• A.P. Pharma Inc., of Redwood City, Calif., said its Phase II trial of APF530 achieved all clinical endpoints, and the company plans to move the product into pivotal trials next quarter. APF530, which contains the anti-nausea drug granisetron, was formulated with the company's Biochronomer bioerodible drug delivery system and is designed to prevent both acute and delayed chemotherapy-induced nausea and vomiting.

• Amarillo Biosciences, of Amarillo, Texas, will begin enrolling patients in its study of interferon lozenges to treat bone marrow disorders at the M.D. Anderson Cancer Center. The interferon lozenges will be tested in patients with one of two stem cell disorders of the bone marrow, polycythemia vera and essential thrombocythemia. The study is expected to take about one year to complete. Data generated in Russia, China, Japan and Bulgaria indicated that low doses of oral or nasal interferon reduce the severity and duration of influenza. Amarillo expects to test oral interferon in influenza in 2006.

• Ambion Inc., of Austin, Texas, and UK-based GE Healthcare, a unit of General Electric Co., entered a license and supply agreement under which GE Healthcare will manufacture for Ambion microRNA microarrays using its CodeLink Bioarray technology. These microarrays include a panel of known human, mouse and rat miRNAs, as well as Ambion's non-published microRNAs, Ambi-miR.

• Aspreva Pharmaceuticals Corp., of Victoria, British Columbia, and its partner F. Hoffmann-La Roche Ltd., of Basel, Switzerland, concluded the special protocol assessment with the Cardio-Renal Division of the FDA for the Phase III trial of CellCept (mycophenolate mofetil) to treat lupus nephritis. The global study will enroll 358 patients with biopsy-proven lupus. The first patient was treated in July. Results are expected at the end of 2006.

• AVI BioPharma Inc., of Portland, Ore., said a new application of its Neugene antisense technology, called ESPRIT (Exon Skipping Pre-RNA Interference Technology) is designed to either delete disease-causing genetic sequences or skip functional sequences to redesign proteins that are overexpressed or harmful in certain diseases. AVI intends to apply that approach to diseases with an immunologic component, such as diabetes and multiple sclerosis.

• Bioniche Life Sciences, of Belleville, Ontario, reported financial results for fiscal year 2005 ended June 30. At the same time, it announced that the company's board of directors has decided to sell its majority ownership stake in Bioniche Pharma Group Limited, its sterile injectable manufacturing operation in County Galway, Ireland. The Bioniche Pharma business unit was established by Bioniche Life Sciences in 1992 to generate revenue to support the company's strategic research and development projects. Bioniche Life Sciences is focusing on its potential strategic priorities: the Phase III trial with the company's mycobacterial cell wall-DNA complex (MCC) for bladder cancer and the licensing of its E. coli O157:H7 vaccine for cattle.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., said Phase III data of Bio-E-Gel (bio-identical estradiol gel) showed three doses significantly decreased the number of hot flashes in menopausal women and identified the lowest effective dose. The most effective dose significantly decreased the number of hot flashes by 88 percent from 12.9 per day at baseline to 1.6 after treatment. The data were presented at the North American Menopause Society annual meeting in San Diego.

• Cellegy Pharmaceuticals Inc., of Brisbane, Calif., said its Tostrex (testosterone gel) 2 percent for the treatment of male hypogonadism was launched in Sweden by its licensee, ProStrakan Group plc, of Galashiels, UK. Tostrex was approved by the Medical Products Agency in Sweden on Dec. 30. Approvals of Tostrex by the other member states of the European Union are expected in 2006 through the European Mutual Recognition Procedure.

• Cel-Sci Corp., of Vienna, Va., received $625,472 in net proceeds in connection with the settlement of litigation involving a shareholder and three former investors in the company. Cel-Sci is developing new immune system-based treatments for cancer and infectious diseases.

• CeNeS Pharmaceuticals plc, of Cambridge, UK, initiated recruitment in a pivotal Phase III study of its potential new pain drug M6G (morphine-6-glucoronide), which is being studied in Europe in patients with moderate to severe postoperative pain following surgical procedures such as hysterectomy or major gastrointestinal, bowel and urological surgery. Patients will receive total analgesic care from intravenous bolus dosing and patient-controlled analgesia with either M6G or morphine for at least 24 hours following surgery. A total of 428 patients in at least six European countries will participate in the study, which should be completed in the summer of 2006.

• Critical Therapeutics Inc., of Lexington, Mass., received approval from the FDA for its supplemental new drug application to manufacture and market Zyflo for asthma. Zyflo is the only FDA-approved asthma treatment that inhibits the production of 5-lipoxygenase (5-LO), the main enzyme responsible for the production of leukotrienes, a family of inflammatory mediators that can trigger asthma symptoms. Zyflo was first approved to treat asthma in the United States in 1996, and Critical Therapeutics acquired worldwide rights to the drug and other formulations of zileuton in late 2003 and early 2004.

