition to standard of care of surgery, radiation and chemotherapy demonstrated a one year overall survival of 100 percent and a two year survival of 80 percent. The study's median progression free(PFS) survival of 16.9 months compared favorably to the historic median PFS of 6.9 months. 10 of the 16 patients continue to survive. This compares favorably with historical 61.1 percent one-year and 26.5 percent two-year survival based on the standard of care alone. The data shows 6 out of the 16 (37.6%) newly diagnosed patients who received ICT-107 continue to show no tumor recurrence, with 3 of these patients (18.8%) remaining disease-free for almost four years while the other 3 patients have gone more than 2 and a half years disease-free. No treatment related serious adverse events have been observed to date.

SOURCE: ImmunoCellular Therapeutics, Ltd.

$CRMD Announces SPA Agreement With FDA For Pivotal Phase 3 Trial Of CRMD001

2011-06-21T08:21:00.001-04:00

CorMedix Announces SPA Agreement With FDA For Pivotal Phase 3 Trial Of CRMD001:

"(RTTNews) - CorMedix Inc. (CRMD: News ) said it received a Special Protocol - Agreement letter from the U.S. Food and Drug Administration, or FDA, regarding a Special Protocol Assessment, or SPA, on the design of a pivotal Phase 3 trial for the company's oral formulation of CRMD001 in the prevention of Contrast-Induced Acute Kidney Injury. The SPA takes into consideration a modification to the dosing regimen contained in the previously submitted protocol.

The Phase 3 clinical study of CRMD001 will assess the efficacy and safety of CRMD001 in the reduction of morbidity and mortality in patients with Chronic Kidney Disease undergoing diagnostic or interventional cardiac procedures and receiving an iodinated radiocontrast agent."

$CYTK Announces Opening of Next Phase II Clinical Trial of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis

2011-06-21T07:57:00.000-04:00

Cytokinetics Announces Opening of Next Phase II Clinical Trial of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis - MarketWatch:

"SOUTH SAN FRANCISCO, CA, Jun 21, 2011 (MARKETWIRE via COMTEX) -- Cytokinetics, Incorporated CYTK 0.00% announced today that the company has opened enrollment in a second Phase II clinical trial of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS). CK-2017357, a fast skeletal muscle troponin activator, selectively activates the fast skeletal muscle troponin complex by increasing its sensitivity to calcium, which increases skeletal muscle force in response to neuronal input and delays the onset and reduces the degree of muscle fatigue. CK-2017357 is the lead drug candidate that has emerged from the company's skeletal muscle contractility program.
This clinical trial is a double-blind, randomized, placebo-controlled trial designed to evaluate the safety and tolerability of multiple doses of CK-2017357 in patients with ALS. An estimated 24 patients are planned to be enrolled at eight to ten study centers in the United States. Patients in the trial will be randomized to one of four different treatment groups, to receive daily oral doses of placebo, 125 mg, 250 mg, or 375 mg of CK-2017357, respectively, for two weeks; clinical assessments will take place at pre-determined times during the course of treatment. Patients will also participate in follow-up evaluations one week after their final dose"

$CRIS Investigational Skin Cancer Drug Found Effective In Mid-stage Study

2011-06-20T19:48:00.000-04:00

Investigational Skin Cancer Drug Found Effective In Mid-stage Study: "(RTTNews) -

Swiss pharmaceutical giant Roche Holding AG's (RHHBY.PK: News ) unit Genentech Monday stated that its investigational drug vismodegib showed positive results in a pivotal phase II study in people with basal cell carcinoma, an advanced form of skin cancer.

According to the American Cancer Society, skin cancer is the most common type of all known cancers and over 2 million skin cancers are diagnosed annually. Eighty percent of these are basal cell carcinomas or BCCs, which grow slowly from the bottom (basal), layer of the epidermis, or the outer skin layer.

BCCs develop on sun-exposed areas such as the head and the neck, rarely reach an advanced stage. But, in extreme cases, they can be incurable and even fatal.

Vismodegib is an investigational, oral medicine discovered by Genentech and jointly validated with therapeutic drug developer Curis Inc. (CRIS: News ). It is designed to target the underlying molecular driver of BCC. Genentech and its parent Roche are responsible for the clinical development and commercialization of the compound."

