Access Pharmaceuticals Inc., of Dallas, reported positive results from two preclinical studies of its mucositis technology for the prevention and treatment of oral mucositis. The company decided to do additional formulation testing after its Phase II study last year, and now plans to move into a pivotal clinical study. The topical application of the Access mucositis technology was tested for its ability to attenuate the course of radiation-induced oral mucositis in an established hamster model. The study results indicate the ability to prevent the onset of ulcerative mucositis, delay the onset and reduce the severity of mucositis.
AltaRex Corp., of Waltham, Mass., said it issued 185.7 special warrants as part of an offering of up to 1,000 special warrants on a private placement basis. If fully subscribed, the offering could provide up to C$7 million (US$4.4 million) in capital before expenses upon issuance of a receipt for a final prospectus filed with the Ontario Securities Commission. The actual proceeds realized by AltaRex will depend upon the number of special warrants issued in the offering and the price at which the special warrants are automatically converted.
CollaGenex Pharmaceuticals Inc., of Newton, Pa., said the January 2002 issue of the Journal of Clinical Oncology featured a report describing the results of a Phase I trial (sponsored by the National Cancer Institute) designed to evaluate the use of its anti-angiogenesis compound, COL-3 (Metastat), to treat AIDS-related Kaposi’s sarcoma. The study enrolled 18 afflicted patients, 17 of whom had suffered recurrent disease following prior therapy with other drugs. The authors of the paper reported that eight of 18 patients responded to treatment with tumor regression. Metastat is being evaluated in Phase II Kaposi’s sarcoma trials.
Cypress Bioscience Inc., of San Diego, received notification that its securities will continue to be listed on the Nasdaq SmallCap Market pursuant to an exception from the net tangible assets/stockholders’ equity requirement. In January, Cypress received notice from Nasdaq that as of Sept. 30, 2001, it was not in compliance with the minimum tests and was subject to delisting. Cypress plans to regain compliance by selling up to almost 6.9 million shares of common stock and warrants to purchase up to approximately 3.4 million shares of common stock, for a total of up to $17 million, to institutional and accredited investors.
Discovery Laboratories Inc., of Doylestown, Pa., expanded its alliance with Laboratorios Del Dr. Esteve SA, of Barcelona, Spain, to develop, market and sell Surfaxin throughout Europe, Central America and South America. The original collaboration limited the European territory to southern Europe. Discovery is conducting two Phase III trials for respiratory distress syndrome, a Phase III trial for meconium aspiration syndrome and a Phase II trial for acute respiratory distress syndrome. Discovery will be paid $500,000 up front, Esteve will purchase $4 million of Discovery’s common stock at $4.867 per share (a 50 percent premium to the trailing 30-day average as of March 4), and Discovery will receive milestone payments based on specific regulatory approvals. Esteve will fund clinical trials in ALI/ARDS to obtain European approval.
Incellico Inc., of Durham, N.C., has a pilot license agreement with Beyond Genomics Inc., of Waltham, Mass., for its CELL ontological database platform. BG will add CELL to its suite of bioinformatics tools and will use it to help link together experimental and archived databases of genomic, proteomic and metabolic data. Incellico’s CELL product is an ontological database that integrates and reveals contextual knowledge from data sources.
Interneuron Pharmaceuticals Inc., of Lexington, Mass., began a Phase I trial of dersalazine, a potential treatment for inflammatory bowel disease. The Europe-based trial will test the safety and tolerability of multiple ascending doses of dersalazine among healthy volunteers. Results are expected in the second half of the year. Interneuron acquired worldwide marketing rights to dersalazine in September from J. Uriach & Cia. SA, of Barcelona, Spain. Interneuron is responsible for future clinical development, regulatory activities and commercialization.
Ligand Pharmaceuticals Inc., of San Diego, was paid $6 million by Royalty Pharma AG, of Schaffhausen, Switzerland, in exchange for a right to receive 0.25 percent of net sales of three late-stage selective estrogen receptor modulator products for a period of 10 years. Royalty has options, exercisable at its discretion, to purchase at escalating prices additional rights to receive up to 1 percent of the products’ net sales for a period of 10 years, for a total of $56 million. Ligand said the deal enables it, as options are exercised, to increase near-term resources substantially.
Oxford GlycoSciences plc, of Oxford, UK, said CEO Michael Kranda will step down by the end of the year for personal family reasons. The company said it has initiated a search to replace Kranda.
PhotoCure ASA, of Oslo, Sweden, received German marketing authorization for Metvix PDT. Germany is the fourth European country to authorize the product, after Sweden, Norway and Iceland. Marketing authorization also was granted in New Zealand. The company has pending applications in the U.S., Australia and Switzerland. Metvix PDT is a skin cancer treatment that entails the local application of Metvix cream, which is absorbed into the cancer cells, followed by activation of the drug through illumination with a red light source called Curelight.
Prescient NeuroPharma Inc., of Toronto, sold its 60 percent ownership in Precision Biochemicals Inc., a wholly owned subsidiary of IGT Pharma Inc., of Vancouver, British Columbia, to BIRC Corp., also of Vancouver. Financial terms were not disclosed. Prescient said the sale allows it to concentrate resources on research and development in particular on developing PRE703 for anxiety.
Sepracor Inc., of Marlborough, Mass., said the FDA will issue a not-approvable letter for the new drug application for Soltara brand tecastemizole 15-mg and 30-mg capsules. The FDA identified three issues not adequately addressed in certain aspects of the drug’s pharmacokinetics and potential for accumulation in tissue. Two pertained to observations from safety studies in animals that were not observed in humans: phospholipidosis (an adaptive storage response to drug administration) and cardiomyopathy (a pathologic condition of the heart muscle). A third issue concerned the need for additional assurance of the absence of any potential for QTc prolongation (an effect on electrical impulse conduction in the heart). Due to Soltara’s extended elimination phase, the FDA also concluded that additional evaluation of tissue concentrations of the drug after prolonged exposure were needed to quantify the potential for tecastemizole accumulation in target organs. Sepracor’s stock (NASDAQ:SEPR) fell $27.63 Thursday, or 58.5 percent, to close at $19.64.
SuperGen Inc., of Dublin, Calif., said it product rubitecan will now be called Orathecin. The product has completed enrollment in a Phase III trial in pancreatic cancer. SuperGen and Abbott Laboratories Inc., of Abbott Park, Ill., earlier this week ended their partnership on the drug. (See BioWorld Today, March 6, 2002.)