• Ascentia Biomedical Corp., of Bellevue, Wash., received an initial commitment for up to $1 million in funding for continued research, particularly in cancer compounds, and for organizational growth. The financing will come in the form of a series of separate convertible notes through Winsted Holdings Inc., of Newport Beach, Calif.

• Biomira Inc., of Edmonton, Alberta, selected PRA International, of Reston, Va., as the clinical research organization to conduct its Phase III trial of BLP25 Liposome Vaccine for the treatment of non-small-cell lung cancer. The trial design is being discussed with the FDA, and is expected to begin by the end of the year.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., signed a Material Transfer and Option Agreement with an undisclosed European pharmaceutical company to license BioSante's calcium phosphate nanotechnology in the development of allergy products to treat rhinitis, asthma, conjunctivitis, dermatitis and allergic gastrointestinal diseases. BioSante will receive a $250,000 up-front open option payment. If the option is exercised and the parties enter an exclusive license agreement, BioSante would receive a one-time license fee, annual maintenance payments, milestone payments and royalties on commercial sales.

• ChemDiv Inc., of San Diego, entered a minimum two-year medicinal chemistry research partnership with Schering AG, of Berlin. The collaboration has an extension clause dependent upon meeting defined milestones under the contract. ChemDiv will supply its small-molecule chemistry programs; Schering will have access to a range of services including chemistry development, synthesis of hit and lead series, as well as scale-up of production of advanced intermediates.

• Computer Sciences Corp., of El Segundo, Calif., said its DVC LLC division received fast-track designation status from the FDA for three biodefense vaccine development programs it is working on for the Department of Defense Joint Vaccine Acquisition Program Product Management Office.

• Cyclacel Group plc, of Dundee, Scotland, agreed to grant an exclusive option to Cambridge, Mass.-based Genzyme Corp. to license two of Cyclacel's preclinical Cyclin-Dependent Kinase inhibitors for further development in renal diseases and certain related conditions. During the option period, the companies could pursue a collaboration and license agreement for development and commercialization of the compounds. Financial terms were not disclosed.

• Dendreon Corp., of Seattle, plans to submit a biologics license application for Provenge in prostate cancer. The decision follows a recent pre-BLA meeting with the FDA, during which the company reviewed safety and efficacy data from two Phase III trials in patients with advanced prostate cancer. Though both trials missed their primary endpoints of time to disease progression, discussions with the FDA determined that the survival benefit seen in the D9901 study, plus supportive data from the D9902A trial, is sufficient to serve as the clinical basis for a BLA submission. Dendreon reported in July that an analysis of the combined data showed a statistically significant survival benefit of 23 percent over placebo in the 225-patient population. The company also has maintained that the time-to-disease-progression evaluation is unrealistic for an immunotherapeutic, which takes eight to 10 weeks of treatment to activate the immune system. Provenge is designed to stimulate the immune system to attack cells that express prostatic acid phosphatase, a protein found on about 95 percent of prostate cancer cells. Dendreon's shares (NASDAQ:DNDN) gained 79 cents Wednesday, or 12.7 percent, to close at $7.02. (See BioWorld Today, July 22, 2005.)

• Encysive Pharmaceuticals Inc., of Houston, reported interim, top-line results from its ongoing STRIDE-2X study evaluating Thelin (sitaxsentan sodium) and bosentan in patients with pulmonary arterial hypertension. The 229-patient extension study found that the mean exposure time for patients treated with Thelin (43 weeks) exceeded that of patients treated with bosentan (35 weeks), due to a higher discontinuation rate in the bosentan arm. Median changes from baseline in six-minute walk were similar for both groups, but clinical worsening was seen in 20 percent of the Thelin arm and in 30 percent of patients receiving bosentan. Encysive submitted a new drug application for Thelin in May. (See BioWorld Today, May 26, 2005.)

• Epitome Biosystems, of Waltham, Mass., signed a licensing and development agreement with EMD Biosciences Inc., a unit of Darmstadt, Germany-based Merck KGaA, for products based on Epitome's EpiTag technology. Epitome will develop reagents for the quantitative measurement of key intracellular signaling proteins. It will receive a technology access fee, and could get milestone payments and royalties, while EMD Biosciences would market and sell the products for research applications worldwide.