$PFE and $ACUR Announce FDA Approval of Oxectatm

2011-06-20T08:00:00.000-04:00

Pfizer and Acura Announce FDA Approval of Oxectatm (Oxycodone HCL, USP) CII | Benzinga.com: "Pfizer Inc. (NYSE: PFE) and Acura Pharmaceuticals Inc. (NASDAQ: ACUR [FREE Stock Trend Analysis]) announce the marketing approval from the U.S. Food and Drug Administration (FDA) of OXECTATM (oxycodone HCl, USP) Tablets CII. OXECTA is indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.

OXECTA is the first immediate-release oxycodone HCl medicine that applies technology designed to discourage common methods of tampering associated with opioid abuse and misuse. This AVERSION® Technology is a unique composition of commonly used pharmaceutical ingredients. Pfizer is licensing the technology in OXECTA from Acura.

Opioid medications are an important treatment option for patients with moderate to severe pain who are not adequately managed by other pain treatments. However, abuse and misuse of opioids is a serious public health issue that is the focus of a number of recent United States government initiatives."

Watchlist for week of June 20th - $FCSC, $LCI, $ALXA, $DRRX

2011-06-18T22:09:00.000-04:00

FCSC - PDUFA 6/22 azficel-T, proposed brand name laViv®,”
LCI - PDUFA 6/23 Morphine Sulfate Oral Solution.
ALXA - new drug application (NDA) on AZ-004 (Staccato loxapine) for the treatment of acute agitation in patients with schizophrenia or bipolar disorder by the end of July 2011.
DRRX/PTIE - PDUFA 6/23 Remoxy

Holding FCSC & TTNP

$TTNP PH3 study update for Probuphine

2011-06-17T13:53:00.000-04:00

SOUTH SAN FRANCISCO, CA -- (MARKET WIRE) -- 06/17/11 -- Titan Pharmaceuticals, Inc. (OTCBB: TTNP) today announced additional information following on its press release issued earlier today about its ongoing dialogue with the U.S. Food and Drug Administration ( FDA ) regarding the Statistical Analysis Plan (SAP) for its confirmatory Phase 3 study of Probuphine™.
The SAP for the confirmatory Phase 3 study of Probuphine™ was submitted to the FDA in the third quarter of last year and included statistical analyses similar to those previously agreed upon with the FDA and performed in the first controlled Phase 3 study. In late March this year Titan received comments from the FDA on the study protocol as a whole that included a comment on the primary analysis which needed further clarification. Titan immediately requested a meeting with the FDA to obtain further clarification.
In early May, Titan and FDA met via teleconference, clarifying the earlier comment and reaching an understanding on a type of additional analysis to be performed. The revised SAP submitted to the FDA included this analysis as an additional secondary endpoint. Titan also provided to the FDA this same type of analysis conducted retrospectively on the data from the first controlled Phase 3 study (PRO-805), which fully supported the previously reported positive results.
The letter from the FDA received yesterday essentially agrees with the proposed statistical analysis methodology, but requests that this be part of the primary analysis. Titan is seeking a telephonic meeting with the FDA to obtain clarity regarding their request and finalize the SAP expeditiously, and conduct the appropriate analyses. Additional information on the timeline will be provided following this discussion with the FDA .
Importantly, Titan has not unblinded the database nor analyzed any findings for the Phase 3 confirmatory trial and will not do so until final agreement on the SAP has been reached with the FDA

Reminder $ACUR PDUFA Tomorrow

2011-06-16T22:33:00.000-04:00

http://www.drugs.com/nda/acurox_101220.html

Good luck to those holding past tomorrow -

$NGSX Completes Phase 2 Enrollment Of NGX-1998 Topical Liquid Capsaicin Formulation Trial

2011-06-16T08:13:00.000-04:00

NeurogesX Completes Phase 2 Enrollment Of NGX-1998 Topical Liquid Capsaicin Formulation Trial: "SAN MATEO, Calif., June 16, 2011 /PRNewswire/ — NeurogesX, Inc. (NASDAQ:NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced the completion of patient enrollment in its Phase 2 clinical study of NGX-1998, a topical liquid formulation of high-concentration capsaicin, in patients with postherpetic neuralgia (PHN). NGX-1998 is being developed to provide safety, efficacy and tolerability that is at least comparable to Qutenza® (capsaicin) 8% patch with a shorter treatment time. A total of 183 patients were enrolled in the Phase 2 study."

