• Cytos Biotechnology AG, of Zurich, Switzerland, reported its Phase I results for the Immunodrug candidate CYT006-AngQb, a therapeutic vaccine for the treatment of hypertension. Those data were obtained from a pilot study with 15 volunteers. All 12 participants receiving the vaccine mounted an angiotensin II-specific antibody response; the four participants receiving placebo showed no detectable angiotensin.
• Depomed Inc., of Menlo Park, Calif., initiated a Phase II trial of its gabapentin extended-release tablets to treat patients with post-herpetic neuralgia, a long-lasting pain condition associated with nerve damage from herpes zoster or shingles. The trial is expected to involve about 25 U.S. sites and 150 post-herpetic neuralgia patients.
• Diversa Corp., of San Diego, achieved a milestone under its research and development agreement with Syngenta AG, of Basel, Switzerland, triggering a $500,000 payment. Diversa delivered to Syngenta multiple qualified enzyme candidates for use as animal feed additives. The companies formed their initial agreement in December 2002.
• EntreMed Inc., of Rockville, Md., presented research results at the 7th International Symposium on Anti-Angiogenic Agents, which concluded Sunday in San Diego. Findings from in vitro and in vivo studies of Panzem NCD demonstrated that antitumor activity is maximized by maintaining threshold concentrations of 2ME2 for defined periods. Results from preclinical studies of the lead second-generation oral 2ME2 analogue, ENMD-1198, also were presented. ENMD-1198 demonstrated improved antitumor and anti-angiogenic activities in in vitro and in vivo preclinical models. A third presentation highlighted the company's cancer vaccine candidate, ENMD-00996. The vaccine, which produces cellular and humoral immune responses to FGF-2, demonstrated both anti-angiogenic and tumor inhibition in preclinical models.
• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said it licensed a cancer antisense drug to Sarissa Inc., of London, Ontario. The drug is an antisense inhibitor of thymidylate synthase, a drug target that protects cancer cells from the effects of several chemotherapy treatments. Sarissa will pay Isis a $1 million up-front fee in exchange for the exclusive, worldwide license, and it will pay clinical and regulatory milestone payments, as well as royalties on product sales.
• Jerini AG, of Berlin, completed a €15.5 million (US$20.1 million) round of private financing. The follow-on financing to the oversubscribed €31 million round closed in June and will support the development of the company's lead product, Icatibant, for hereditary angioedema, as well as the advancement of Jerini's other drug discovery programs. Jerini is focused on the development and commercialization of peptide-derived and small-molecule therapeutics.
• Kosan Biosciences Inc., of Hayward, Calif., reported the start of a multicenter Phase II trial to evaluate the safety and efficacy of KOS-862 as monotherapy for prostate cancer. KOS-862 is a polyketide that inhibits cancer cells by the same mechanism as paclitaxel, and preclinical models have shown the compound to be effective against paclitaxel-resistant tumors. Under a global development and commercialization agreement, F. Hoffmann-La Roche Ltd., of Basel, Switzerland, has the worldwide exclusive right to market and sell KOS-862 and epothilone and analogues owned by or licensed to Kosan for the treatment of cancer. Kosan will co-develop and has the right to co-promote Kosan/Roche epothilone products in the U.S. for the treatment of cancer.
• Lumera Corp., of Bothell, Wash., and the Institute for Systems Biology in Seattle agreed to collaborate on the development of a high-throughput, label-free detection platform designed to revolutionize proteomics research. The technology platform consists of Lumera's ProteomicProcessor and NanoCapture Array technology.
• Medicis Pharmaceutical Corp., of Scottsdale, Ariz., said the FDA approved its new drug application for Vanos, a Class I corticosteroid for the treatment of plaque-type psoriasis. Vanos is a cream for once- or twice-daily application. Medicis expects to launch the product in the quarter beginning in April.
• NeoRx Corp., of Seattle, said it will start a Phase II trial in the middle of the year for Skeletal Targeted Radiotherapy (STR) based on updated Phase I data presented from an investigator-sponsored trial in patients with advanced breast cancer. The trial involved six patients with Stage IV breast cancer that metastasized to the bone who received STR as a single agent followed by autologous blood stem cell rescue. Two of the six patients remain alive, without progression of disease up to six years post-transplant. For the other four patients, the overall median time to disease progression was 10 months.
• Sosei Co. Ltd., of Tokyo, said SOT-107 (TransMID) was granted orphan drug status for the treatment of glioma in Japan. Sosei licensed rights to the product in Japan and Taiwan from Xenova Group plc, of London, in November 2002. The FDA and the European Medicines Agency's Committee for Orphan Medicinal Products granted orphan designation for TransMID in 2001 and 2002, respectively. TransMID entered Phase III trials last year.
• TheraQuest Biosciences LLC, of Blue Bell, Pa., said it developed a safer, long-acting, once-a-day formulation of the pain drug tramadol, which it calls TQ-1017. It is designed to deter recreational use, prescription abuse or accidental misuse of tramadol, and it should enter Phase III trials this year. Tramadol works by serotonin and norepinephrine reuptake inhibition, and through a narcotic effect similar to oxycodone.
• Xcyte Therapies Inc., of Seattle, said results from two trials of Xcellerated T cells showed the therapy was well tolerated and resulted in significant increases in circulating lymphocytes, particularly T cells. A Phase I/II study in patients with multiple myeloma showed recovery of lymphocytes and T cells was much more rapid than seen in patients treated with the same therapeutic regimen without receiving Xcellerated T Cells, and 89 percent of patients had a significant tumor response. A Phase II study in patients with relapsed or refractory indolent non-Hodgkin's lymphoma showed the infusions were well tolerated, had no serious adverse events and demonstrated sustained increases in T-cell counts.