ANTH fails Phase 3 trial. Pipeline updates for CTIC PPHM BNVI OGXI + ASTM financing

Mar 10, 2012 No Comments by

Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH) announced that the VISTA-16 Data Safety Monitoring Board (DSMB) has recommended stopping the VISTA-16 clinical study due to a lack efficacy that could not be reasonably overcome in the remainder of the trial.  As a result the company has closed enrollment in the Phase 3 trial.

Cell Therapeutics, Inc. (NASDAQ: CTIC) gave a pipeline update in its latest 10K filing, pushing back expected timelines in a couple indications. In its September 2011 10Q the company noted that an interim analysis was expected in mid-2012 from its candidate Opaxio for patients with ovarian cancer. However the company was informed on On February 21, 2012 that the Data Monitoring Committee will perform four interim analyses instead of the previously-planned single interim analysis. The first interim analysis of overall survival is now expected in 2013. In September 2011, it also indicated that it planned to initiate a Phase 3 study of Tosedostat for patients with relapsed or refractory MDS in 2Q 2012. However, in its 10K filing it noted that the trial initiation will now occur in 2H 2012.

Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM) filed a mixed shelf allowing it from time to time offer and sell any combination common stock or warrants in one or more offerings for total gross proceeds of up to $150m.

It also announced top-line overall response rate (ORR) and current median progression free survival (PFS) estimates from its Phase 2 trial comparing bavituximab plus carboplatin and paclitaxel versus carboplatin and paclitaxel alone in patients with front line advanced non-small cell lung cancer (NSCLC).  Investigator-determined response rates were 32% for bavituximab plus carboplatin and paclitaxel versus 31% for carboplatin and paclitaxel alone.  The PFS estimate of 6.7 months for the bavituximab-containing arm compared with 6.4 months for the chemotherapy-only arm. Data from its trial in refractory patients are due 1H 2012. Interim data from its Phase 2 Pancreatic cancer trial are due 2012.

Bionovo, Inc. (OTC Link Platform: BNVI.PK) announced that it has reduced its workforce by over 90%. It is currently reviewing the status of the ongoing clinical trial for Menerba and noted that it does not currently have adequate internal liquidity to meet its cash needs.  If sufficient additional funds are not received in the near term, it may need to further curtail or cease operations.

Aastrom Biosciences, Inc. (Nasdaq:ASTM) announced that it has completed a $40 million private placement.

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) gave a pipeline update noting that it plans to initiate a new Phase 3 trial of custirsen in patients with prostate cancer in 2H 2012. Its other Phase 3 study, SYNERGY, evaluating a survival benefit in the first-line CRPC setting, continues to accrue patients and is expected to complete enrollment later this year. The company also expects to initiate a Phase 3 trial of custirsen in non-small cell lung cancer in 2H 2012.

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About the author

Currently residing in New Zealand, Mr. A.Burden holds a Master of Commerce in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.
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