|Anthera Halts VISTA-16 Clinical Study; Peregrine Reports Data From Phase II Study|
|By Staff and Wire Reports|
|Friday, 09 March 2012 19:57|
Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, announced 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. The DSMB's recommendation was based on a review of the totality of the safety and efficacy data available for the VISTA-16 clinical study.
"Based on all the evidence we have seen regarding varespladib and secretory phospholipase and in light of previous study results, we were surprised by the recommendation from the DSMB," said Stephen Nicholls, MD, Cardiovascular Director of the Cleveland Clinic Coordinating Center for Clinical Research and chairman of the executive committee overseeing the VISTA-16 trial. "We believed that the study was coming along as expected, and this new information was totally unexpected and disappointing given the potential benefits of this drug."
Anthera has closed enrollment in the phase 3 VISTA-16 clinical study and informed all investigators to remove patients from therapy immediately. "While the Data Safety Monitoring Board information we received today was both surprising and disappointing, our focus is on the best interests of patients and making sure all this information is communicated to appropriate medical and regulatory authorities as quickly as possible," said Paul F. Truex, Anthera's President and Chief Executive Officer.
Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) PPHM -4.43% today announced top-line overall response rate (ORR) and current median progression free survival (PFS) estimates from its phase II trial comparing bavituximab plus carboplatin and paclitaxel versus carboplatin and paclitaxel alone in patients with front-line Stage IIIb and Stage IV non-small cell lung cancer (NSCLC).
Based on investigator assessments, patients treated with bavituximab plus carboplatin and paclitaxel demonstrated a current median PFS estimate of 5.8 months versus 4.6 months in patients treated with carboplatin and paclitaxel alone, a 26% improvement. These results are consistent with a prior phase II single-arm study testing the same bavituximab combination in front-line NSCLC patients which showed a 6.1 month median PFS and with several prior published studies with carboplatin and paclitaxel in front-line patients that showed approximately a 4.5 month median PFS. Based on independent central imaging reads, patients demonstrated a current median PFS estimate of 6.7 months for the bavituximab-containing arm and 6.4 months for the chemotherapy-only arm. Peregrine expects to report median overall survival (OS) from this trial in the second half of 2012.
"We are pleased that the PFS results for the bavituximab-containing arm by both local and central image interpretation actually met or exceeded our expectations going into the study. While the data from the investigator assessments were in alignment with previous published reports for carboplatin and paclitaxel and suggested an encouraging difference between the treatment arms, the unexpected long PFS estimate for the control arm based on central reads confounds our ability to fully interpret this secondary efficacy endpoint," said Joseph Shan, vice president, clinical & regulatory affairs at Peregrine. "We now await median OS data from this study which is the most clinically relevant endpoint from a drug development standpoint."
Further data from the study showed that based on an independent central imaging review of eligible patients, patients treated with bavituximab plus carboplatin and paclitaxel demonstrated an ORR of 25%, versus 23% in patients treated with carboplatin and paclitaxel alone. Investigator-determined response rates were 32% for bavituximab plus carboplatin and paclitaxel versus 31% for carboplatin and paclitaxel alone.
"We continue to be enthusiastic about the bavituximab program and look forward to the upcoming data from seven ongoing clinical studies in multiple solid tumor indications including the OS data from this study. While we had hoped the PFS results in this study would be more consistent, we are encouraged by what we have seen so far in the trial and now look forward to the final and perhaps most important endpoint from the study, median OS," said Steven W. King, president and chief executive officer of Peregrine. "We expect the remainder of the year to be an exciting one for the bavituximab program as data emerges from multiple solid tumor trials. In the coming months, we plan to unblind the second-line NSCLC Phase II trial and announce interim data from our Phase II trial in pancreatic cancer. In addition, we will be presenting bavituximab data at the upcoming annual AACR meeting on three of the four investigator-sponsored trials in various cancers."
Bavituximab is currently being tested in seven clinical studies including three randomized Phase II trials in front-line and second-line non-small cell lung cancer (NSCLC), front-line pancreatic cancer and four investigator-sponsored trials (ISTs) in additional oncology indications with clinical data from each study expected in 2012.
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