• Alseres Pharmaceuticals Inc., of Hopkinton, Mass., said it reached agreement with the FDA for a special protocol assessment for a Phase III study of its Altropane molecular imaging agent to aid in the early diagnosis of Parkinsonian syndromes, including Parkinson's disease. The study, designated POET-2 (Parkinson's or Essential Tremor), is designed to confirm the diagnostic utility of Altropane in anticipation of drug registration and includes two parallel studies enrolling up to 480 subjects in total. Altropane is designed to specifically and selectively bind to the dopamine transporter found on dopamine-producing neurons.

• Avineuro Pharmaceuticals Inc., of San Diego, said it started Phase I studies of AVN-101, a small molecule for Alzheimer's disease. Results are expected to be available in May, and if positive, the company plans to advance the program into Phase II trials later this quarter.

• Deciphera Pharmaceuticals LLC, of Lawrence, Kan., said it started a Phase I trial of DCC-2036, a Bcr-Abl kinase inhibitor, in patients with treatment-resistant or intolerant Philadelphia chromosome-positive chronic myeloid leukemia or acute lymphoblastic leukemia, including patients with the T3151 gatekeeper amino acid mutation.

• Genta Inc., of Berkeley Heights, N.J., said it completed patient enrollment in a Phase III trial of Genasense (oblimersen sodium) injection in advanced melanoma, with final accrual reaching 315 patients. The AGENDA study is designed to confirm safety and efficacy results obtained in a prior trial of Genasense combined with dacarbazine in patients who previously have not received chemotherapy. The trial employs a biomarker to define those patients who derived maximum clinical benefit during the preceding study. Genta, which started the trial in 2007, estimates that the final assessment of progression-free survival will be analyzed about six months after the last patient has been enrolled. (See BioWorld Today, Aug. 22, 2007.)

• Glycotex Inc., of Rockville, Md., said it completed a scheduled interim analysis of a Phase II trial of GLYC-101 gel in complete wound closure and cosmetic outcomes in surgery patients undergoing carbon dioxide laser skin resurfacing on the lower eyelid area. The comparison of each active arm to placebo with respect to the primary endpoint of time to complete wound closure showed positive results when considering the full dataset of patient data from all treatment combinations. The ongoing study is expected to enroll about 48 patients who are randomized to receive either GLYC-101 or placebo gel on one lower eyelid and a different test article on the other lower eyelid applied topically to the laser-ablated area.

• Intercell AG, of Vienna, Austria, said it began a Phase I trial of vaccine candidate IC47 to prevent disease caused by the bacterium Streptococcus pneumoniae. The vaccine is a recombinant subunit vaccine consisting of three conserved surface proteins from S. pneumoniae, two of which were discovered by Intercell, while the third was in-licensed from the Centers for Disease Control and Prevention. The study is expected to enroll 32 subjects to test two different vaccine concentrations either with or without the addition of an adjuvant.

• Mithridion Inc., of Madison, Wis., reported results from a Phase I study of MCD-386, its lead candidate for Alzheimer's disease, showing that the drug was well tolerated at low doses in healthy volunteers, with no adverse drug-related events reported. Serum drug concentrations were measured successfully in the 18 subjects receiving MCD-386, and pharmacokinetic parameters showed that the drug was rapidly absorbed, reaching maximum serum concentrations in one hour to 1.5 hours. The mean serum half-life was about 1.4 hours. MCD-386 is an M1 selective muscarinic agonist aimed at improving memory and cognition and for disease-modifying effects in Alzheimer's.

• Oncolytics Biotech Inc., of Calgary, Alberta, reported positive results from its UK Phase II trial of Reolysin in objective tumor response rate in combination with low-dose radiation in patients with advanced cancer, showing that 13 of 14 evaluable patients had stable disease or better in the treated target lesions. Of those, partial responses were observed in four patients and minor responses were seen in two patients, for a total disease control rate of 93 percent. The combination was well tolerated, with only mild toxicities noted.

• Serentis Ltd., of Cambridge, UK, said it started patient recruitment in a Phase II trial of SRD441 in atopic dermatitis. The 28-day study is designed to measure acute efficacy, as defined by the Investigators' Global Assessment. Results are expected later this year.