• AlphaVax Inc., of Research Triangle Park, N.C., concluded a Phase I study in 216 healthy volunteers of an influenza vaccine based on its replicon vector platform, and found the vaccine, administered either subcutaneously or intramuscularly at two dosage levels, to be safe and well tolerated. The vaccine is comprised of a replicon vector expressing the hemagglutinin gene derived from the A/Wyoming (H3N2) flu strain. Results also showed that both antibody and T-cell responses were efficiently stimulated and persisted for the duration of the four-month study. Additional clinical studies of AlphaVax' replicon vaccines for infectious disease, biodefense and cancer indications are planned for 2008.

• Amylin Pharmaceuticals Inc., of San Diego, Eli Lilly and Co., of Indianapolis, and Alkermes Inc., of Cambridge, Mass., said results from a 30-week comparator study showed a statistically significant improvement in A1C levels of about 1.9 percentage points from baseline in patients receiving an investigational formulation of once-weekly exenatide long-acting release compared with an improvement of about 1.5 percentage points for Byetta (exenatide). About three out of four subjects treated with once-weekly exenatide achieved an A1C of 7 percent, the target for good glucose control as recommended by the American Diabetes Association, or less. After 30 weeks of treatment, both once-weekly exenatide and Byetta treatment resulted in an average weight loss of about 8 lbs. Amylin, Lilly and Alkermes are developing exenatide long-acting release injection to treat Type II diabetes based on Alkermes' proprietary injectable long-acting release technology. The companies anticipate a regulatory submission to the FDA by the end of the first half of 2009.

• Apthera Inc., of Scottsdale, Ariz., said it held a positive end-of-Phase II meeting Aug. 29 with the FDA about breast cancer therapy NeuVax. Based on the meeting, Apthera plans to submit a finalized clinical protocol to the FDA under a special protocol assessment and expects to start a Phase II/III registration trial in the first half of 2008. NeuVax is a HER2/neu peptide-based T-cell immunotherapy aimed at preventing disease recurrence and prolonging survival in cancer patients who have tumors which express the HER2/neu oncoprotein. To date, clinical study results have shown that NeuVax significantly reduces the rate of cancer recurrence while showing minimal side effects.

• ArQule Inc., of Woburn, Mass., has begun two Phase II trials with ARQ 197, an orally administered, small molecule inhibitor of the c-Met receptor tyrosine kinase, in patients with MiT (Microphthalmia Transcription Factor) tumors and pancreatic cancer. During the first stage of the trial, approximately 23 patients will be treated with 120 mg of ARQ 197 orally twice daily. If a partial response or a complete response is observed in more than one patient in that stage, the study will be continued to the second stage, where an additional 22 patients will be enrolled. Otherwise, the study will be stopped.

• Collegium Pharmaceutical Inc., of Cumberland, R.I., said it would accelerate development of COL-003, its abuse deterrent, sustained-release, oral oxycodone formulation, following successful completion of a proof-of-concept trial. Topline results showed the formulation exhibited controlled-release pharmacokinetic characteristics with plasma concentrations measurable throughout a 24 hour period; was bioequivalent to Oxycontin under fed conditions; its bioavailability as measured by Cmax, and AUC was similar when dosed intact or after opening the capsule, emptying the contents in the mouth and chewing prior to swallowing; and its bioavailability was decreased when dosed to fasting subjects, relative to fed subjects.

• GenVec Inc., of Gaithersburg, Md., reported encouraging early results of a Phase II study with TNFerade in patients with locally advanced rectal cancer. The Phase II study enrolled seven patients with locally advanced rectal cancer who were given TNFerade weekly via intratumoral injections during the first five weeks of radiotherapy. Surgical removal of the tumor was done six to nine weeks following therapy. The treatment was both feasible and appeared to be well tolerated. Prior to treatment, four of the seven patients were classified as highly likely to need sphincter-removing surgery with colostomy. Subsequent to TNFerade plus chemoradiation, all seven patients who underwent surgical resection had successful sphincter sparing procedures. Five of the seven patients achieved pathological complete response. Based on those preliminary data, the NCI study is continuing to enroll more patients

