• DOR BioPharma Inc., of Miami, said results of a Phase I trial show that RiVax, a recombinant vaccine against ricin toxin, is well tolerated and induces antibodies in humans that neutralize ricin toxin. The trial enrolled 15 volunteers in groups of five, who were vaccinated with three successive monthly injections of the same dose level. The results will be published this week in the online edition of the Proceedings of the National Academy of Sciences.

• Elite Pharmaceuticals Inc., of Northvale, N.J., said the FDA accepted its investigational new drug application for its once-daily oxycodone product, OxyQD, which uses Elite's sustained-release technology. A pilot Phase I study will evaluate the extent of absorption of oxycodone from OxyQD vs. an existing commercial product, Oxycontin, a twice-daily opioid product.

• PharmaMar SA, of Madrid, Spain, said its investigational new drug application was accepted to begin clinical testing of Zalypsis (PM00104/50), a marine antitumor agent. The company plans to start testing the drug against solid tumors and lymphoma in the second quarter. The drug is in Phase I development in Europe for those same indications.

• Sunesis Pharmaceuticals Inc., of South San Francisco, started treating patients in a Phase I trial of SNS-032, a small-molecule inhibitor of cyclin-dependent kinases 2, 7, and 9. The study will evaluate the safety and preliminary antitumor activity of the drug in patients with advanced solid tumors. Once a maximum-tolerated dose has been identified, enrollment will expand to 24 patients with lung cancer, breast cancer or melanoma.

• Trophos, of Marseille, France, completed Phase I trials of its lead compound, TRO19622, demonstrating that single and multiple doses were found to be safe and well tolerated in healthy adults, and that it achieved the effective clinical dose when administered orally. The company expects to begin a pivotal Phase II/III trial in amyotrophic lateral sclerosis in the fourth quarter. TRO19622 has been granted orphan status for ALS in the U.S., and for the treatment of spinal muscular atrophy in the European Union.

• Vion Pharmaceuticals Inc., of New Haven, Conn., plans to conduct a pivotal Phase II trial of Cloretazine, a cancer drug, in elderly patients with poor-risk acute myelogenous leukemia, specifically those with de novo poor-risk AML. The company said it expects to begin the trial as soon as possible, and plans to accrue about 85 patients. Data from an earlier Phase II study showed that a response rate of 31 percent in patients older than 60 with previously untreated AML and high-risk myelodysplastic syndromes who received Cloretazine as a single agent. In a subgroup of 45 elderly patients with de novo AML, the response rate was 49 percent.

• Ziopharm Oncology Inc., of New York, said ZIO-101, a form of organic arsenic, was administered to the first patient in Phase I/II trial in advanced myeloma. Interim data from an ongoing Phase I trial suggested that the drug can be given at significantly higher doses, with no significant toxicity, compared to arsenic trioxide, an inorganic form approved to treat acute promyelogenous leukemia. The ongoing Phase I study is in cohort five, with dosing about 45 times higher than the approved dose of arsenic trioxide.

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