¿ Adolor Corp., of Exton, Pa., released positive results from the final Phase II trial of ADL 8-2698, a compound for the management of opioid-induced bowel dysfunction. ADL-8-2698 is a gastrointestinal tract-restricted opioid narcotic antagonist designed to treat or prevent the gastrointestinal side effects of opioid analgesics such as morphine and codeine. The trial was a double-blind, placebo-controlled study in opioid-induced constipation involving 20 patients randomly receiving a placebo, 0.5 mg or 1 mg of ADL 8-2629 for 21 days. Adolor reported that both groups taking the drug had improved frequency and quality of bowel movement in a dose-response fashion vs. the placebo group and that the drug effect was sustained throughout the duration of the trial. No serious side effects were recorded, the company said.
¿ Amgen Inc., of Thousand Oaks, Calif., said that it did not receive FDA approval for its Aranesp (darbepoetin alfa) for the treatment of anemia associated with chronic kidney disease in the first half of the year, as it expected. Amgen said, however, that discussions with the FDA were continuing. ¿We continue to be encouraged with the progress at the FDA on its review of Aranesp and our label discussions. The FDA has not asked for additional data,¿ said Kevin Sharer, Amgen¿s CEO.
¿ Bioniche Life Sciences Inc., of Belleville, Ontario, said it completed the first tranche in a private placement of special warrants that will result in approximately C$6 million (US$3.97 million) in gross proceeds for the company. Once completed, the company said it expects C$10 million in total gross proceeds. The warrants are being offered at C$3.05 per warrant, with each warrant convertible into one share of common stock within 120 days following the closing of the private placement. The company said it would use the proceeds to continue the development of its lead proprietary technology, MCC, for the treatment of bladder and prostate cancer, and for other purposes.
¿ Collateral Therapeutic Inc., of San Diego, said researchers at the University of Texas Southwestern Medical Center at Dallas identified a novel cardiac-specific gene expression activator for Collateral¿s heat muscle regeneration program. In September 2000, Collateral entered into an agreement with UT Southwestern to exclusively license certain human genes discovered by the university. In preclinical studies published in the June 29, 2001, issue of Cell, university researchers showed that a novel and highly potent transcription factor (a gene regulator) called Myocardin is expressed specifically in cardiac and smooth muscle cells and is capable of up-regulating a number of cardiac-specific genes in non-muscle cells.
¿ Durect Corp., of Cupertino, Calif., released preliminary results from the Phase II trial of its lead product, a three-month continuous infusion subcutaneous implant for the treatment of chronic pain. The product, previously called DUROS sufentanil, was renamed Chronogesic. Results showed patients had clinically significant improvement in pain control and had reductions in some opioid side effects compared to previous opioid therapies, the company said. A full analysis of study results is under way. Patients were enrolled at nine clinical sites and ranged in age from 26 to 68. The study included patients whose chronic pain was stable and opioid responsive, and resulted from a variety of malignant and non-malignant causes.
¿ Generex Biotechnology Corp., of Toronto, reported promising data from studies showing that Oralin, its oral insulin formulation, may be used safely and effectively in place of injected insulin to treat Type I and Type II diabetes. Oralin is delivered as a fine spray to the buccal cavity using Generex¿s Rapidmist device, where the formulation is absorbed through the buccal mucosal lining. Generex entered into an agreement with Eli Lilly and Co., of Indianapolis, in September 2000 to develop oral insulin technology.
¿ Hollis-Eden Pharmaceuticals Inc., of San Diego, received FDA clearance to begin clinical trials of HE2200, an immune-regulating hormone (IRH) drug candidate. The company said HE2200 has shown to provide significant benefit in a number of animal models of immune dysregulation. Preclinical studies with HE2200 and initial clinical studies with the company¿s lead IRH, HE2000, indicate this class of compounds may improve defects in cell-mediated immunity. The randomized, double-blinded, placebo-controlled Phase I trial is expected to begin sometime this month and assess safety and tolerance of HE2200 at two dosage levels in healthy adult elderly volunteers.
¿ Illumina Inc., San Diego, Calif., signed a commercial agreement with GlaxoSmithKline plc, of London, to provide single nucleotide polymorphism genotyping services on a sample collection provided by GSK. Illumina said it will use its BeadArray technology to determine the frequency of specified SNPs in the sample set. Additional details were not disclosed. Illumina develops tools for large-scale analysis of genetic variation and function.
¿ NeoTherapeutics Inc., of Irvine, Calif., said it has expanded its Phase II Neotrofin spinal cord injury trial to include Gaylord Hospital in Wallingford, Conn. Gaylord is affiliated with Yale University and the University of Connecticut, and is the second site participating in the trial. Patients will receive Neotrofin for 12 weeks and will be evaluated at regular intervals.
¿ Orchid BioSciences Inc., of Princeton, N.J., said it successfully completed the first milestone in its multiyear genotyping and pharmacogenetics collaboration with AstraZeneca, of London, resulting in a significant payment to Orchid. Financial details were not disclosed. Using SNPcode technology, combining its SNP-IT biochemistries and the GenFlex and GeneChip system of Affymetrix Inc., of Santa Clara, Calif., Orchid developed assays and conducted genotyping for the first cohort of samples provided by AstraZeneca. Based on these results, the companies will proceed to the next phase of the collaboration. Orchid¿s stock (NASDAQ:ORCH) gained 30.3 percent Friday, or $1.78, to close at $7.65.
¿ Ortec International Inc., of New York, signed a letter of intent with the Paul Capital Royalty Acquisition Fund, of New York, for the fund to provide up to $25 million of non-equity capital to Ortec based on achieving specified milestones. Ortec would receive $5 million upon execution of a definitive agreement. In consideration of its investment, the Paul Royalty Fund would receive a royalty percentage of future annual North American end-user sales of Ortec¿s Composite Cultured Skin product through 2011. Pending completion of due diligence, the transaction is expected to be completed by August.