• Generex Biotechnology Corp., of Toronto, increased production of Oral-lyn, its proprietary oral insulin buccal spray product. Generex already began filling several thousand canisters of Oral-lyn in Toronto to validate the equipment for technology transfer to facilities of its partner, PharmaBrand, in Quito, Ecuador. Oral-lyn treats Type I and Type II diabetes.

• Genzyme Corp., of Cambridge, Mass., said results from the Renagel in New Dialysis (RIND) study published in the October issue of Kidney International show that patients with even mild preexisting coronary calcification who used calcium-based phosphate binders experienced more rapid and more severe progression of coronary artery calcification than those using Renagel (sevelamer hydrochloride). The RIND study involved 129 patients new to dialysis, who were evaluated for coronary artery calcification at baseline, and at six, 12 and 18 months using electron beam computed tomography.

• Ingenix, of Basking Ridge, N.J., was selected by the FDA to help improve the effectiveness and speed of safety evaluations for pharmaceutical agents. It will work with the FDA to monitor the safety of new drugs as well as conduct ad hoc safety studies on established pharmaceutical agents.

• Insmed Inc., of Richmond, Va., said the FDA has not yet determined whether the recent approval and granting of orphan exclusivity for Tercica Inc.'s Increlex for severe primary IGF-1 deficiency will block the approval of Insmed's iPlex. The FDA still is considering the issue, it said. In August, the FDA designated orphan drug status for Increlex for severe primary IGF-1 - a status that would guarantee seven years of marketing exclusivity. An approvable letter, which did not ask for additional clinical studies, was issued for iPlex this week. It also has orphan drug status. Insmed's stock (NASDAQ:INSM) fell 18 cents Thursday, or 12.6 percent, to close at $1.25. (See BioWorld Today, Sept. 29, 2005.)

• Lipid Sciences Inc., of Pleasanton, Calif., entered agreements with institutional and accredited investors for a private placement of common stock and warrants. The company will receive about $7.2 million in gross proceeds, and has a potential to raise about $4.5 million more upon the exercise of warrants. Lipid Sciences will use the net proceeds to fund its product development efforts.

• MicroIslet Inc., of San Diego, received a letter from the American Stock Exchange stating that as a result of the company's filing of its Form 10-QSB for the period ended June 30, 2005 with the SEC, the company has regained compliance with the Amex continued listing standards. MicroIslet is engaged in transplantation therapy for people with insulin-dependent diabetes.

• Molecular Insight Pharmaceuticals Inc., of Cambridge, Mass., said Circulation published a Phase IIa study demonstrating that its lead molecular imaging candidate, Zemiva, can detect areas of decreased fatty acid metabolism at rest that parallel defects in cardiac blood flow during stress. The correlation with stress perfusion imaging was noted for up to 30 hours after the stress study was completed and blood flow had normalized. Zemiva is expected to enter Phase III development in the first half of 2006.

• Myriad Genetics Inc., of Salt Lake City, said its researchers, while investigating the genetic differences between DNA samples from about 200 individuals with early onset obesity and a similar number of normal weight subjects, found that those with hyperphagia, an overeating disorder, had a high frequency of mutation in a particular gene. The gene, named COB1, previously was known to be involved in the regulation of insulin signaling, but was not known to be associated with hyperphagia. Myriad said the discovery could lead to diagnosis and treatment of childhood obesity.

• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., reported positive results from a Phase I study of intranasal Parathyroid Hormone (PTH1-34) designed to demonstrate the product's ability to produce a similar pharmacokinetic profile to Forteo (teriparatide, Eli Lilly and Co.), an approved subcutaneously administered product. The study was conducted in 12 healthy subjects between the ages of 20 and 40. All received a single 20 ug subcutaneous injection of Forteo, followed by successive doses of Nastech's PTH1-34 formulation. A six-month non-inferiority trial, with an endpoint of bone mineral density, is expected to begin in 2006.

• Nektar Therapeutics Inc., of San Carlos, Calif., signed an agreement with subsidiaries of Baxter International Inc., of Deerfield, Ill., to develop PEGylated therapeutic forms of blood-clotting proteins for patients with hemophilia, in order to reduce the frequency of injections required. Nektar could receive milestone payments, will get research and development funding and manufacturing revenues, and stands to receive royalties on any commercialized product. Additionally, Nektar has developed an inhaled amphotericin B product for preventing fatal pulmonary fungal infections in immunosuppressed patients to reduce the incidence, morbidity, mortality and high costs of treating the infections. The company has conducted two Phase I trials and has long-term toxicity studies under way to support planned pivotal trials. Nektar also said it is developing inhaled intensive care unit antibiotics for the prevention of ventilator-associated pneumonia (VAP). A proof-of-principle study demonstrated that aerosolized antibiotics reduce the persistence of VAP after its onset by about half, compared to placebo. Nektar expects to start a Phase II study in mid-2006.

