• Antisense Pharma GmbH, of Regensburg, Germany, said data from a Phase IIb trial in anaplastic astrocytoma showed its AP 12009 as a monotherapy was superior to temozolomide. The TGF-beta 2 inhibitor was studied in 134 patients with recurrent high-grade glioma, 39 of them with AA. The company said the response rate for AP 12009 in AA patients steadily increased in the course of 14 months, whereas in the chemotherapy treatment arm a transient peak of the response rate at six months was not sustainable and decreased to zero at 14 months. It said efficacy was reflected by the prolonged median survival times for both AP 12009 treatment groups, as compared to the control group in the AA patients. The company also reported positive preliminary data from a Phase I/II trial of AP 12009 in advanced pancreatic carcinoma, metastatic melanoma and advanced colorectal carcinoma.

• Arpida Ltd., of Basel, Switzerland, has received approval from the FDA for a Phase II trial with intravenous iclaprim in the treatment of patients with hospital-acquired pneumonia, ventilator-associated pneumonia or healthcare-associated pneumonia suspected or confirmed to be due to Gram-positive pathogens. The multi-center, randomized, double-blind, comparative study will study the efficacy and safety of two different dosing regimens compared to the current standard of care vancomycin. More than 130 patients will be enrolled, starting in the second half of 2007. The primary endpoint will be the clinical cure rate at the time of care visit.

• Corcept Therapeutics, of Menlo Park, Calif., said top line results from a proof of concept study indicate a statistically significant reduction in weight gain in subjects who took olanzapine plus Corlux compared to those who took olanzapine alone. In the two-week study, subjects in the olanzapine alone group gained an average of 2.5 pounds more than subjects in the olanzapine plus Corlux group and 2.2 pounds more than subjects in the Corlux alone group, statistically significant differences (p < .001). No unexpected adverse events were seen in any group, but a complete review of all safety data has not yet been completed.

• GenVec Inc., of Gaithersburg, Md., said the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases, has begun a Phase I clinical trial to test a vaccine Ad35HIV-EnvA to prevent HIV-1 infection. This adenovector-based vaccine was developed under a collaborative research and development agreement between GenVec and the center. The two-part study will evaluate the safety, tolerability and immunogenicity of Ad35-EnvA in comparison to and in combination with the Ad5-EnvA vaccine in prime-boost schedules. The first part of the study, a dose-escalation evaluation, will involve 15 healthy adult volunteers. The second phase of the study is designed to test prime-boost combinations of Ad5- and Ad35-based vaccines.

• Intra-Cellular Therapies Inc., of New York, has initiated Phase I clinical trials for ITI-007, its first-in-class dual 5HT2A receptor antagonist/dopamine receptor phosphoprotein modulator (DPPM) for the treatment of schizophrenia, and ITI-722, a low dose formulation of ITI-007 with selective 5HT2A receptor antagonist properties for the treatment of sleep maintenance insomnia. The studies are to determine the pharmacokinetics, safety, and maximum tolerated dose of ITI-007 in healthy volunteers as a prelude to efficacy studies for the treatment of acute psychotic symptoms in patients with schizophrenia and for the treatment of sleep maintenance insomnia. Both ITI-007 and ITI-722 are part of a portfolio of compounds licensed from Bristol Myers Squibb Co.

• Kinex Pharmaceuticals LLC, of Buffalo, N.Y., filed its first investigational new drug application with the FDA. The IND covers KX2-391 (KX01), a small-molecule anticancer product candidate. The oral agent, Kinex said, is a highly selective Src kinase inhibitor that targets the peptide substrate binding site, not the ATP binding site as do other Src inhibitors. The Phase I open-label, dose-escalation study of KX2-391 is expected to include patients with all types of solid tumors and lymphoma. It is designed to measure pharmacokinetics, safety and tolerability, and is expected to begin in September.

• LifeCycle Pharma, of Horsholm, Denmark, will initiate a Phase II clinical trial of LCP-Tacro for the prevention of organ rejection in kidney transplant patients following an update of its initial investigational new drug application to the FDA. The trial is a conversion study in stable kidney transplant recipients, with patients being switched to LCP-Tacro once-a-day from Prograf twice-a-day. Up to 60 patients will be enrolled at sites in the U.S. and Canada. The initial clinical trial results are expected by the end of this year or early 2008. The study is the basis for initiation of a subsequent Phase III program in de-novo kidney transplant recipients.

