• AmpliMed Corp., of Tucson, Ariz., said interim results from its ongoing Phase I/II trial of Amplimexon (imexon) in combination with dacarbazine in patients with advanced malignant melanoma show that, of 27 evaluable patients, five have had partial responses and seven have demonstrated stable disease, for an overall 44.4 percent clinical benefit rate. Data were presented at the Congress of Perspectives in Melanoma X and The Third International Melanoma Research Congress in Noordwijk, the Netherlands.
• Amylin Pharmaceuticals Inc., of San Diego, and Eli Lilly and Co., of Indianapolis, said study results indicated that exenatide improved blood sugar levels as effectively as biphasic insulin aspart 30/70 (NovoMix 30, Novo Nordisk A/S) for people with Type II diabetes who fail to achieve acceptable blood sugar control on both metformin and a sulfonylurea. During the one-year study, patients using exenatide showed improvements in fasting blood glucose, postprandial blood glucose and hemoglobin A1C. The treatment also resulted in an average reduction in body weight. The findings were presented at the 42nd annual meeting of the European Association of the Study of Diabetes in Copenhagen, Denmark.
• Gemin X Biotechnologies Inc., of Montreal, started a Phase II program to evaluate GX15-070 in several types of cancer. The product is a small molecule designed to inhibit all relevant members of the Bcl-2 protein family. Trials have been initiated in Hodgkin's lymphoma and in myelofibrosis with myeloid metaplasia. Both are multicenter, open-label, single-agent studies, with a primary endpoint of tumor response.
• Genzyme Corp., of Cambridge, Mass., reported two-year interim results from a Phase II trial comparing Campath (alemtuzumab) with Rebif (interferon beta-1a, Serono SA), showing that patients taking Campath at high and low doses experienced at least a 75 percent reduction in the risk for relapse after at least two years of follow up when compared to patients treated with Rebif. That difference was statistically significant at both the high and low doses of Campath, with a "p" value less than the prespecified value (p=0.00328) assigned for the two-year interim analysis. The 334-patient study is planned to continue for a third year, though Genzyme reported in September 2005 that it suspended dosing of Campath after three patients developed immune thrombocytopenic purpura. (See BioWorld Today, Sept. 19, 2005.)
• Javelin Pharmaceuticals Inc., of Cambridge, Mass., reported final results from its 353-patient Phase IIb study showing that Dyloject, a formulation of diclofenac for injection for moderate to severe postsurgical pain, met its primary endpoint of a linear dose response for pain relief over six hours, with each of the five doses (3.75 mg through 75 mg) separating statistically from placebo. The study also showed that Dyloject's analgesic effect occurred as early as five minutes post injection. Those data were presented at the 5th Congress of the European Federation of the International Association for the Study of Pain in Istanbul.
• MannKind Corp., of Valencia, Calif., completed patient enrollment in the pivotal long-term safety study of Technosphere Insulin, an inhaled formulation. More than 1,800 subjects were enrolled in the study, which will evaluate the pulmonary safety of the product in patients with Type I and Type II diabetes, as well as a subgroup of individuals without diabetes. The study is part of a Phase III program, which includes additional pivotal studies that are recruiting at centers in the U.S., Europe and Latin America.
• Prometic Life Sciences Inc., of Montreal, plans to expand its Phase Ib/II trial of PBI-1402 in anemia to multiple sites in Canada and Europe after receiving positive toxicology results. Preliminary analysis of those findings indicates that the product has a promising safety profile devoid of severe toxicity. Additional studies will be undertaken to ensure its safety. The company also will initiate PBI-1393 clinical trials for advanced cervical cancer.