• Galapagos NV, of Mechelen, Belgium, formed a collaboration with Amsterdam Molecular Therapeutics BV in the Netherlands, the Netherlands Institute for Brain Research and the Vrije Universiteit Amsterdam to develop treatments for acute spinal cord and peripheral nerve damage. The collaboration will be funded by a €2 million (US$2.5 million) grant from the Dutch governmental organization Senter. The project will focus on developing therapeutics to promote nerve regeneration and to diminish the effect of neural scarring.

• GangaGen Life Sciences Inc., of Ottawa, Ontario, signed an agreement with Elanco Animal Health, a division of Indianapolis-based Eli Lilly and Co., to develop anti-bacterial products derived from bacteriophages, or phages. The parties intend to jointly develop and commercialize phage-based products for the control of bacteria. Financial terms were not disclosed.

• Genentech Inc., of South San Francisco, found a significant reduction in the risk of reoccurrence in women with early stage breast cancer in its Phase III trial of Herceptin when combined with chemotherapy. Genentech said its study differs from other presented at an American Society of Clinical Oncology meeting earlier this year, in that the study included a regimen of Herceptin plus chemotherapy, enrolled both node-positive and node-negative patients, included Taxotere and determined patients' human epidermal growth factor receptor 2 profile by fluorescent in situ hybridization testing. Genentech expects to file a supplemental biologics license application for Herceptin in early 2006.

• Generex Biotechnology Corp., of Toronto, reported clinical trial results at the 41st annual meeting of the European Association for the Study of Diabetes held in Athens, Greece, this week. The study compared Humulin to Generex's Oral-lyn in 10 Type I diabetic subjects receiving baseline glargine insulin therapy. The study found that Humulin and Oral-lyn, an insulin spray, induced similar glucodynamic responses during the 12-week observation period.

• GTx Inc., of Memphis, Tenn., received a response letter from the FDA's Division of Oncology Drug Products related to a special protocol assessment, and said it agrees to implement the agency's recommendations for its pivotal Phase III trial of Acapodene for the prevention of prostate cancer in high-risk men. The study will evaluate an oral 20-mg dose of Acapodene vs. placebo in 1,260 patients with high-grade prostatic intraepithelial neoplasia, a premalignant lesion of the prostate. The primary endpoint is a reduction in prostate cancer incidence, as determined by a biopsy. Enrollment of the trial began earlier this year. (See BioWorld Today, Jan. 27, 2005.)

• Invitrogen Corp., of Carlsbad, Calif., entered a collaborative research program with the Fred Hutchinson Cancer Research Center in Seattle. Invitrogen will use its human proteome and proteomics-based approaches with investigations by the lab of Sam Hanash, of the Hutchinson Center. Invitrogren's flagship product is ProtoArray, a functional microarray used to measure protein interactions.

• Isotechnika Inc., of Edmonton, Alberta, announced a 90 percent participation level in its Canadian Phase III extension trial for its lead drug, ISA247, for the treatment of psoriasis. Patients who continued therapy for an additional 36 weeks are receiving oral ISA247 capsules at 0.3 mg/kg twice daily.

• LAM Pharmaceuticals Corp., of Lewistown, N.Y., received regulatory approval to market and sell its LAM IPM Wound Gel in the Republic of Panama. Montreal-based aQva Pharmaceuticals, which has a subsidiary in Mexico City and distribution partners in several Latin American countries, will distribute the product.

• Medicure Inc., of Winnipeg, Manitoba, found its MC-4232, a combination of MC-1 and ACE inhibitor lisinopril used to treat co-existing diabetes and hypertension, met primary blood pressure and metabolic endpoints in the Phase II study. The study evaluated MC-4232 in the treating co-existing diabetes and hypertension. Based on the results, the company plans to move to a Phase III program for MC-4232. Medicure's stock (AMEX:MCU) rose 18 cents Wednesday, or 23.4 percent, to close at 95 cents.