• Neurochem Inc., of Laval, Quebec, received a third recommendation from the European Data Safety Monitoring Board to continue its ongoing European, 18-month, Phase III clinical trial for Alzhemed (tramiprosate) for Alzheimer's disease. This recommendation by the DSMB members was based on their recent review of the available safety data from 747 patients who have been on study medication for an average of 5.7 months. The drug is a small, orally administered amyloid beta antagonist.

• Opexa Therapeutics Inc., of The Woodlands, Texas, disclosed positive top-line data in an open-label Phase I/II extension trial of the T-cell vaccine, Tovaxin for multiple sclerosis. In the one-year, eight-subject extension clinical trial of relapsing remitting and secondary progressive subjects, Tovaxin therapy was shown to be safe and effective. The per-protocol analysis achieved a 92 percent reduction in annualized relapse rate in subjects who received two treatment doses of 30 - 45 x 106 attenuated T-cells eight weeks apart and were monitored for 44 more weeks. Subjects in the extension study had previously been treated an average of 5.2 1.8 (1, 8; median 5.4) years earlier at Baylor College of Medicine with a T-cell vaccine developed from myelin basic protein reactive T-cells. The safety profile revealed only injection site mild reactions and no severe adverse reactions related to T-cell vaccination.

• Panacos Pharmaceuticals Inc., of Watertown, Mass., reported positive preliminary results from the 250 mg cohort of a Phase IIb study of bevirimat (PA-457) in patients failing HIV therapy due to drug resistance. Bevirimat plasma concentrations and antiviral effect were approximately double those seen in the first Phase IIb cohort that had used a suboptimal tablet formulation, the company said. No safety or tolerability issues arose, consistent with previous clinical experience. The results of the 250 mg cohort support further dose escalation to explore the dose-response relationship of bevirimat, the company said. The company said the lower than expected plasma concentrations observed in the earlier 400 mg tablet trial were caused by the prototype tablet formulation, and not by bevirimat itself. The company expects to complete a 300 mg dose study in the third quarter of 2007.

• S*BIO Pte. Ltd., of Singapore, started a Phase I clinical trial with the anti-cancer compound SB939, a histone deacetylase inhibitor. The Phase I trial of SB939 is a dose-escalation study and is currently conducted at the Department of Hematology-Oncology, in the Cancer Institute at National University Hospital in Singapore. This study will evaluate the safety and tolerability, as well as determine the pharmacokinetic and pharmacodynamic profile of SB939 in cancer patients with solid or hematological tumors. SB939 has been found to be well tolerated in the first cohort of patients and the dosing continues with the next dose-groups.

• Surface Logix Inc., of Boston, has initiated a Phase IIa clinical trial to test the safety, tolerability and pharmacodynamics of orally administered SLx-2101 in patients with hypertension. SLx-2101 is a long-acting PDE-5 inhibitor designed to deliver efficacy in a range of cardiovascular diseases, which were originally viewed as obvious therapeutic targets for PDE-5 inhibition, including hypertension. The trial is a randomized, double-blind, placebo-controlled crossover study being conducted at two centers in Europe, and is expected to enroll 40 patients who will receive 5mg or 10mg oral doses of SLx-2101 once daily for up to 14 days. The study objectives are to determine the effect of SLx-2101 on placebo-corrected, office-seated peripheral systolic and diastolic blood pressure, as well as on home monitored blood pressure.

• Theravance Inc., of South San Francisco, has enrolled the last patient in its Phase III clinical study of the investigational antibiotic telavancin in patients with hospital-acquired pneumonia due to gram-positive bacteria, including resistant strains such as methicillin-resistant Staphylococcus aureus. Telavancin is currently under regulatory review in both the U.S. and Europe for the treatment of complicated skin and skin structure infections caused by gram-positive bacteria.

• Vivus Inc., of Mountain View, Calif., completed an end of Phase II meeting with the FDA related to Qnexa for obesity. The Phase III program will be designed to dose patients for 56 weeks (inclusive of a 4-week titration period) and will enroll about 4,500 patients in the placebo-controlled pivotal studies. The company expects to study obese patients (body mass index>30) and obese patients with associated co-morbidities (BMI>27), such as Type 2 diabetes, hypertension and dislipidemia. The primary endpoint in the obesity studies will be the proportion of patients who lose at least 5 percent of their body weight, as well as a range of secondary endpoints including absolute weight loss and the proportion of patients who lose over 10 percent of their body weight compared to placebo. The company currently is preparing a special protocol assessment request. Qnexa incorporates low doses of active ingredients from two previously FDA-approved products, phentermine and topiramate.