Algeta ASA, of Oslo, Norway, started patient recruitment in a pivotal Phase III study of targeted therapeutic Alpharadin in advanced, hormone-refractory prostate cancer (HRPC) that has metastasized to the skeleton. The ALSYMPCA (Alpharadin in SYMptomatic Prostate CAncer) study is expected to enroll about 750 patients to be randomized 2-to-1 to receive Alpharadin plus best standard of care or placebo plus best standard of care. The primary efficacy endpoint is overall survival, while secondary endpoints will include time to occurrence of specified disease-related events and time to progression of certain key biomarkers indicative of disease status, including blood levels of serum prostate-specific antigen and total alkaline phosphatase. The Phase III trial was designed based on earlier results from Phase II studies, which showed that the drug, a targeted treatment formulated from a salt of radium-223, provided significant survival benefit compared to placebo in HRPC patients with metastases.
Biopure Corp., of Cambridge, Mass., said the U.S. Naval Medical Research Center submitted a new protocol for FDA review of a Phase II trial of Hemopure, or HBOC-201, for resuscitation of operational casualties with severe traumatic hemorrhagic shock without availability of blood transfusions. The OpRESUS (Operational Restore Effective Survival in Shock) study is designed to enroll up to 340 evaluable subjects, with a primary aim of comparing the 28-day relative rate of death in patients receiving Hemopure vs. patients receiving the standard fluid for resuscitation (Hextend). Pending successful results, an application will be submitted to the FDA for a Phase III trial.
BioTie Therapies Corp., of Turku, Finland, said its VAP-1 antibody program will proceed to clinical studies, expected to start at the end of this year in rheumatoid arthritis and psoriasis patients, after top-line data from the first-in-man study showed that its fully human VAP-1 monoclonal antibody BTT-1023 generally was well tolerated, with no serious adverse events reported. That study was designed to assess tolerability and pharmacokinetic characteristics of single intravenous doses of BTT-1023 in healthy volunteer subjects.
Epigenomics AG, of Frankfurt, Germany, completed a larger clinical study in its lung cancer program. The study on 256 patient samples confirmed that a two-biomarker panel correctly identified two-thirds of all lung cancers in blood plasma at a false-positive rate of 12 percent. About two-thirds of the blood samples used in the study were obtained from patients with early Stage I and II cancer. Sensitivity in Stage II lung cancer patients reached 73 percent. Those latest results independently confirmed previous data from a smaller proof-of-concept study performed by Epigenomics in 2007 that was weighted toward later-stage disease.
Inotek Pharmaceuticals Corp., of Beverly, Mass., started enrollment in a Phase I trial of its selective adenosine 1 agonist, INO-8875, in glaucoma. That study will evaluate the safety, tolerability and the potential of INO-8875 to lower intraocular pressure in glaucoma patients.
Panacos Pharmaceuticals Inc., of Watertown, Mass., completed a Phase IIb prospective study of bevirimat, its lead HIV maturation inhibitor, in treatment-experienced and treatment-naïve patients and confirmed the recently discovered factors that predict response to bevirimat. With 14 days of bevirimat treatment, patients with the predictors of response - those with no polymorphism at Gag amino acid positions 369, 370 or 371 on the 500-amino acid HIV-1 Gag protein - had a statistically significantly higher mean viral load reduction than patients with polymorphisms (variants) at those positions. All patients achieved the target blood level required for optimal response with the 300-mg bevirimat dose administered, and the adverse event profile in the study was indistinguishable from placebo.
Resverlogix Corp., of Calgary, Alberta, completed an exploratory efficacy analysis of data from Phase I, seven-day RVX-208 treatment subjects. Analysis from two independent, external laboratories of blinded serum samples showed consistent improvements of key biomarkers for the reverse cholesterol transport (RCT) pathway. RCT is a pathway by which accumulated cholesterol is transported from the arterial wall to the liver for excretion, preventing atherosclerosis.
Shire Ltd., of Basingstoke, UK, published the data from a Phase III, open-label, 12-month extension study of ulcerative colitis drug Lialda (mesalamine) dosed once (2.4 g/day) or twice daily (1.2 g twice daily) in the July 2008 issue of Gut. Results showed Lialda demonstrated a good safety profile. There was no significant difference between the once-daily and twice-daily groups with respect to strictly defined clinical and endoscopic remission at month 12. Also, 88.9 percent and 93.2 percent of patients in each group, respectively, maintained clinical remission and were considered relapse-free.
Tracon Pharmaceuticals Inc., of San Diego, said it initiated first patient treatment in a Phase I trial of oral TRC102, a cancer drug intended to reverse resistance to Alimta (Eli Lilly & Co.) chemotherapy by targeting a specific DNA repair pathway. The trial will assess the safety, tolerability and pharmacokinetics, as well as preliminary antitumor activity, of TRC102 in patients with advanced cancer who also receive Alimta. Intravenous TRC102 also is being dosed to cancer patients in a Phase I trial in combination with Temodar (Schering-Plough).