• MultiCell Technologies Inc., of Lincoln, R.I., an adult stem cell company and a supplier of immortalized non-tumorigenic human hepatocytes for drug discovery applications, was awarded a pilot grant for a study for Type I diabetes using its immunoglobin therapeutic.

• Neurochem Inc., of Laval, Quebec, launched its European Phase III trial of Alzhemed for the treatment of Alzheimer's disease, following an investigators' meeting in Vienna, Austria, over the weekend. The 930-patient trial will evaluate the safety and efficacy of the disease-modifying drug for a period of 18 months in combination with regular treatment of acetylcholinesterase inhibitors. In July, the company finished enrolling 1,052 mild to moderate AD patients for its North American Phase III trial, and, to date, about 472 and 210 patients have completed six and nine months of treatment, respectively.

• Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., said a recent review of overall safety data from an ongoing Phase II study of NX-1207 revealed no serious drug side effects or safety issues. The pivotal trial is expected to be completed later this year. NX-1207 is being developed as a first-line treatment for benign prostatic hyperplasia.

• Onyx Pharmaceuticals Inc., of Emeryville, Calif., and Bayer Pharmaceuticals Corp., of West Haven, Conn., said the FDA has accepted and granted priority review to the new drug application for sorafenib in advanced renal-cell carcinoma. Priority designation calls for the agency to take action on the application within six months of its receipt. The companies completed the NDA submission in July. (See BioWorld Today, July 12, 2005.)

• Pfizer Inc., of New York, completed its acquisition of King of Prussia, Pa.-based Vicuron Pharmaceuticals Inc., and Vicuron's shares were delisted from Nasdaq and Italy's Nuovo Mercato stock exchanges. Both companies agreed to the purchase, which adds two new product candidates - anidulafungin for fungal infections and dalbavancin for Gram-positive infections, both under FDA review - to Pfizer's pipeline, in exchange for about $1.9 billion. (See BioWorld Today, June 17, 2005.)

• RheoGene Inc., of Norristown, Pa., granted a license to Xenogen Biosciences Corp., of Alameda, Calif., to use RheoGene's RheoSwitch system to develop and distribute RheoMice transgenics as animal research models. The companies also will collaborate on several projects aimed at controlling delivery and regulating expression of RNAi to address the problems of timing and localization of active RNAi products to various target sites in vivo. Financial terms were not disclosed.

• Sangamo BioSciences Inc., of Richmond, Calif., expanded for the second time its research collaboration with LifeScan Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, to use Sangamo's zinc finger DNA-binding proteins to develop therapeutic cell lines to treat diabetes. Sangamo will receive expanded research funding from LifeScan through 2006.

• Sequenom Inc., of San Diego, is cutting nearly 30 percent of its work force - about 44 employees - and consolidating some executive positions to help reduce its cash burn in 2006 by $7 million to $9 million. The company expects a pre-tax charge of about $1 million related to severance and other costs during the third quarter. Sequenom also negotiated a rent deferral of $3.2 million over two years for its San Diego headquarters. The cuts are aimed at focusing the company's efforts on the growth of its core genetic analysis business, while leveraging its MassARRAY technology and intellectual property. Shares of Sequenom (NASDAQ:SQNM) gained 2 cents Wednesday to close at 89 cents.

• Synta Pharmaceuticals Corp., of Lexington, Mass., initiated a multinational, multicenter, randomized, placebo-controlled Phase IIb trial examining the efficacy and safety of STA-5326 in patients with active Crohn's disease. STA-5326 is the first and only oral, small-molecule, selective inhibitor of the interleukin cytokine family, including interleukin-12 and IL-23.

• Unigene Laboratories Inc., of Fairfield, N.J., received a $4 million milestone payment from Upsher-Smith Laboratories Inc., of Plymouth, Minn., for receiving FDA approval for Fortical, its nasal calcitonin product for the treatment of postmenopausal osteoporosis. It is the final milestone payment in Unigene's exclusive U.S. licensing agreement with Upsher-Smith. Fortical was approved and launched last month. (See BioWorld Today, Aug. 16, 2005.)

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