• CuraGen Corp., of Branford, Conn., and TopoTarget A/S, of Copenhagen, Denmark, reported encouraging preliminary results from three clinical trials of intravenous PXD101. Phase Ib data showed two partial objective responses in patients with advanced, refractory cancer and stable disease in three other patients lasting greater than 10 cycles of treatment in a study of PXD101 in combination with paclitaxel and carboplatin. Phase II results showed nine patients receiving PXD101 monotherapy achieved stable disease, with no objective responses observed, and in combination with dexamethasone, there was one partial response, two minimal responses and five patients with stable disease. In a Phase Ib/II combination trial, 5-FU 250mg/m2/day was well tolerated with 1000 mg/m2/d PXD101, and additional cohorts have been added to the trial to evaluate higher doses of 5-FU in combination with PXD101.

• Human Genome Sciences Inc., of Rockville, Md., received a special protocol assessment from the FDA for its Phase III LymphoStat-B (belimumab) program in patients with active systemic lupus erythematosus. Two double-blind, placebo-controlled superiority trials will evaluate the monoclonal antibody's efficacy and safety plus standard of care compared to placebo plus standard of care. The company expects to begin the program before the end of the year. The studies' primary endpoint, patient response rate after a year, is a composite score that includes elements of the SELENA, SLEDAI and BILAG disease activity indices, as well as the Physician's Global Assessment index. Phase II results showed that LymphoStat-B, as measured by this combined response rate, significantly reduced disease activity in serologically active patients, the population in which the drug will be studied in Phase III. (See BioWorld Today, Aug. 10, 2006.)

• Karo Bio AB, of Huddinge, Sweden, received approval from the Swedish Medical Products Agency to begin clinical studies of KB3305, a glucocorticoid antagonist, in diabetes. The company expects to initiate Phase I trials this quarter. Results of those are anticipated in the first quarter.

• MethylGene Inc., of Montreal, and Pharmion Corp., of Boulder, Colo., began a Phase I/II trial evaluating the isotype-specific histone deacetylase (HDAC) inhibitor MGCD0103 in combination with Gemzar (gemcitabine, Eli Lilly and Co.) in patients with solid tumors, including pancreatic cancer. In the Phase I portion, MGCD0103 will be given orally, three times per week for four weeks in combination with Gemzar, which will be administered intravenously once per week for three weeks out of four. Key objectives will be to evaluate the compatibility and safety of administering the two agents together, determining MGCD0103's maximum tolerated dose and defining the Phase II dose. Secondary objectives include determining the dose-limiting toxicities, objective responses, time to progression, survival, and the pharmacodynamic and pharmacokinetic characteristics. In the expanded Phase II portion, the primary objective is to determine the overall response rate in pancreatic cancer patients. The trial may enroll up to 60 patients and is expected to take 18 to 24 months.

• Reata Pharmaceuticals Inc., of Dallas, said the FDA granted orphan drug designation for RTA 744 in malignant gliomas, which would allow for seven years of marketing exclusivity upon approval. RTA 744 is an anthracycline derivative designed to cross the blood-brain barrier to treat primary and metastatic brain cancers, and is in a Phase I trial, with advanced clinical testing expected to begin in 2007.

• Vion Pharmaceuticals Inc., of New Haven, Conn., said Phase II data reported at the Chicago Symposium on Malignancies of the Chest and Head & Neck showed that Cloretazine (VNP40101M) was an effective single agent in patients with relapsed or refractory small-cell lung cancer. Of the evaluable patients in the sensitive relapsed arm, there have been five with partial response and one awaiting confirmation of response, representing an overall 32 percent response rate. Two patients have stable disease. Of those patients with refractory disease treated with Cloretazine, one patient achieved a partial response and three have demonstrated stable disease.

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