$QRXPY to file NDA within two months -

2011-06-15T07:31:00.000-04:00

QRxPharma to file NDA within two months - U.S. Food and Drug Administration, QRxPharma, clinical trials - Australian Life Scientist:

"QRxPharma (ASX: QRX) is nearing the final hurdle in bringing its dual-opioid pain drug, MoxDuo, to market, with the company planning to file a New Drug Application (NDA) with the US Food and Drug Administration within the next two months.

MoxDuo IR capsules are a patented 3:2 fixed ratio combination of morphine and oxycodone that targets the acute pain market, a $2.5 billion segment of the $7 billion spent annually on prescription opioids in the US."

$ATHX reports positive results from early heart attack clinical trial

2011-06-14T18:20:00.000-04:00

Athersys reports positive results from early heart attack clinical trial:

"Athersys (NASDAQ:ATHX) reported that results from a phase 1 trial of its stem cell therapy suggest its MultiStem technology could hold benefits for heart attack patients.

The positive results from a one-year followup on the trial will pave the way for Cleveland-based Athersys to begin a phase 2 trial on heart attack patients later this year, according to a statement from the company.

Athersys’s MultiStem is an off-the-shelf stem cell treatment derived from the bone marrow of adults or other nonembryonic sources. The technology has shown promise in reducing inflammation, protecting damaged tissue and forming new blood vessels."

PCRX, Announces FDA Extension of EXPAREL™ PDUFA Target Date by Three Months

2011-06-14T07:56:00.000-04:00

Pacira Pharmaceuticals, Inc. Announces FDA Extension of EXPAREL™ PDUFA Target Date by Three Months:

"U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) for EXPAREL™ (Bupivacaine Extended-Release Liposome Injection) by three months. The new PDUFA goal date is October 28, 2011.
The FDA requested additional information from Pacira, which the company has submitted. The FDA determined that this information constituted a major amendment. The agency has the option to extend the PDUFA goal date when a sponsor submits a major amendment to an NDA within three months of the PDUFA goal date to provide the FDA time to complete the review."

$CYTR Positive ph2 results for Bafetinib

2011-06-13T10:11:00.000-04:00

CytRx Reports Positive Preliminary Results from ENABLE Phase 2 Clinical Trial with Bafetinib in Patients with Relapsed B-Cell Chronic Lymphocytic Leukemia Business Wire:

"LOS ANGELES--(BUSINESS WIRE)--CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced that preliminary results from its ENABLE Phase 2 proof-of-concept trial demonstrated that bafetinib, the Company’s Bcr-Abl, Lyn and Fyn kinase inhibitor, was clinically active in a group of patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL) who have failed several other treatments for their cancer. Based on this indication of clinical activity and the low incidence of adverse events, additional patients enrolled in the ENABLE Phase 2 clinical trial will receive bafetinib as a single agent at a higher dose."

$ZIOP receives FDA acceptance to initiate oncology drug trial - Pharmaceutical Business Review

2011-06-13T09:40:00.000-04:00

Ziopharm receives FDA acceptance to initiate oncology drug trial - Pharmaceutical Business Review:

"Ziopharm Oncology has received the US Food and Drug Administration (FDA) acceptance for its investigational new drug (IND) application to commence ZIN ATI-001 clinical study in oncology.
The Phase I trial is expected to assess safety along with the immunological and biological effects of ZIN ATI-001 in patients with melanoma.
ZIN ATI-001 employs an adenoviral vector to deliver, directly into the patient's own cells, a gene which expresses Interleukin-12 (IL-12,a potent, naturally occurring anticancer cytokine central to the initiation and regulation of cellular immune responses.
Ziopharm board of director RJ Kirk said ZIN ATI-001, which offers an effective, yet simpler approach to introducing IL-12 therapy, is the first of many products they expect to introduce into the clinic as partners over the next two years.
'Ziopharm's understanding of the development spectrum, from preclinical work through large outcome studies, ensures that the great promise of this technology is delivered quickly and intelligently,' Kirk said"

My Watchlist for week of 6/13

2011-06-12T17:02:00.000-04:00

ACUR - PDUFA 6/17 Acurox
FCSC - PDUFA 6/22 azficel-T, proposed brand name laViv®,”
LCI - PDUFA 6/23 Morphine Sulfate Oral Solution.
ALXA - new drug application (NDA) on AZ-004 (Staccato loxapine) for the treatment of acute agitation in patients with schizophrenia or bipolar disorder by the end of July 2011.

Holding FCSC & ANX

Will moving my blog here in the future

2011-06-12T12:25:00.000-04:00

http://biotechtrader.wordpress.com/