• Algeta ASA, of Oslo, Norway, said it finalized the study design for its pivotal Phase III trial of Alpharadin in hormone-refractory prostate cancer and anticipates enrolling the first patient before mid-2008. A total of 450 patients will be involved in the study, which will evaluate overall survival as the primary endpoint.

• Altor BioScience Corp., of Miramar, Fla., finished treating the first cohort of metastatic cancer patients in a Phase I/IIa trial of ALT-801, a tumor-targeted immunotherapeutic designed to improve on the efficacy and safety of FDA-approved anticancer cytokine interleukin-2. The trial's primary objectives are to evaluate safety, determine the maximum-tolerated dose and characterize the pharmacokinetic profile, while secondary objectives are to evaluate immunogenicity and assess antitumor response. Altor also reported that the expansion phase of that study will be supported in part through funding awarded by the FDA's Orphan Products Development Grant Program.

• Athersys Inc., of Cleveland, and Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, received FDA clearance to start a Phase I trial of MultiStem, an allogeneic cell product, in acute myocardial infarction. MultiStem is designed to be injected directly into and around the zone of myocardial injury from an intracoronary approach. The companies agreed in May 2006 to co-develop and commercialize Athersys' non-embryonic stem cell platform technology for use in AMI and peripheral vascular disease. Upon completion of the Phase I trial, Angiotech will assume lead responsibility for further clinical development. Angiotech also owns marketing and commercial rights.

• Collegium Pharmaceutical Inc., of Cumberland, R.I., reported positive study results from its proof-of-concept trial for an abuse-deterrent, sustained-release, oral oxycodone formulation (COL-003), in development for pain. The company is in the process of submitting the final study report to the FDA and plans to request a meeting with the agency to discuss protocol for an upcoming pivotal program. COL-003 has been granted fast-track status by the FDA.

• Conatus Pharmaceuticals Inc., of San Diego, started a trial of CTS-1027 in liver disease associated with hepatitis C virus infection in 100 patients who have failed approved standard-of-care treatments. CTS-1027 is designed to inhibit the activity of matrix metalloproteinases, which play a role in regulating inflammation and in maintaining the integrity of the extracellular matrix.

• CytRx Corp., of Los Angeles, started screening volunteers for its Phase IIb trial of arimoclomol in amyotrophic lateral sclerosis. The company expects it to take about nine months to finish enrolling about 390 patients in the trial, which will evaluate 400 mg arimoclomol administered orally three times daily for a nine-month period. CytRx plans to continue double-blind arimoclomol administration for an additional nine months after collection of primary data to gather additional secondary data. The primary endpoint will measure efficacy using the Revised ALS Functional Rating Scale, which is used to determine a patient's capacity and independence in 13 functional activities.

• ExonHit Therapeutics SA, of Paris, obtained regulatory approval to start a Phase II trial of EHT 0202 in Alzheimer's disease patients. The study is expected to enroll 135 patients and is designed to evaluate safety and tolerability of the product when administered orally for three months in conjunction with an acetylcholinesterase inhibitor as its primary endpoint. The study also will provide preliminary data on EHT 0202's efficacy, in particular regarding its effects on cognition and behavior.

• Genmab A/S, of Copenhagen, Denmark, said its partner, F. Hoffmann-La Roche Ltd., of Basel, Switzerland, initiated a Phase II trial of R1507 in recurrent or refractory sarcoma. The R1507 antibody was created by Genmab and will trigger a $500,000 milestone payment under the firm's agreement with Roche.

• InSite Vision Inc., of Alameda, Calif., started pivotal Phase III trials of AzaSite Plus in blepharoconjunctivitis, a frequently chronic inflammation of the conjunctiva and eyelids caused by infections or allergic reactions. The Phase III trials will test a total of about 800 patients, with dosing to consist of one drop in the eye and one on the eyelid two times per day for 14 days. The endpoints for product approval include lid margin redness, lid swelling, conjunctival redness, ocular discharge and discomfort symptoms. AzaSite Plus is formulated in InSite's DuraSite sustained delivery vehicle and is designed as a topical combination antibiotic/corticosteroid product.

• Intra-Cellular Therapies Inc., of New York, initiated a sleep maintenance insomnia (SMI) Phase II trial of ITI-722, a drug candidate designed to act predominantly as a selective 5-HT2A receptor antagonist. The study's primary endpoint is an assessment of objective slow wave sleep using polysomnography, and secondary endpoints include other objective and subjective measures of SMI and sleep efficiency. The study also will assess next-day cognitive performance.

• Introgen Therapeutics Inc., of Austin, Texas, said, based upon recommendations from external regulatory and clinical advisors, the company plans to include additional patient tissue samples from its Phase III trials for p53 biomarker analyses to predict Advexin efficacy to strengthen its U.S. and European regulatory filings. An additional 20 percent or more of biomarker data is expected to be captured through the effort. The company anticipates reporting top-line Phase III data and to submit filings for Advexin in head and neck cancer in the first half of 2008. Shares of Introgen (NASDAQ:INGN) fell $1.30, or 29 percent, Thursday to close at $3.22.

• Monogram Biosciences Inc., of South San Francisco, said partner Pfizer Inc., of New York, conducted a comparative study using Monogram's Trofile Assay vs. Malibu, Calif.-based Pathway Diagnostics' SensiTrop Assay, which concluded that the SensiTrop results were discordant with the results obtained using Trofile in trials of Pfizer's Selzentry (maraviroc). That drug, approved earlier this year in HIV, calls for the use of assays to determine which patients likely would benefit from the CCR5-blocker.

• Novavax Inc., of Rockville, Md., reported favorable interim results from a Phase I/IIa trial of its non-adjuvanted pandemic influenza virus-like particle (VLP) vaccine candidate. The initial stage of the study involves 70 healthy adults, ages 18 to 40, to receive two doses of either 15 mcg or 45 mcg of the H5N1 VLP vaccine or placebo and interim results indicated that the vaccine was well tolerated in all study groups. An independent data and safety monitoring board reviewed those data and recommended that Novavax proceed with the second stage of the study, in which safety and immunogenicity of a range of doses up to 90 mcg will be evaluated.

• YM BioSciences Inc., of Mississauga, Ontario, completed accrual in the first 50-patient cohort of its Phase II trial of nimotuzumab in combination with irinotecan in colorectal cancer. The firm reported that the safety profile to date is consistent with data from previous trials of nimotuzumab, a monoclonal antibody targeting the epidermal growth factor receptor, with no evidence of the severe side effects frequently seen with approved EGFR-targeting antibodies and small molecules. Preliminary data on disease control rates are expected to be available toward the end of the first quarter of 2008.

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