• Aastrom Biosciences Inc., of Ann Arbor, Mich., said that 90 percent of patients who have completed the 12 months post-treatment follow-up a Phase I/II trial evaluating the use of Tissue Repair Cells in the treatment of severe long bone fractures had multiple bone bridges, evidence of bone regeneration. Twenty of 36 patients in the trial had completed 12-month follow-up. TRCs are a mixture of stem and progenitor cells derived from the patient's bone marrow.

• ChemGenex Pharmaceuticals Ltd., of Melbourne, Australia, reported positive results from a Phase I/II study supporting the development of Ceflatonin in patients with chronic myeloid leukemia, including those who have failed treatment with Gleevec (imatinib mesylate). Of the five patients who received Ceflatonin (homoharringtonine) at the highest explored dose and were evaluable for response to therapy, all achieved a complete hematological response, including those with the Bcr-Abl kinase domain mutations that confer Gleevec resistance. Those results were published in Cancer.

• Genta Inc., of Berkeley Heights, N.J., said findings from a Phase III trial of Genasense (oblimersen sodium) injection in relapsed or refractory chronic lymphocytic leukemia achieved its primary endpoint, which was defined as a statistically significant increase in the proportion of patients receiving Genasense with fludarabine plus cyclophosphamide chemotherapy who achieved a complete or nodular partial response (17 percent) over those receiving chemotherapy alone (7 percent.) Those findings were published on-line in the Journal of Clinical Oncology. The FDA issued a non-approvable letter for Genasense in CLL in December, though Genta said earlier this month that it intends to appeal the agency's decision. (See BioWorld Today, Dec. 18, 2006.)

• Infinity Pharmaceuticals Inc., of Cambridge, Mass., and MedImmune Inc., of Gaithersburg, Md., initiated a Phase I/II trial of IPI-504, a heat-shock protein inhibitor, in patients with advanced non-small-cell lung cancer. The Phase I portion will evaluate safety and determine the maximum tolerated dose and the Phase II portion will test antitumor activity of twice-weekly intravenous infusions of IPI-504 in NSCLC patients with or without epidermal growth factor receptor mutations. Biological activity will be measured using both CT scans and positron emission tomography imaging.

• IsoTis Inc., of Irvine, Calif., said it received a letter from the FDA regarding its pending 510(k) application for its Accell products. The letter questioned whether the Accell products should be regulated as a medical device. Moreover, if regulated as a medical device, the letter questioned whether the Accell products are Class II or Class III devices. IsoTis is requesting a meeting with the FDA to discuss the questions. In light of that news, the company decided not to proceed with a proposed public offering of stock, and withdrew a registration statement filed Jan. 29.

• Light Sciences Oncology Inc., of Seattle, treated the first patient in its Phase II trial of its Light Infusion Therapy (Litx) in glioma. The study is expected to enroll a total of 12 patients, with the primary objective of demonstrating the product's safety with increasing light doses. Litx uses light-emitting diodes to activate LS11 (talaporfin sodium), which aims to produce singlet oxygen molecules that can kill target tissues with minimal side effects through vascular closure and apoptosis.

• Pharmacopeia Drug Discovery Inc., of Princeton, initiated a Phase I study to evaluate PS433540, its lead internal product candidate, in up to seven groups of healthy volunteers. In addition to safety and tolerability, the trial will also assess dose-related pharmacokinetics. PS433540 is a dual-acting angiotensin and endothelin receptor antagonist (DARA) in development for hypertension and diabetic nephropathy.