• NeoPharm Inc., of Lake Forest, Ill., said its NeoLipid candidate LEP-ETU demonstrated bioequivalence, and it intends to start a 100-patient comparator study in metastatic breast cancer. The trial will take about eight to 10 months to enroll and has a six-month treatment period. NeoPharm expects to submit a new drug application to the FDA in the fourth quarter of 2007.

• Nuvelo Inc., of Sunnyvale, Calif., appointed Ted Love, president and CEO, as chairman of the company's board. George Rathmann, the incumbent chairman, will remain on the board, and serve as chairman emeritus in recognition of his founding role in the company. In addition, Barry Zubrow, the vice chairman of Nuvelo's board, will become the lead independent director.

• PDI Inc., of Saddle River, N.J., said it was selected by Ferring Pharmaceuticals Inc., of Suffern, N.Y., to provide a sales team to support Euflexxa, a non-avian-derived biologic formulation of hyaluronic acid approved in the U.S. for osteoarthritis of the knee. The agreement runs through Sept. 30, 2007, and represents about $17 million to $18 million in potential revenue to PDI over the two years, it said.

• Praecis Pharmaceuticals Inc., of Waltham, Mass., received marketing authorization for Plenaxis (abarelix 100 mg powder for an injectable suspension) from the German regulatory body. The product is indicated in Germany to initiate hormonal castration in patients with advanced or metastatic hormone-dependent prostate cancer, if androgen suppression is appropriate. Praecis also reported that Berlin-based Schering AG terminated the companies' agreement because the drug failed to obtain marketing authorization in Germany by June 20, 2005. Praecis said it intends to explore other potential licensing or sale opportunities to commercialize the product in Europe and other areas.

• Sangamo BioSciences Inc., of Richmond, Calif., was granted research funding over a two-year period from the Cystic Fibrosis Foundation to generate cell lines for cystic fibrosis research using Sangamo's zinc finger DNA-binding protein (ZFP) technology. Company scientists will collaborate with foundation investigators, using the ZFP nuclease technology to introduce the deltaF508 mutation into the CFTR gene in well-characterized cell lines.

• SIGA Technologies Inc., of New York, received notice from Nasdaq that it may be delisted if the common stock does not close above $1 per share, and it has until March 21, 2006, to regain compliance. SIGA said it believes it has regained compliance with the stockholders' equity requirement; its stockholders' equity deficiency resulted from SIGA's decision to accelerate the development and related costs of its lead Smallpox antiviral drug, SIGA-246.

• Spectrum Pharmaceuticals Inc., of Irvine, California, received approval from the Office of Generic Drugs of the FDA for the abbreviated new drug application for fluconazole tablets. Fluconazole is an anti-fungal agent. The branded product, Diflucan, is marketed by Pfizer Inc., of New York.

• Stem Cell Therapeutics Corp., of Calgary, Alberta, signed a contract with Medicon A/S, of Birkerod, Denmark, to perform a Phase I trial. Stem Cell Therapeutics focuses on selectively inducing a patient's own stem cells to proliferate in the brain. Its core technology, which includes the lead product NTx-265, has been shown to increase the number of innate adult stem cells that grow in place when the approach is applied to test animals.

• Strand Life Sciences, of Bangladore, India, entered a research collaboration with Elan Pharmaceuticals, a unit of Dublin, Ireland-based Elan Corp. plc, to support Elan's drug discovery efforts. Elan will access Strand's in silico technology portfolio including predictive modeling for efficacy and ADMET, custom library design, QSAR and pharmacophore modeling, structure-based drug design, data and visual mining and consulting experience.

• Titan Pharmaceuticals Inc., of South San Francisco, said that it has entered an equity line of credit agreement with Cornell Capital Partners LP. Cornell has agreed to provide up to $35 million of funding that can be accessed at the company's discretion over a 24-month period by common stock issuance. Any sale of common shares to Cornell will be based on a five-day weighted average market price at the time of the transaction, and Cornell will receive a 5 percent fee on the value of stock purchases. Proceeds received by the company will be used for product development activities, as well as for general corporate purposes.

• Xanthus Life Sciences Inc., of Cambridge, Mass., received a grant valued at up to $2.3 million from the National Cancer Institute to develop its personalized dosing technology to improve the way cancer drugs are dosed. Xanthus intends to license its ParaMetabolic technology to companies for their use in drug development and lifecycle management. The technology is designed to take into account a patient's genetic makeup, as well as factors such as the effects of drugs taken concurrently, diet and metabolic rate, major organ functions and blood flow.

• XTL Biopharmaceuticals Ltd., of Rehovot, Israel, initiated the Phase Ia trial of XTL-6865 for the treatment of hepatitis C. The trial is being conducted in the U.S. and Israel under an investigational new drug application filed in April. XTL-6865 is a combination of two fully human monoclonal antibodies (Ab68 and Ab65) against the hepatitis C virus E2 envelope protein, and is being developed to prevent HCV re-infection following a liver transplant and for chronic HCV disease.

No Comments