• Abraxis BioScience Inc., of Los Angeles, said it received tentative approval from the FDA for its abbreviated new drug application for fosphenytoin sodium injection vials, a generic equivalent to New York-based Pfizer Inc.'s Cerebyx. Abraxis said it expects to receive final approval and begin marketing the product upon patent expiration. Fosphenytoin sodium injection can be used for the control of generalized convulsive status epilepticus and prevention and treatment of seizures occurring during neurosurgery. It also can be a short-term substitute for oral phenytoin.

• Addex Pharmaceuticals SA, of Geneva, said it successfully completed a Phase IIa proof-of-concept trial with its lead compound, ADX10059, in patients with migraine. The 129-patient study in Europe achieved its primary objective, the absence of pain at two hours after dosing, with statistical significance, and also showed trends toward improvement in pain-free status and improvement of migraine pain at other time points. ADX10059 recently demonstrated a potential therapeutic benefit in a Phase IIa study in gastroesophageal reflux disease, and is completing a Phase IIa study in anxiety. ADX10059 is a selective, negative allosteric modulator of metabotropic glutamate receptor 5.

• Aeolus Pharmaceuticals Inc., of Laguna Niguel, Calif., said research showed that one of its metalloporphyrin antioxidants, AEOL 10113, accelerates the recovery of blood cellular components derived from the stem cells. AEOL 10113 was studied to determine its ability to modify radiation-induced effects on bone marrow-derived cells, and researchers observed greater increases in DNA synthesis in samples of whole blood taken four days after radiation explore, with the greatest increase occurring in animals that received the compound 12 hours and 24 hours after radiation exposure. Data were presented at the American Association for Cancer Research meeting in Los Angeles.

• AVEO Pharmaceuticals Inc., of Cambridge, Mass., said findings from its human-in-mouse tissue transgenic cancer model system successfully created invasive human tumors that develop over time in mice from primary human breast tissue. The model is designed to enable scientists to generate and study in vivo human tumor initiation, progression and treatment in a preclinical model. Those models are part of the company's Human Response Prediction platform, which was developed to define genetic context in which to validate cancer gene candidates, determine their biological roles in various stages of cancer progression and test targeted therapies directed against specific genetic lesions.

• AVI BioPharma Inc., of Portland, Ore., said it closed on the purchase of a building in Corvallis, Ore. The 34,000-square-foot facility will house additional capability for the large-scale GMP production of AVI's phosphorodiamidate morpholino oligomers (PMOs), and for the recovery and purification of PMO precursors. Additional capacity for those processes is needed to meet the anticipated bulk drug supply requirements for AVI and its partners. The purchase price of the facility was $3.3 million, including a down payment of about $1.1 million in AVI stock and cash, and the assumption of an existing mortgage.

• Cleveland BioLabs Inc., of Cleveland, said Protectan CBLB612 was found to be highly efficacious in stimulating proliferation and mobilization of hematopoietic stem cells into peripheral blood in a study in Rhesus macaques. CBLB612 is the lead compound in the Protectans 600 series, a class of modified factors of mycoplasmas that demonstrated both radiation protection and mitigation properties over a broad time window. A single injection of CBLB612 in the primate model resulted in a 20-fold increase of hematopoietic progenitor cells in blood. At the peak of the effect (48 to 72 hours post-injection), the proportion of free-floating CD34+ cells in the total white blood cell count reached 30 percent (compared with 1.5 percent in normal blood).

• Diazyme Laboratories, of San Diego, said the FDA granted Diazyme 510(k) clearance to market its Direct Enzymatic Hemoglobin A1c (HbA1c) Assay Kit for the quantitative determination of HbA1c in human whole blood samples. HbA1c testing is used to monitor patient glycemic status.

• Enzon Pharmaceuticals Inc., of Bridgewater, N.J., said the FDA granted full approval to DepoCyt (cytarabine liposome injection) for the treatment of patients with lymphomatous meningitis, a life-threatening complication of lymphoma. DepoCyt originally was approved under an accelerated process. Full approval was based on findings from two randomized, controlled trials that included more than 200 patients with neoplastic meningitis related to solid tumors, lymphoma or leukemia. The first study demonstrated that more patients with lymphomatous meningitis treated with DepoCyt showed an absence of neurological progression of the disease. The second study showed an increase in complete cytologic responses among DepoCyt patients, as defined by a clearing of malignant cells in the cerebrospinal fluid. The product has been on the market since 1999.

• Nabi Biopharmaceuticals, of Boca Raton, Fla., entered a definitive agreement to sell its Aloprim (allopurinol sodium) for injection product to Bioniche Teoranta, a County Galway, Ireland-based unit of the Bioniche Pharma Group. Nabi will receive $3.7 million in the deal: $1.3 million at closing, $1.4 million at the end of 2007 and $1 million at the end of 2008. Nabi recently disclosed plans to form two strategic business units - Nabi Biologics and Nabi Pharmaceuticals - and said Aloprim no longer was a strategic component of its portfolio. Aloprim is an injectable agent approved to manage cancer in those receiving therapy that causes elevations of serum and urinary uric acid levels (and who cannot tolerate oral therapy).

• PTC Therapeutics Inc., of South Plainfield, N.J., said it withdrew its S-1 registration statement for a proposed initial public offering. The company registered for an IPO of up to $88.25 million in March 2006. It said since then it has "enjoyed significant business development successes" that have put it in a strong financial position, with sufficient capital to meets it planned needs. It said another reason to postpone the IPO is that clinical trial results are expected within the next six months. PTC is developing small-molecule drugs that target post-transcriptional control processes, which regulate protein production. It also has technologies in that area, including the Gene Expression Modulation by Small-Molecules platform.

• Rosetta Genomics Ltd., of Rehovot, Israel, presented updated results on its lead diagnostic development program for cancer of unknown primary (CUP), at the American Association for Cancer Research meeting in Los Angeles. It presented information on the expansion of its CUP assay to include 15 major cancer types, identifiable through a unique signature of 19 microRNAs with 85 percent accuracy. In addition, it presented data on its methods for extraction and profiling of microRNAs.

• Shire plc, of Basingstoke, UK, completed its acquisition of New River Pharmaceuticals Inc., of Radford, Va. Shire previously announced the acquisition of 96.4 percent of New River's stock pursuant to a cash tender offer. Shire paid $64 in cash per New River Share, or about $2.6 billion. (See BioWorld Today, Feb. 21, 2007.)

• SuperGen Inc., of Dublin, Calif., signed a definitive agreement to sell the rights to the anticancer agents mitomycin and paclitaxel to Intas Pharmaceuticals Ltd., of Ahmedabad, India, for $1.2 million. SuperGen also will sell for additional consideration certain related inventory. Both products were part of SuperGen's initial corporate strategy to move into the commercial oncology market through generic products and then transition into propriety markets as products were approved. Additional non-core assets may be divested later this year, it said.

No Comments