• Adherex Technologies Inc., of Research Triangle Park, N.C., initiated a Phase I trial of ADH-1 in combination with chemotherapy in conjunction with the U.S. Oncology Research network. The study, expected to involve up to 55 patients with N-cadherin positive solid tumors, is designed to define the dose-limiting toxicities and maximum tolerated dose of ADH-1 in three separate combinations - with docetaxel, with carboplatin, or with capecitabine. ADH-1 also is being tested as a single agent in two ongoing Phase II trials in patients with tumors expressing N-cadherin, and expects to complete enrollment in those by the end of 2006.

• AEterna Zentaris Inc., of Quebec City, disclosed statistically significant positive data from its Phase II trial of ozarelix in benign prostatic hyperplasia. The 144-patient study, conducted in collaboration with partner, Irvine, Calif.-based Spectrum Pharmaceuticals Inc., achieved its primary endpoint of improving clinical symptoms of BPH at week 12, as measured by significant changes in the International Prostate Symptom Score (I-PSS). Patients were randomized to receive either different intramuscular dosage regimens of ozarelix, a luteinizing hormone-releasing hormone antagonist, or placebo. The endpoint was reached at all dosages, and a mean decrease of the I-PSS score at week 28 was at minus 8.7, representing a 47 percent mean improvement vs. placebo.

• Allos Therapeutics Inc., of Westminster, Colo., said the FDA granted fast-track designation to its next-generation antifolate PDX (pralatrexate) for T-cell lymphoma. That designation allows the submission of new drug applications on a rolling basis, and ordinarily qualifies for priority review to expedite the regulatory process. PDX, a small-molecule chemotherapeutic agent designed to inhibit dihydrofolate reductase, started a pivotal Phase II trial in August that is seeking to enroll 100 patients with relapsed or refractory PTCL who have progressed after at least one prior treatment. (See BioWorld Today, Aug. 3, 2006.)

• EpiCept Corp., of Englewood Cliffs, N.J., submitted an investigational new drug application to begin Phase I studies of EPC2407 in cancer patients. The objective of the first trial, expected to enroll about 30 to 40 patients, will be to determine the maximum tolerated dose, characterize the blood levels and biological effects of the drug, and identify any antitumor response as measured by CT scans, MRI or PET scans. EPC2407, a small-molecule microtubulin inhibitor, is designed to induce apoptosis and disruption of tumor blood flow and is intended to treat advanced cancer patients with solid tumors that are well vascularized.

• Plexxikon Inc., of Berkeley, Calif., submitted an investigational new drug application for its lead oncology compound, PLX4032, a B-Raf inhibitor aimed at a mutation found in 70 percent of malignant melanomas and a significant number of colorectal and thyroid tumors. The company said it will use a new test to detect the presence of the cancer-causing gene to identify patients most likely to respond to PLX4032. A Phase I trial is anticipated to start by the end of the year.

• Sequella Inc., of Rockville, Md., initiated a Phase I trial of SQ109, its lead product for tuberculosis. The study, expected to run for three to four months, will enroll 46 healthy volunteers to be divided into dose groups of eight, plus an additional group of six in an effect of food group, to evaluate the safety and pharmacokinetics of the drug. SQ109 is designed to inhibit cell wall synthesis in a select group of microorganisms and has shown in vitro activity against both drug-susceptible and drug-resistant TB bacteria, including XDR-TB.

• Ziopharm Oncology Inc., of New York, reported results from an ongoing Phase I trial of ZIO-101, an organic arsenic, in solid tumors, which showed that of the 29 subjects receiving the drug, eight have benefited. Seven of those have stable disease, including three with colorectal cancer, two with renal-cell cancer, one with head and neck cancer and one with a spinal cord tumor. An eighth patient with pancreatic cancer had a substantial decrease of a liver metastasis. Data were presented at the European Society of Medical Oncology meeting in Istanbul, Turkey.

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