• Access Pharmaceuticals Inc., of Dallas, received notice from the American Stock Exchange on April 28 that the company is not in compliance with Amex's continued listing standards due to losses from continuing operations and lower shareholders equity amounts. Amex requested that Access submit a plan before May 31 outlining the actions it has taken, or will take, that would bring it into compliance within a maximum of eight months.

• Acologix Inc., of Hayward, Calif., initiated the first Phase II study using AC-100 (Dentonin) in dentistry. The company said the product, a synthetic peptide derived from an endogenous human protein produced by bone and dental cells, has demonstrated selective dental tissue and bone formation activity in preclinical models, and was well tolerated in a Phase I study. It is being developed for dental, periodontal and orthopedic indications.

• Alpharma Inc., of Fort Lee, N.J., said the FDA granted Kadian 200-mg capsule approvable status. Kadian is the company's sustained-release morphine sulfate product for pain that is marketed in 20-mg, 30-mg, 50-mg, 60-mg and 100-mg dosages.

• Amarillo Biosciences Inc., of Amarillo, Texas, received a $104,372 Small Business Innovation Research grant from the National Institutes of Health. The grant will be used to develop a vaccine to combat Helicobacter pylori, a major cause of gastritis and gastroduodenal ulcer disease in humans. Amarillo will collaborate with Steven Krakowka of the Ohio State University, funding research and development of a vaccine and an oral interferon cocktail formulation for use as an adjunct to antimicrobial therapies.

• Berlex Inc., of Montville, N.J., a U.S. affiliate of Schering AG, completed patient enrollment for a Phase II trial of Leukine in steroid-dependent patients as a treatment for Crohn's disease. The trial, called Novel 2, is being conducted in the U.S. and Canada. Results are expected in 2006.

• BioMarin Pharmaceutical Inc., of Novato, Calif., has licensed from Tokyo-based Daiichi Suntory Pharma Co. Ltd. the exclusive worldwide rights (excluding Japan) for the use of tetrahydrobiopterin (6R-BH4) to treat the endothelial dysfunction that causes vascular complications in diabetes, cardiovascular and other diseases. The compound is the active ingredient in Phenoptin (sapropterin hydrochloride), BioMarin's investigational Phase III product for the treatment of phenylketonuria (PKU). Those rights expand BioMarin's market opportunity beyond PKU. Under the licensing agreement, BioMarin will pay Daiichi an up-front payment, an undisclosed royalty payment on sales and development milestones for up to two indications.

• Callisto Pharmaceuticals Inc., of New York, said results of animal studies on SP304 in inflammatory bowel disease and other gastrointestinal disorders showed the drug was effective in an inducible animal model of colitis. Additional preclinical experiments are under way to further define the drug's therapeutic potential. SP304 is an analogue of native human peptide uroguanylin, a guanylate cyclase receptor agonist normally produced in the intestinal tract, but it is underexpressed in pathological conditions.

• Cellegy Pharmaceuticals Inc., of Brisbane, Calif., said it received a letter from the FDA indicating that the agency is reviewing the company's amended new drug application submitted recently for Cellegesic (0.4 percent nitroglycerin ointment) in the treatment of pain associated with chronic anal fissure. The company expects the FDA to respond by the target date of June 15. Cellegy's resubmission was accepted as a response to the FDA's not-approvable letter issued in December for Cellegesic, and the company said it includes a minor re-analysis of data previously submitted. (See BioWorld Today, Dec. 28, 2004.)

• Corcept Therapeutics Inc., of Menlo Park, Calif., initiated its third Phase III trial designed to evaluate Corlux (mifepristone) for the treatment of the psychotic features of psychotic major depression. Corlux has been granted fast-track designation for that indication. The company anticipates having initial results from the study available by the end of 2006. Corcept began the first pivotal study shortly after reaching an agreement with the FDA in August on the special protocol assessment, and started a second trial late last year. Results from those two ongoing Phase III trials are expected to be reported during the first half of 2006. (See BioWorld Today, Aug.31, 2004.)

• CytRx Corp., of Los Angeles, said its lead small-molecule drug candidate, arimoclomol, for the treatment of amyotrophic lateral sclerosis, received orphan drug designation by the FDA, which would allow the company grant funding for clinical trials and seven years of marketing exclusivity if the product is approved. The company expects to file an investigational new drug application for arimoclomol this month and enter a Phase II trial later this quarter.

