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Clinic Roundup
(BioWorld Today Via Acquire Media NewsEdge) , of Vienna, Austria, has completed recruiting all 24 Alzheimer's patients planned for its Phase I trial of AFF001, which aims to investigate the safety and tolerability of the compound. All patients have received at least one of the four vaccinations administered monthly, and the company expects to complete the trial by October.
? Amgen Inc., of Thousand Oaks, Calif., and Wyeth Pharmaceuticals, a division of Wyeth, of Madison, N.J., said half of patients treated with the combination of Enbrel and methotrexate achieved disease activity score (DAS) clinical remission and nearly all had no progression of joint damage. The findings were published online in The Lancet. According to study data at one year, 50 percent of patients (n = 265) with active early moderate-to-severe rheumatoid arthritis who received a combination of Enbrel and methotrexate therapy achieved DAS clinical remission (DAS28 < 2.6) vs. 28 percent (n = 263) of those treated with methotrexate alone. Additionally, at one year, 80 percent of patients (n = 246) receiving ENBREL and methotrexate had no evidence of progression of joint damage as seen on X-ray, compared to 59 percent (n = 230) of those treated with methotrexate alone. Data also showed the combination therapy helped patients remain more functionally active and showed that patients who were treated with combination therapy had a nearly threefold reduction in work stoppage compared with those who received methotrexate alone. The trial, called COMET, is a 24-month, double-blind, randomized, parallel group, multicenter, outpatient study. The reported data represent the first year.
? Chelsea Therapeutics International Ltd., of Charlotte, N.C., said that 147 patients of the planned 200 patients have been enrolled to date in its Phase II trial of its lead drug candidate CH-1504 in rheumatoid arthritis initiated in January. The trial is a 12-week, 4-arm, parallel group study comparing 0.25 mg, 0.5 mg and 1 mg once-daily oral doses of CH-1504, an orally available and metabolically inert antifolate, to a 20-mg once-weekly oral dose of MTX, the current leading antifolate treatment. The primary efficacy endpoint of the study is to determine the percent of patients with ACR 20 response, which is a standard efficacy measure that requires at least a 20 percent improvement in a number of different measures of disease activity, at the end of 12 weeks.
? Compugen Ltd., of Tel Aviv, Israel, has begun the planning for a proof-of-concept human trial for CGEN-50001, a known central nervous system drug with a well-established safety profile, for breast cancer therapy in 2009. Compugen's new indications discovery platform predicted in silico that CGEN-50001 likely would strengthen the effect of anti-breast cancer drugs, which target the estrogen receptor, such as Tamoxifen. In vivo validation study in mice model of breast cancer indicated CGEN-50001, in combination with Tamoxifen, reduced tumor better compared to Tamoxifen alone. CGEN-50001 also appeared to induce cancer cell death and inhibit cell proliferation.
? Dendreon Corp., of Seattle, announced the initiation of a first of two Phase II trials of Provenge (sipuleucel-T), an investigational active cellular immunotherapy for the treatment of prostate cancer, in men with localized prostate cancer who are scheduled to undergo a radical prostatectomy. Each patient will receive three 2-week-apart infusions of Provenge prior to patient's radical prostatectomy, and will be randomized afterward to receive either a booster of Provenge or no booster. Multiple safety and efficacy endpoints will be evaluated including the immune response in the prostatectomy specimens and in the peripheral blood.
? Hollis-Eden Pharmaceuticals Inc., of San Diego, said it started a Phase II trial with its oral drug candidate Triolex (HE3286), a first-in-class insulin sensitizer, in Type II diabetes, and it also is expanding the number of clinical sites to accelerate enrollment. The double-blind placebo controlled 12-week dosing trial will enroll approximately 90 patients who are stable on metformin treatment only, the current first-line therapy for Type II diabetes, with a hemoglobin A1c (HbA1c) level in excess of 7.5 percent. The primary endpoints for the trial will be safety and a reduction in HbA1c. The company expects to release a preliminary interim data in the forth quarter and to complete enrollment by the end of the year.
? MAP Pharmaceuticals Inc., of Mountain View, Calif., said positive results from a Phase II study evaluating the safety, tolerability and pharmacokinetics of MAP0004 in adult asthmatics were published in the July 2008 issue of Current Medical Research and Opinion. MAP Pharmaceuticals is developing MAP0004, an orally inhaled and self-administered therapy, as a potential treatment for migraine. The data demonstrated treatment with MAP0004 resulted in rapid and efficient systemic absorption of the therapeutic compound, dihydroergotamine in asthmatic subjects, and absorption was comparable to that observed in a previous study of healthy volunteers.
? Proteome Systems Ltd., of Sydney, Australia, said it ceased the development of a diagnostic test for prostate cancer based on the results of a proof-of-concept study that demonstrated the project did not satisfy internal assessment hurdles. The study evaluated the merits of human carcinoma antigen as a semen-based diagnostic marker for prostate cancer.
? Symphogen A/S, of Lyngby, Denmark, and Biovitrum AB, of Stockholm, Sweden, announced the first patient recruitment into a Phase II trial, initiated in June, to evaluate the safety and efficacy, and explore the dose range of Sym001, a recombinant, polyclonal anti-Rhesus D antibody, in idiopathic thrombocytopenic purpura (ITP) patients. ITP is an autoimmune bleeding disorder characterized by abnormally low platelet levels, making it difficult for the blood to clot normally. The study will observe the increase in platelet levels and explore the mechanism of action of Sym001 by assessing its binding to red blood cells.
? Teva Pharmaceutical Industries Ltd., of Jerusalem, and Active Biotech AB, of Lund, Sweden, said patients are being enrolled for the BRAVO Phase III pivotal trial. BRAVO is a global, 24-month, double-blind study designed to evaluate the efficacy, safety and tolerability of the oral compound laquinimod vs. placebo, and to provide risk-benefit data for laquinimod vs. a currently available injectable treatment, Avonex.
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