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Other News To Note
(BioWorld Today Via Acquire Media NewsEdge) , of Los Angeles, has received approval from the China State Food and Drug Administration to market Abraxane Paclitaxel for Injection (Albumin Bound) for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Phase III trials in the U.S. and China on which the approval was based demonstrated that Abraxane doubled the response rate, significantly prolonged time to tumor progression, and in the U.S. trial, significantly improved overall survival vs. Taxol in the approved indication.
? Alcon Inc., of Huenenberg, Switzerland, has terminated the development program designed to evaluate the benefit of anecortave acetate treatment on the risk for developing sight-threatening choroidal neovascularization secondary to age-related macular degeneration. The decision followed a planned interim analysis of studies C-02-60 A and B that was performed after 2,546 patients had completed the 24-month time point. In the analysis, anecortave acetate showed no effect on the primary or secondary endpoints. In addition to terminating studies C-02-60 A and B, the company also terminated two smaller studies with an identical design that were being conducted in Asia, C-04-30 and C-05-34. The company continues to study anecortave acetate administered as an anterior juxtascleral depot to reduce intraocular pressure in patients with open-angle glaucoma.
? Alkermes Inc., of Cambridge, Mass., said preclinical results demonstrated that naltrexone for extended-release injectable suspension was more effective in an animal model of substance abuse compared to oral naltrexone therapy. Data showed that treatment of XR-NTX weakened the rewarding effects of amphetamine in the brain for at least two weeks, reducing reward by 70 percent in rodents at day 14, compared to no effect for oral and subcutaneous naltrexone. Data were presented at the Controlled Release Society meeting in New York.
? Biolex Therapeutics Inc., of Pittsboro N.C., and MRC Technology, the London-based translational arm of Great Britain's Medical Research Council, said MRCT completed the humanization of BLX-301, an antibody targeting CD20 for non-Hodgkin's lymphoma and rheumatoid arthritis. Specific financial terms were not disclosed, but Biolex retains all rights to the antibody and MRC will receive milestone and royalty payments.
? CombiMatrix Corp., of Mukileton, Wash., was awarded a 15-month, $922,610 contract from the U.S. Department of Defense. The funding will support development of a hand-held device for detecting toxins, viruses and bacteria.
? Cyclacel Pharmaceuticals Inc., of Berkeley Heights, N.J., said preclinical results showed synergistic activity between its investigational therapy seliciclib and multiple epidermal growth factor receptor (EGFR) inhibitors, including Tarceva (erlotinib) in models of non-small-cell lung cancer and Herceptin (trastuzumab) in models of breast cancer, both marketed by Genentech Inc., of South San Francisco. The results were published in the July 2008 issue of Clinical Cancer Research. Seliciclib, an orally available cyclin-dependent kinase (CDK) inhibitor, currently is being tested as a single agent in the Phase IIb APPRAISE trial in patients with non-small-cell lung cancer and in a Phase II study in patients with nasopharyngeal cancer.
? Genaera Corp., of Plymouth Meeting, Pa., said preclinical data showed that trodusquemine (MSI-1436), a PTP-1B inhibitor in development for Type II diabetes and obesity, enhanced insulin signaling through potent PTP-1B inhibition both in vivo and in vitro. Inhibition of PTP-1B has been shown to reduce food intake, induce weight loss and increase insulin sensitivity in diet-induced and genetically obese animal models. Data were presented at the Biennial FASEB Summer Research Conference Protein Phosphatases meeting in Snowmass Village, Colo.
? Gene Logic Inc., of Gaithersburg, Md., and Agilent Technologies Inc., of Santa Clara, Calif., said Gene Logic was reappointed as a certified microarray service provider for Agilent gene expression microarrays. Financial terms were not disclosed.
? Genentech Inc., of South San Francisco, and the FDA informed health care professionals Monday of reports of several cases of microangiopathic hemolytic anemia in patients with solid tumors receiving Avastin in combination with sunitinib malate. Avastin is not approved for use in combination with sunitinib malate, and the combination is not recommended. The Phase I dose-escalation study combining Avastin and sunitinib malate involved 25 patients and consisted of three cohorts using a fixed dose of Avastin at 10 mg/kg/I.V. every two weeks and escalating doses of sunitinib that included 25, 37.5 and 50 mg orally daily given in a four weeks on, two weeks off schedule. Five of 12 patients at the highest sunitinib dose level exhibited laboratory findings consistent with MAHA. Two of the cases were considered severe with evidence of thrombocytopenia, anemia, reticulocytosis, reductions in serum haptoglobin, schistocytes on peripheral smear, modest increases in serum creatinine levels and severe hypertension, reversible posterior leukoencephalopathy syndrome and proteinuria. The findings in the two cases were reversible within three weeks upon discontinuation of both drugs without additional interventions. Health care professionals were urged to report cases of MAHA or any serious adverse events suspected to be associated with the use of Avastin.
? Hana Biosciences, of South San Francisco, said the European Commission has granted orphan medical product designation to Marqibo (vincristine sulfate injection, Optisome) for the treatment of adult acute lymphoblastic leukemia. The designation was granted based on the recommendation of the European Medicines Evaluation Agency following a positive opinion from the Committee for Orphan Medicinal Products.
? Hemispherx Biopharma Inc., of Philadelphia, resolved all litigation with Bioclones Ltd., of South Africa, and its subsidiary Ribotech Pty Ltd. Bioclones previously licensed the rights to Hemispherx's drug Ampligen in several ex-U.S. territories, and both companies had filed various complaints against one another. The settlement dismisses all litigation by mutual agreement, with Hemispherx regaining all rights to Ampligen, which is under FDA review for chronic fatigue syndrome. (See BioWorld Today, Oct. 12, 2007.)
? Insmed Inc., of Richmond, Va., said it retained RBC Capital Markets to act as its strategic financial advisor. The company plans to examine various strategic alternatives aimed at leveraging its assets in the biopharmaceuticals and follow-on biologics areas.
? Luminex Corp., of Austin, Texas, signed a licensing agreement gaining rights to Rotterdam, the Netherlands-based ViroNovative BV's human metapneumonia virus intellectual property in the xTAG respiratory viral panel. Under the terms, ViroNovative's IP will be extended to Luminex's distributors and end-user customers around the world. Financial details were not disclosed.
? QLT Inc., of Vancouver, British Columbia, said that its U.S. subsidiary completed the sale of Aczone (dapsone) Gel, a topical treatment for acne vulgaris, to Allergan Inc., of Irvine, Calif., for $150 million. The Aczone deal is the second agreement entered into by QLT to divest noncore assets since it announced its strategic restructuring earlier this year. (See BioWorld Today, Jan. 18, 2008, and June 10, 2008.)
? Vermillion Inc., of Fremont, Calif., said it engaged investment bank ThinkPanmure LLC to assist the firm in identifying and evaluating strategic alternatives intended to enhance the potential of the company's proteomic tests and pipeline of biomarkers.
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