• Dharmacon Inc., of Lafayette, Colo., entered an agreement to deliver a genome-wide short-interfering RNA library covering about 22,000 human genes to Millennium Pharmaceuticals Inc., of Cambridge, Mass. The library, which is the first siRNA collection targeting genes across the human genome, was developed using Dharmacon's SMARTselection and SMARTpool technologies.

• Digene Corp., of Gaithersburg, Md., and Luminex Corp., of Austin, Texas, agreed to licensing terms providing Digene access to Luminex's xMAP bead-based multiplexing technology for use in women's health diagnostics. Digene acquired nonexclusive worldwide rights to commercialize certain in vitro clinical diagnostic tests using Luminex's xMAP technology.

• Dov Pharmaceutical Inc., of Hackensack, N.J., said the Proceedings of the National Academy of Sciences published an article this week detailing preclinical and clinical findings with ocinaplon, the company's Phase III candidate to treat anxiety disorders. Ocinaplon was found to produce selective actions on certain GABAA receptor subtypes. The findings might provide an explanation for ocinaplon's ability to produce an anti-anxiety action in both animal models and humans at doses that do not produce the side effects associated with benzodiazepine administration.

• Entelos Inc., of Foster City, Calif., and the American Diabetes Association, of Alexandria, Va., completed an in silico model of non-obese Type I diabetes, marking the end of the first year of a two-year collaboration. The Type I Diabetes PhysioLab platform is designed to help researchers study the NOD mouse model to bridge the gap between animal research and patients. During the second year of the collaboration, the Entelos research team will conduct in silico research in the NOD mouse platforms, add biological detail and create a population of virtual NOD mice to represent and explore the heterogeneity and uncertainty in the disease's processes.

• Eyetech Pharmaceuticals Inc., of New York, said that imaging data from a Phase II study of Macugen (pegaptanib sodium injection) in diabetic macular edema (DME) showed a reversal of capillary microaneurysms, retinal ischemia and neovascularization. Macugen is indicated in the U.S. for the treatment of neovascular age-related macular degeneration and is not approved for the treatment of DME.

• Generex Biotechnology Corp., of Toronto, plans to launch sales of its oral insulin spray formulation, Oral-lyn, this year. Authorities in Ecuador have approved Oral-lyn to treat patients with Type I and Type II diabetes. Generex expects approval in Venezuela, Colombia, Peru and Bolivia. The product is partnered in that region with PharmaBrand SA, of Quito, Ecaudor.

• Genzyme Corp., of Cambridge, Mass., said the Cochrane Collaboration published a lengthy review examining the clinical benefits of Synvisc and the class of viscosupplements to which it belongs. As the leading viscosupplementation product to treat pain due to osteoarthritis of the knee, Synvisc is delivered locally and avoids many side effects of traditional non-steroidal anti-inflammatory drugs and COX-2 agents. The review showed that considerable, positive differences were found in favor of Synvisc vs. placebo, including improvements in pain, stiffness and physical functioning.

• Ligand Pharmaceuticals Inc., of San Diego, said the Nasdaq Listing Qualifications Panel has agreed to continue listing the company's securities, provided that Ligand files its report for the 2004 fiscal year, as well as its report for the first quarter of 2005, on or before July 29. The company announced in March that it had received notice from Nasdaq that it was not in compliance with listing requirements.

• Martek Biosciences Corp., of Columbia, Md., is the subject of a lawsuit filed by the firm of Schatz & Nobel PC, of Hartford, Conn., seeking class-action status on behalf of all purchasers of Martek's securities between Dec. 9 and April 27. The complaint alleges that Martek violated federal securities laws by making false or misleading public statements, and that the company flooded its major customers with inventory in excess of their allotted levels so it could meet its financial numbers and complete an $81.4 million stock offering. Martek updated its earnings April 27, revealing an anticipated decrease in third-quarter sales, causing the company's shares to plunge nearly 46 percent, closing at $32.49.

