• Accera Inc., of Broomfield, Colo., said data from an open-label extension of its Phase IIb trial of AC-1202 (Ketasyn) in Alzheimer's disease confirmed earlier studies showing that the drug was safe and could significantly improve the memory and cognition of subjects with a certain pharmacogenomic profile. The randomized study involved 152 patients with mild to moderate Alzheimer's disease, with many continuing to take other drugs, such as cholinesterase inhibitors, to receive AC12-02 once-daily for three months. Following a two-week washout period, patients could participate in the six-month open-label portion of the trial. In the double-blind phase, patients receiving AC-1202 who were ApoE4-negative improved 3.5 points on the AD Assessment Scale-Cognitive (ADAS-Cog) score in 12 weeks compared to the placebo group, with statistical significant improvement seen in just 45 days. Data were presented at the Alzheimer's Association conference in Washington.

• ChemGenex Pharmaceuticals Ltd., of Melbourne, Australia, said data published in Leukemia demonstrated that a patient treated with Ceflatonin (homoharringtonine) experienced a 50 percent reduction of T315I Bcr-Abl levels within 2.5 months of treatment initiation and the complete disappearance of the mutation within 5.5 months of treatment. Shares of ChemGenex (NASDAQ:CXSP) fell 11.4 percent, or $1.43, to close at $11.10 on Tuesday.

• Critical Therapeutics Inc., of Lexington, Mass., said data from a pivotal Phase III clinical trial of Zyflo CR (zileuton) extended-release tablets were published in the June 2007 issue of the Journal of Asthma. The drug, a twice-daily leukotriene synthesis inhibitor for the prophylaxis and chronic treatment of asthma in adults and children 12 and older, was cleared by the FDA at the end of May.

• CuraGen Corp., of Branford, Conn., provided an update on several trials of its histone deacetylase (HDAC) inhibitor, belinostat. Interim data from a Phase II T cell lymphoma trial showed the drug as a monotherapy generated partial and complete responses, and CuraGen said both the CTCL and PTCL arms will be expanded. The company also expanded a Phase II ovarian cancer trial combining the drug with chemotherapy to include bladder cancer patients. A Phase II ovarian cancer monotherapy trial is enrolling patients and has generated an unconfirmed objective clinical response, while a Phase Ib/II solid tumor trial of the drug combined with chemotherapy achieved stable disease but no objective responses and is being expanded.

• Geron Corp., of Menlo Park, Calif., said its telomerase inhibitor cancer drug, GRN163L, has shown good pharmacokinetics and tolerability in its ongoing Phase I/II trial involving patients with chronic lymphocytic leukemia. Results were disclosed at the the Pan Pacific Lymphoma Conference in Maui, Hawaii. Geron's stock (NASDAQ:GERN) closed Tuesday at $7.82, down 91 cents.

• Idenix Pharmaceuticals Inc., of Cambridge, Mass., said results from a Phase II study of valopicitabine in combination with the standard-of-care treatment of pegylated interferon plus ribavirin in patients infected with the genotype-1 strain of the hepatitis C virus showed consistently higher rates of HCV PCR-negativity, defined as serum HCV RNA levels below 20 copies/mL, compared to the standard of care alone at every point analyzed in the study. Data from the 117-patient randomized study showed that, at 12 weeks, 72.2 percent of patients treated with the triple combination therapy were HCV PCR-negative per protocol, compared to 61.5 percent of patients treated with the standard of care. The study met its primary endpoint, demonstrating no pharmacokinetic or pharmacodynamic drug-drug interaction between valocitabine and ribavirin.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., reported data from the open-label extension portion of a Phase II study with pagoclone in persistent developmental stuttering. In the Phase II trial, patients on pagoclone experienced a mean reduction in the percentage of syllables stuttered of 18 percent, compared to 5 percent for the placebo group. In the first three months of the open label trial, the originally treated patients achieved a 40 percent reduction, while the originally-placebo group achieved a 31 percent reduction. Other efficacy measures were similarly improved in the open-label study over the double-blind trial. The data were presented at the 47th annual meeting of the New Clinical Drug Evaluation Unit.

• Neurogen Corp., of Branford, Conn., said data from a 48-subject Phase I study of NG2-73, its lead compound for insomnia, showed that 60 mg was the maximum tolerated dose, as defined by the depth of sedation, and the time to maximum concentration ranged from 0.33 to three hours. The half-life was 1.1 to 1.4 hours for all dosage groups, and NG2-73 exhibited linear increases in maximum concentration and area under the curve with increasing doses. In a separate 32-patient multiple-dose study, repeated dosing of the drug did not result in accumulation and it exhibited linear pharmacokinetics. Those data were presented at the SLEEP 2007 annual meeting in Minneapolis.

• Oscient Pharmaceuticals Inc., of Waltham, Mass., said results from the Phase III trial with the fluoroquinolone antibiotic Factive (gemifloxacin mesylate) tablets for the five-day treatment of community-acquired pneumonia of mild to moderate severity have been published in the July issue of the peer-reviewed Journal of Antimicrobial Chemotherapy. Data formed the basis for FDA approval last month for the five-day treatment of CAP.

• Penwest Pharmaceuticals Co., of Danbury, Conn., began a Phase IIa study of Nalbuphine ER, a nalbuphine hydrochloride extended-release tablet formulation being developed for pain. The randomized, double-blind, placebo controlled, 216-patient study will evaluate the analgesic efficacy of Nalbuphine ER in patients with chronic pain secondary to osteoarthritis of the knee or hip. Topline data are expected in the first quarter of 2008.

• Repros Therapeutics Inc., of The Woodlands, Texas, released top-line findings from its six-month study of Proellex in endometriosis, demonstrating that treatment with 50 mg of the product reduces both the duration and intensity of pain more effectively than 12.5-mg or 25-mg doses and is significantly better than Lucrin/Lupron (leuprolide, Abbott Laboratories) in reducing the number of days of pain over the course of the study. The trial enrolled 39 menopausal women and has completed six months of dosing. All doses of Proellex maintained estrogen concentrations in the low normal range, and there were no significant changes in biomarkers of bone resorption in any of the treatment arms at three and six months of treatment. Proellex is a progesterone receptor modulator that also is in development for uterine fibroids.

• 7TM Pharma A/S, of Horsholm, Denmark, initiated a double-blind, placebo-controlled, 180-patient Phase II trial of Obinepitide (TM30338) in obesity. Data from the trial, which will be conducted in Sweden, are expected in the first quarter of 2008. Obinepitide is an analogue of two hormones released in connection with food intake and has been shown in a Phase I/II trial to inhibit food intake.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., said updated results from the Phase IIb PROVE 2 study of the protease inhibitor telaprevir in hepatitis C virus showed efficacy and safety are generally consistent with PROVE 1, but the company held off providing specific virologic data until the American Association for the Study of Liver Diseases meeting in November. The company also disclosed completion of enrollment in PROVE 3, and still expects to start a Phase III program in the fourth quarter of this year. Vertex's stock (NASDAQ:VRTX) closed Tuesday at 26.89, down 28 cents.

• ViroPharma Inc., of Exton, Pa., said enrollment has been completed in the 500-mg BID arms of the ongoing Phase II study in hepatitis C patients with HCV-796, a unique orally dosed non-nucleoside hepatitis C viral polymerase inhibitor that interferes with the replication of the virus. The study is being conducted with Wyeth Pharmaceuticals Inc., a division of Wyeth, of Madison, N.J., ViroPharma's partner in development of HCV-796.