• Avant Immunotherapeutics Inc., of Needham, Mass., said that the National Institute of Allergy and Infectious Diseases Division of Microbiology and Infectious Diseases has agreed to sponsor a Phase I study of the firm's investigational single-dose, oral vaccine designed to offer combined protection against both enterotoxigenic Escherichia coli (ETEC) and cholera. The study, a randomized double-blind, placebo-controlled, inpatient Phase I trial of 64 adult volunteers, will examine the safety and immunogenicity of a single dose of the ETEC-Cholera vaccine, designated Peru-15 pCTB, at up to four escalating dose levels compared against placebo.

• Avicena Group Inc., of Palo Alto, Calif., said a dose evaluation study showed that 30 g was the optimum dose of its novel Huntington's disease treatment candidate HD-02. The study evaluated daily administration of HD-02 in doses ranging from 10 g to 40 g. Results showed that a 30-g dose provided the optimal levels of efficacy, safety and tolerability. The researchers also observed a slower cognitive decline and a sustained reduction in brain atrophy at the 30-g dose level. A double-blind, placebo-controlled Phase III clinical trial has been designed to evaluate the 30-g dose and its ability to slow functional decline. The trial will be sponsored by the National Center for Complementary and Alternative Medicine of the National Institutes of Health. Enrollment is expected to begin in the second half of 2008.

• Genentech Inc., of South San Francisco, said that results of a Phase II, open-label, randomized, noncomparitive clinical study showed that 36 percent of patients with glioblastoma multiforme (GBM) treated with Avastin (bevacizumab) alone and 51 percent of patients treated with Avastin in combination with irinotecan chemotherapy lived without the disease advancing within six months. In addition, preliminary estimates of tumor response were observed in 21 percent of patients treated with Avastin alone and in 34 percent of patients treated with Avastin in combination with chemotherapy. The study enrolled 167 patients with GBM whose cancer had relapsed after first- or second-line therapy. All patients had received prior temozolimide. Patients were randomized to receive Avastin alone or in combination with irinotecan every other week for up to 104 weeks.

• Keryx Biopharmaceuticals Inc., of New York, said that early results of a Phase II single-agent trial of perifosine (KRX-0401) in patients with malignant glioblastoma (GBM) and malignant anaplastic gliomas (AA) showed that the median progression-free survival (PFS) and overall survival in the anaplastic glioma group was nine weeks and 49 weeks, respectively. The study was designed to enroll at least 12 evaluable GBM patients and at least 10 evaluable AA patients. The study was to continue and enroll additional subjects if at least one patient achieved six month PFS. The firm said that the GBM arm has been halted and the AA arm will continue to enroll.

• OncoMethylome Sciences, of Liege, Belgium, announced positive clinical results from its colorectal cancer screening program. Interim clinical trial data showed that a panel of methylation markers detected colorectal cancer in blood samples collected from trial participants with 74 percent sensitivity and 92 percent specificity. The test's performance remained high, above 70 percent sensitivity, even when detecting early stage cancer. The data were presented at the Advances in Colon Cancer Research conference in Cambridge, Mass.

• Pacgen Biopharmaceuticals Corp., of Vancouver, Canada, said it has initiated a Phase IIb dose-ranging clinical trial for an optimized formulation of PAC-113, a 12 amino-acid antimicrobial peptide derived from a naturally occurring histatin protein found in human saliva. The study is a randomized, examiner-blinded, parallel design trial comparing three different doses of PAC-113 with Nystatin, a topical mouth rinse, as a treatment for oral Candidiasis infection.

• Quark Pharmaceuticals Inc., of Fremont, Calif., has begun dosing in humans for its proprietary product candidate, AKIi-5, a siRNA compound for the treatment of acute renal failure. The Phase I trial is a multicenter, double-blind, placebo-controlled, dose-escalation study assessing the safety and pharmacokinetics of AKIi-5 administered intravenously as a single dose to patients undergoing major cardiac surgery. Quark expects to complete the trial in early 2008.

• Raven Biotechnologies Inc., of South San Francisco, said an ongoing Phase I/IIa open-label, dose-escalation clinical trial of RAV12, its lead therapeutic antibody in development for the treatment of adenocarcinomas, showed that a fractionated dosing regimen allows delivery of RAV12 with an acceptable level of toxicity while maintaining exposure for a tumor response. RAV12 demonstrated preliminary evidence of antitumor activity, with one patient with refractory colorectal cancer experiencing a partial remission with time to progression exceeding eight months and one patient with advanced pancreatic cancer showing a >50 percent reduction in the relevant tumor marker, CA19-9 and experienced disease stability for more than five months. Future development of RAV12 both as single agent and in combination with chemotherapy is planned for 2008. The recommended dose and schedule for Phase II clinical study of RAV12 is 0.75 mg/kg twice weekly.

• Topigen Pharmaceuticals Inc., of Montreal, dosed the first patients in a Phase II trial of inhaled TPI 1020, an anti-inflammatory respiratory drug, in chronic obstructive pulmonary disease. The six-week trial is expected to enroll about 50 patients, with a primary endpoint of general safety and tolerability of TPI 1020 vs. budesonide, as well as TPI 1020's efficacy vs. budesonide on the change in sputum neutrophils counts between baseline and day 42. A secondary endpoint will measure the change in sputum neutrophil counts between baseline and day 21. Topigen licensed rights to TPI 1020 from NicOx SA, of Sophia Antipolis, France.

• TransMolecular Inc., of Cambridge, Mass., said that interim results of a Phase II for the intracavitary delivery of radiolabeled TM-601 (TM-601), synthetic version of chlorotoxin, a naturally occurring peptide derived from scorpion venom, in recurrent malignant glioma showed that the overall survival from the time of recurrence for the highest dosing regimen was estimated at 12.1 months, vs. nine months for the lowest dose group. Additionally, no dose-limiting toxicities were observed in the dose-escalation phase of the study.