• Manhattan Pharmaceuticals Inc., of New York, said the first patient has received the initial dose in the Phase IIa clinical study of the company's lead product candidate, topical PTH (1-34), for the treatment of psoriasis. The U.S. multicenter, randomized, double-blind, vehicle-controlled, parallel group study is designed to evaluate safety and preliminary efficacy of topical PTH for the treatment of psoriasis. About 54 subjects will be enrolled and randomized to receive one of two dose levels of topical PTH or vehicle for an eight-week treatment period. The vehicle in the study is the topical formulation without the active ingredient, PTH, an agonist believed to mimic a natural protein responsible for regulating the growth of skin cells.

• MAP Pharmaceuticals Inc., of Mountain View, Calif., said it has initiated a Phase IIa trial evaluating MAP0005, a combination of a corticosteroid and a long-acting beta-2-agonist, for the potential treatment of asthma and chronic obstructive pulmonary disease. The trial is a randomized, open-label, active-controlled, crossover, safety and dose response Phase IIa study investigating the pharmacokinetics and pharmacodynamics of MAP0005 in about 18 adult patients with asthma. The trial compares two different doses of MAP0005 with one dose of a commercially marketed combination product, all administered by inhalation. The primary endpoints are the change in forced expiratory volume in one second (FEV1) from baseline, the time to maximum change in FEV1 and the plasma levels for the inhaled corticosteroid.

• Palatin Technologies Inc., of Cranbury, N.J., has initiated dosing in a Phase I trial of PL-3994, a long-acting analogue of atrial natriuretic peptide, under development for treatment of acute decompensated congestive heart failure. The trial, being conducted under an investigational new drug application, is a randomized, double-blind, placebo-controlled, single-ascending dose study in healthy volunteers who will receive the drug subcutaneously. The evaluations will include safety, tolerability, pharmacokinetics and several pharmacodynamic endpoints, including endogenous messenger levels such as cyclic guanosine monophosphate.

• Revotar Biopharmaceuticals AG, of Hennigsdorf, Germany, reported positive results from an investigator-driven open labeled Phase IIa pilot study in 14 patients with stable COPD stage 0 to II (GOLD criteria) inhaling 70 mg of Bimosiamose twice a day. The analysis of induced sputum prior to and after Bimosiamose treatment of nine days showed that both relative and absolute lymphocytes count decreased significantly. In addition, sputum IL-8 was significantly decreased. Bimosiamose already has passed several clinical Phase I and Phase IIa trials in asthma and psoriasis.

• TransMolecular Inc., of Cambridge, Mass., reported positive interim Phase I data for its intravenous formulation of I-TM-601 in recurrent glioma. The Phase I study demonstrated that intravenously administered radiolabeled TM-601 is able to cross the blood-brain barrier, bind to tumor tissue in the brain, and produce MR imaging improvement in patients with inoperable malignant glioma. The data were presented in a poster at the American Society for Therapeutic Radiology and Oncology meeting in Los Angeles.

• Vanda Pharmaceuticals Inc., of Rockville, Md., said that data from a proof-of-concept Phase II trial showed its investigational compound for narcolepsy, VSF-173, did not reach statistical significance for wakefulness. The trial examined VSF-173 on a model of excessive sleepiness in 55 healthy volunteers treated with three doses of VSF-173 administered at 50 mg, 100 mg and 200 mg and placebo administered at 25 mg, 50 mg and 100 mg at bedtime and at four hours after the first dose. On the primary endpoint which evaluated the effect of the compound on the first four series of maintenance of wakefulness tests (MWT), VSF-173 demonstrated improvements over placebo, the firm said. The mean MWT sleep onset scores for the 50 mg, 100 mg and 200 mg, and placebo groups were 10.3, 12.9, 10.6 and 9.2 minutes, respectively. The magnitude of effect, ranging from 1.1 to 3.7 minutes, is similar to that observed with modafinil in the treatment of patients with narcolepsy, the company said.