Despite high hopes for oral Akt inhibitor perifosine, the drug failed to improve overall survival in a Phase III colorectal cancer (CRC) trial, sending shares of partners Keryx Pharmaceuticals Inc. and Aeterna Zentaris Inc. tumbling Monday and shifting investor attention to each firm's other late-stage programs. Read More
At last year's annual meeting of the American Society of Hematology, Pharmacyclics Inc.'s PCI-32765 wowed with its ability to fight chronic lymphocytic leukemia. This week at the annual meeting of the American Association for Cancer Research, the drug – now named ibrutinib and partnered with of Johnson & Johnson unit Janssen Research and Development LLC, in a deal that could ultimately be worth nearly $1 billion – showed its qualities in another type of cancer. Read More
AVI BioPharma Inc.'s Duchenne's muscular dystrophy (DMD) candidate eteplirsen hit its primary endpoint of significantly increasing dystrophin in a Phase IIb trial, although shares plummeted on Monday over the lack of clinical outcome improvement. Read More
AlloCure Inc. raised $25 million for a Series B venture financing, welcoming new investor Lundbeckfond Ventures, as well as previous investors SV Life Sciences and Novo A/S. Read More
• Inovio Pharmaceuticals Inc., of Blue Bell, Pa., said it received a Department of Defense (DoD) Small Business Innovation Research grant to advance the development of a low-cost, non-invasive surface electroporation delivery device and test its use in combination with Inovio's synthetic DNA vaccines against viruses with bioterrorism potential, including hanta, puumala, arenavirus and pandemic influenza. Read More
• Oncolytics Biotech Inc., of Calgary, Alberta, completed enrollment in the first stage of its Phase III trial examining Reolysin in combination with paclitaxel and carboplatin in 80 patients with platinum-refractory head and neck cancers. Read More
• Ampio Pharmaceuticals Inc., of Greenwood Village, Colo., reported that it reached a manufacturing and quality control agreement with Australia's Therapeutic Goods Administration for Zertane (low-dose tramadol). It plans to file the draft registration submission in June for the repurposed medication designed to treat premature ejaculation. No additional clinical trials are expected to be required. Read More
• ViiV Healthcare, of Brentford, UK, and Shionogi & Co. Ltd., of Osaka, Japan, said initial results indicated that once-daily dolutegravir, an integrase inhibitor, demonstrated noninferiority to twice-daily raltegravir in the SPRING-2 study in treatment-naïve HIV-1 patients. Read More
• Optimer Pharmaceuticals Inc., of San Diego, presented results from a post-hoc subgroup analysis of the company's two large Phase III trials, which demonstrated that cancer patients with Clostridium difficile-associated diarrhea (CDAD) had higher clinical cure rates, better sustained response and lower recurrence when treated with Dificid (fidaxomicin) tablets compared to oral vancomycin. Read More
