• Arpida Ltd., of Basel, Switzerland, completed a Phase I trial with oral iclaprim in a capsule formulation designed to assess its bioavailability compared to the intravenous formulation. Results show bioavailability of around 40 percent, and confirm that oral administration can achieve blood levels comparable with those of I.V. iclaprim. A further trial to determine the maximum tolerated dose is ongoing.

• CytRx Corp., of Los Angeles, enrolled the first patient in an open-label extension trial of its lead small molecule, arimoclomol, for amyotrophic lateral sclerosis (ALS). A year ago, the company filed a protocol with the FDA to allow ALS patients who have completed its Phase IIa trial to receive treatment with orally administered arimoclomol at the highest of the three dose levels for up to an additional six months. The extension is designed to provide additional safety and tolerability data in combination with the current 80-patient Phase IIa trial, which is on track to complete enrollment this quarter. Arimoclomol has orphan drug status and fast-track designation from the FDA.

• EPIX Pharmaceuticals Inc., of Cambridge, Mass., said it completed proof-of-concept studies for its anticoagulant therapeutic program and intends to pursue the licensing of the technology to a larger company for further development. For the tests, EPIX used a molecule derived from its technology, and attached it to the direct thrombin inhibitor melagatran, the active form of Exanta.

• Morphotek Inc., of Exton, Pa., said the FDA cleared its investigational new drug application for MORAb-009 for mesothelin-expressing cancers. Research has shown that the product can inhibit tumor growth by inhibiting mesothelin binding to extracellular substrate and through antibody-dependent cellular cytotoxicity. MORAb-009 initially will be developed for treating patients with advanced pancreatic cancer.

• Myogen Inc., of Denver, said top-line results from the open-label AMB-222 study showed that none of its 36 pulmonary arterial hypertension patients had a recurrence of liver function abnormalities that resulted in discontinuation of ambrisentan during the initial 12-week evaluation period, its primary endpoint. The trial tested ambrisentan in patients who previously have discontinued bosentan and/or sitaxsentan treatment due to liver function abnormalities. One patient had a transient serum aminotransferase test result greater than three times the upper limit of the normal range (3xULN) at week 12, resulting in a dose reduction from 5 mg to 2.5 mg ambrisentan, but the patient remains on ambrisentan therapy and has not had a recurrence of serum aminotransferases greater than 3xULN. Patients have continued to receive ambrisentan therapy for periods up to nine months and no further occurrence of serum aminotransferase concentrations greater than 3xULN has been observed.

• Neose Technologies Inc., of Horsham, Pa., began dosing healthy volunteers in a Phase I trial of NE-180, its long-acting GlycoPEGylated erythropoietin for the treatment of anemia. The trial is designed to evaluate both subcutaneous and intravenous administrations of the drug. If results show the drug is safe and well tolerated, the company expects to initiate a Phase IIa trial during the second half of 2006.

• Prestwick Pharmaceuticals Inc., of Washington, said findings published in the Feb. 14, 2006, issue of Neurology showed that tetrabenazine cut down involuntary movement of Huntington’s disease patients on average by about 25 percent, with many patients experiencing a greater improvement. Overall, patients who received the medication were six times as likely to be considered by their doctors to have improved considerably, compared to participants who received a placebo. Tetrabenazine, which is approved in Europe and Canada, is under FDA review.

• ProMetic BioSciences Inc., of Montreal, received authorization from the Therapeutic Products Directorate of Health Canada to begin a Phase Ib/II trial of PBI-1402, a compound in development for anemia. The study will test the drug’s safety and efficacy in up to 30 cancer patients undergoing chemotherapy and suffering from anemia.

• Valentis Inc., of Burlingame, Calif., completed dosing in its Phase IIb trial of VLTS 934 for peripheral arterial disease. Efficacy results from the 140-patient, randomized, double-blinded, placebo-controlled study are expected in July. The primary endpoint of the trial, which began a year ago, is improvement in exercise tolerance 90 days after treatment. VLTS 934, a nonionic block copolymer known as a poloxamer, appears to have a direct effect of repairing compromised cell membranes and improving cell function, which may have a therapeutic benefit in ischemic tissue.

• YM BioSciences Inc., of Mississauga, Ontario, said the FDA named tesmilifene a fast-track product for use in combination with an anthracycline chemotherapeutic to treat women with advanced breast cancer. While the company is seeking clarification on certain aspects of the letter, it confirmed that the small molecule meets the criteria for fast-track designation in metastatic/recurrent breast cancer. The company’s lead drug, it has completed enrollment in a 700-patient pivotal Phase III trial in metastatic and recurrent breast cancer.

No Comments