• Aastrom Biosciences Inc., of Ann Arbor, Mich., reported additional interim results from its Phase I/II trial testing its Tissue Repair Cells (TRCs) in patients with recalcitrant long bone non-union fractures. Of the 12 patients to complete the one-year follow-up period, 10 of those showed bone bridging at the fracture site, indicating radiographic evidence of healing. In a subset of seven patients, six returned to weight-bearing mobility by six months, and in a subset of eight patients, all returned to weight-bearing mobility by 12 monthS. Those results were presented at the 28th annual meeting of the American Society for Bone and Mineral Research in Philadelphia.

• Affymax Inc., of Palo Alto, Calif., said Phase I data published in the Sept. 15, 2006, issue of Blood demonstrated that single doses of Hematide resulted in dose-dependent increases in circulating reticulocytes in normal healthy volunteers and in a clinically and statistically significant increase in red blood cells and hemoglobin from baseline, which was sustained for at least one month. The company's first product candidate to enter clinical testing, Hematide is a peptide-based drug designed to stimulate the production of red blood cells. It is in Phase II trials for anemia associated with chronic kidney disease and in anemic cancer patients undergoing chemotherapy.

• Array BioPharma Inc., of Boulder, Colo., received a $3 million payment from AstraZeneca plc, of London, for achieving a Phase II milestone with AZD6244 (also known as ARRY-142886). The payment was triggered upon dosing the first patient in a Phase II trial. AZD6244 is a selective MEK inhibitor in testing against melanoma that was in-licensed by AstraZeneca from Array in December 2003. (See BioWorld Today, Dec. 19, 2003.)

• Clinical Data Inc., of Newton, Mass., said its PGxHealth Division signed a pharmacogenomics testing agreement with PharmaCare Management Services Inc., a wholly owned subsidiary of CVS Corp., to provide pharmacogenomics testing services and to assist in the incorporation of genetic testing into PharmaCare clinical programs. Initially, PGxHealth tests associated with clozapine and warfarin will be the focus of the collaboration, and both parties will work to introduce those and other tests to PharmaCare customers as they become available. Financial terms of the deal were not disclosed.

• Critical Therapeutics Inc., of Lexington, Mass., said results of a Phase II trial showed no signal or positive efficacy trends between its anti-inflammatory compound, CTI-01, and placebo in patients at risk of serious complications, including organ damage, while undergoing major cardiac surgery involving the use of the cardiopulmonary bypass machine. The primary efficacy endpoint was a composite endpoint measured as a reduction in major complications with 14 and 28 days of surgery. In March, the company discontinued the trial due to a manufacturing issue related to the drug container closure system, and following news of the study results, said it plans to assess whether there is an opportunity to continue developing CTI-01 with a partner or to out-license the product. (See BioWorld Today, March 16, 2006.)

• Genta Inc., of Berkeley Heights, N.J., said long-term data from its Phase III trial of Genasense (oblimersen sodium) injection in 771 patients with advanced melanoma showed an overall response rate of 13.5 percent in patients who received Genasense in combination with dacarbazine vs. 7.5 percent in the dacarbazine-only arm. Median progression-free survival was 2.6 months for patients receiving the combination therapy compared to 1.6 months for patients receiving only dacarbazine. Those results were published in the Journal of Clinical Oncology.

• Marshall Edwards Inc., of Washington, said data reported at the International Conference on Molecular Diagnostics in Cancer Therapeutics in Chicago indicated that phenoxodiol might be effective in treating prostate cancer through its ability to target a protein that appears to be selective for prostate cancer cells, tNOX 75 alpha, which is critical to the ability of the tumor cell to grow and survive. In a study of 19 patients, all had tNOX 75 alpha in their bloodstream prior to receiving the investigational drug, and subsequent blood analysis revealed that levels of the protein responded to phenoxodiol in 11 of them.

• MethylGene Inc., of Montreal, and Pharmion Corp., of Boulder, Colo., initiated a Phase II trial of MGCD0103, a histone deacetylase (HDAC) inhibitor, in patients with relapsed or refractory B-cell lymphoma. The 24-month study will enroll up to 82 patients with diffuse large B-cell lymphoma and follicular lymphoma for whom other treatments have failed or whose disease has relapsed. Key objectives are to evaluate the effectiveness of the drug, while secondary objectives include determining MGCD0103's safety profile and assessing biomarkers and predictive markers.

• Schering AG, of Berlin, and AstraZeneca plc, of London, formed an alliance to co-develop and jointly commercialize Schering AG's novel selective estrogen receptor down-regulator. The companies will jointly develop the novel SERD with AstraZeneca leading the clinical development and Schering leading the nonclinical and process development, as well as manufacturing activities. The companies will co-promote the product in major territories. All development and commercialization costs and global profits will be shared equally. Financial terms were not disclosed.

• SciClone Pharmaceuticals Inc., of San Mateo, Calif., reported Phase I data indicating that oral SCV-07 was safe and led to circulating plasma concentrations similar to those obtained in previous Phase I studies using a subcutaneous injection of the investigational drug. Notably, oral SCV-07 resulted in only 10 percent plasma level variability between all volunteers in this latest study, demonstrating highly predictable plasma concentrations after oral dosing of this drug, the company said.

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