Cel-Sci Corp. began a carefully designed Phase III trial of Multikine, its investigational immunotherapy for head and neck cancer. Because Multikine is designed to recruit the support of a mostly healthy immune system, Cel-Sci is making a headlong charge at the goal of first-line therapy, instead of trying to develop the product in patients who have already received surgery, radiation and chemotherapy, and have suppressed or damaged immune systems as a result. If Cel-Sci can prove the therapy works in the narrow three-week testing window granted by the FDA, Multikine stands to replace a standard of care that has changed little in half a century. Read More
Lupus took the spotlight twice in November, first when Resolve Therapeutics LLC entered this active area of drug development and licensed compounds and technology targeting the interferon-alfa pathway from the University of Washington School of Medicine in Seattle. Read More
"For millions of years, we have evolved together with a lot of bugs," Bernat Olle told BioWorld Today. "We have come to think of them as bad. But many of them are harmless bystanders, and others are actually beneficial." Read More
The long-standing relationship between drug developers and academia is changing, with big pharma seeking broader and more direct access to innovative research being done at universities. But as the captains of the drug industry cozy up to the ivory towers, it remains to be seen what role the venture capitalists and biotechs that have historically served as middle-men between these two parties will play. Read More
• Endo Pharmaceuticals Inc., of Chadds Ford, Pa., received FDA approval of Fortesta (testosterone 2 percent gel) for low testosterone. Endo licensed the drug, which received an approvable letter in 2009, from Prostrakan Group plc. (See BioWorld Today, Aug. 27, 2009.) Read More
• DARA BioSciences Inc., of Raleigh, N.C., raised $4.8 million through a public offering of stock and warrants. The company sold 4,800 units priced at $1 ,000 apiece, with each unit consisting of one Series A share convertible into 400 common shares, one Class A warrant to purchase 200 common shares, and one Class B warrant to purchase 200 shares. Ladenburg Thalmann & Co. Inc. served as the placement agent. Proceeds will support DARA's pain and diabetes programs. Shares of DARA (NASDAQ:DARA) fell 33 cents, or 11 percent, to close at $2.78 on Wednesday. Read More
• Ziopharm Oncology Inc., of New York, dosed its first patient in a Phase I trial of ZIO-201 (palifosfamide) with etoposide and cisplatin/carboplatin for small cell lung cancer. Palifosfamide is currently in Phase III for soft tissue sarcoma. The trial is being carried out at the Indiana University Cancer Center and will enroll 12 to 15 patients. It will evaluate safety of the combination drug regimen for a planned randomized Phase II trial. Read More