• Medicure Inc., of Winnipeg, Manitoba, said that results from a preclinical in vivo study showed potential for MC-1 in the treatment of hypertriglyceridemia. The effects of MC-1 were evaluated in an industry-standard cholesterol model. Treatment with MC-1 for seven weeks was associated with a 72 percent reduction in triglyceride levels vs. control (p=0.03). Additionally, MC-1 also demonstrated an improvement vs. an approved triglyceride reduction agent in the model, the company said.

• Oxford BioMedica plc, of Oxford, UK, presented preclinical data from the RetinoStat program at the annual meeting of the Association for Research in Vision and Ophthalmology in Fort Lauderdale, Fla. The data show that two versions of the product are efficacious in an industry standard model of age-related macular degeneration (AMD). RetinoStat uses a lentivector system to deliver to the retina genes that block the formation of new blood vessels that cause AMD.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., submitted an investigational new drug application to initiate a Phase I trial using Tarvacin to treat patients with chronic hepatitis C virus infections. The objectives of the trial are to evaluate safety, pharmacokinetics and viral load in patients who have failed standard treatment. It is the second IND filing for Tarvacin, developed under Peregrine's anti-phospholipid therapy technology platform, which previously was cleared for testing in patients with solid cancer.

• Regal One Corp., of Los Angeles, recently acquired a 10 percent interest in Nevada-based American Stem Cell Corp. (ASC). Regal One has the option to acquire additional equity, and it plans to issue a portion of its ASC shares as dividends to its shareholders. ASC, which will relocate to southern California, is a development-stage company that is acquiring Los Angeles-based Lifeline Cell Technology LLC.

• Rigel Pharmaceuticals Inc., of South San Francisco, received two milestone payments from Tokyo-based Daiichi Pharmaceuticals Ltd. as part of their collaboration to identify an oncology drug. The two compounds related to the payments are selective inhibitors of a specific ligase target, which Daiichi will work to advance into preclinical development. The research collaboration began in August 2002 and aims to identify specific small-molecule drug candidates against a ligase target that controls cancer cell proliferation through protein degradation.

• Sangamo BioSciences Inc., of Richmond, Calif., initiated a Phase I trial of SB-509, a therapeutic designed to protect and stimulate the regeneration of peripheral nerve function in diabetics suffering from peripheral neuropathy. The study is designed to evaluate the safety of SB-509 in diabetics with mild to moderate diabetic peripheral sensory motor neuropathy in the legs. SB-509 is an injectable formulation of plasmid DNA that encodes a zinc finger DNA-binding protein transcription factor, designed to up-regulate the vascular endothelial growth factor A gene.

• Seattle Genetics Inc., of Bothell, Wash., has entered an agreement with Albany Molecular Research Inc., of Albany, N.Y., for cGMP manufacturing of its drug-linker system used for its SGN-35 product candidate. SGN-35 is an antibody-drug conjugate (ADC) composed of an anti-CD30 monoclonal antibody stably linked to an auristatin derivative using Seattle Genetics' second-generation ADC technology. Seattle Genetics also has established a preferred provider relationship with Albany Molecular that enables licensees of Seattle Genetics' ADC technology to work with Albany Molecular to obtain cGMP supplies of drug-linkers.

• Shire Pharmaceuticals Group plc, of Basingstoke, UK, said in vitro data presented at the National Kidney Foundation's 2005 clinical meeting in Washington, showed that Fosrenol binds phosphate across a broad pH range with higher affinity than sevelamer hydrochloride. Once bound, the Fosrenol/phosphate complex cannot pass through the intestinal lining into the blood and is eliminated from the body, which decreases the overall phosphate absorption from food. Fosrenol received FDA approval last October and is indicated to reduce serum phosphate.

• Vasogen Inc., of Toronto, reached full enrollment in the 2,000 patient pivotal Phase III ACCLAIM trial in advanced chronic heart failure. That trial is designed to assess the impact of Vasogen's Celacade technology on the risk of death and cardiovascular hospitalization in patients with advanced chronic heart failure. Vasogen said the trial remains on schedule and is expected to reach its primary endpoint during the second half of the year.

• Vivus Inc., of Mountain View, Calif., reported results from a clinical trial designed to evaluate the feasibility of twice-a-day dosing with avanafil, its oral phosphodiesterase Type 5 inhibitor being developed for the treatment of erectile dysfunction. Results revealed no significant plasma accumulation of avanafil after the twice-a-day treatment when compared to a single dose.