• Cougar Biotechnology Inc., of Los Angeles, enrolled the first patient in a Phase I study of CB3304 (noscapine), an oral inhibitor of microtubule dynamics. The compound will be administered daily to patients with relapsed or refractory multiple myeloma. Cougar licensed rights to CB3304 in 2004 from Emory University.

• Crucell NV, of Leiden, the Netherlands, and Aeras Global TB Vaccine Foundation in Rockville, Md., started a Phase I BCG-Ad35 prime-boost trial of an AdVac-based tuberculosis vaccine earlier than expected. The trial will involve about 32 healthy volunteers and will test the immunogenicity and safety of BCG prime, followed by two AERAS-402 boost doses administered at three- to six-month intervals after BCG. Crucell also reported that it will receive up to $5 million from the foundation to support the advanced development of an AdVac- and PER.C6-based tuberculosis vaccine.

• Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, submitted an investigational new drug application for LX1032, an oral drug candidate for managing gastrointestinal symptoms associated with carcinoid syndrome. The company expects to initiate trials following the FDA's review. LX1032's target was identified through the Genome5000 project, Lexicon's program to identify the function of 5,000 druggable genes. The product is being developed through a June collaboration with Symphony Capital Partners LP and co-investors. (See BioWorld Today, June 19, 2007.)

• Memory Pharmaceuticals Corp., of Montvale, N.J., dosed the first subject in a Phase IIa trial of MEM 3454, a nicotinic alpha-7 receptor partial agonist, in cognitive impairment associated with schizophrenia (CIAS). That trial follows the recently completed Phase IIa trial of the drug in Alzheimer's disease, which produced positive findings. Memory anticipates finishing the 160-patient CIAS trial in the fourth quarter of 2008. The primary objective is assessing MEM 3454's effectiveness using the MATRICS Consensus Cognitive Battery, and secondary objectives include measures of other symptoms of schizophrenia and functional capacity.

• Oncolytics Biotech Inc., of Calgary, Alberta, completed patient enrollment in its Phase Ia/Ib trial testing the intratumoral delivery of Reolysin in combination with radiation in advanced cancer patients. A total of 23 patients received a range of two to six doses of the drug at escalating dosages up to 1x10 TCID, with a constant localized radiation dose of either 20 Gy or 36 Gy. The company said treatment appeared to have been well tolerated and it resulted in both local and remote antitumor activity in patients with a variety of advanced cancers.

• Progen Pharmaceuticals Ltd., of Brisbane, Australia, said no eligible patients have been found yet for its Phase III hepatocellular carcinoma study, meaning the company will not meet its original goal of enrolling the first patient by year-end. The firm, however, does not expect that the delay will have any impact on overall study timelines or registration review. Progen is testing PI-88, a multi-targeted cytostatic cancer therapeutic that has received orphan drug designation in Europe and fast-track status in the U.S. The Phase III study will evaluate the drug in about 600 patients with resected liver cancer, with disease-free survival as the primary endpoint.

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