Aida Pharmaceuticals Inc., of Hangzhou, China, successfully concluded Phase I trials for its gene therapy antitumor drug Rh-Apo2L. The studies, which included 20 patients with different cancers, found that the drug reduces tumor size of non-Hodgkin's lymphoma, sarcoma and adrenal gland cortical tumors, and has an effect on other tumor types. The company plans to apply for Phase II and Phase III trials, and said it anticipates completing all trials by the end of next year for potential

Allos Therapeutics Inc., of Westminster, Colo., said the FDA conferred orphan drug status to PDX (pralatrexate), the company's next-generation antifolate for T-cell lymphoma. Allos plans to begin a Phase II study of PDX in patients with relapsed or refractory peripheral T-cell lymphoma this quarter. Cytogen Corp., of Princeton, N.J., said Quadramet (samarium Sm-153 lexidronam injection) is part of a Phase III trial to evaluate its ability to treat osteoblastic metastases arising from lung

Acologix Inc., of Hayward, Calif., said results from a 40-patient Phase II feasibility study of AC-100 in periodontal defects demonstrated a favorable safety profile but the drug did not significantly regenerate more periodontal bone vs. placebo. The company believes the dose evaluated in the study exceeded what might be the optimal dose and intends to conduct additional Phase II studies to determine appropriate dosing. AC-100 is a synthetic peptide derived from an endogenous human protein

AVI BioPharma Inc., of Portland, Ore., plans to fill two new cohorts of patients to extend the duration of treatment with AVI-4065 in its hepatitis C virus clinical trial. One cohort will be treated twice daily for 28 days, and the second will receive therapy twice daily for 56 days. The extension of the treatment duration from 14 days to 28 days and 56 days is the first of several variables that the company is considering to potentially enhance the pharmacokinetics and viral and clinical

Amazon Biotech Inc., of New York, signed an interim letter of agreement with the Immunology Clinic of New York to conduct a Phase I/II, randomized, double-blind, placebo-controlled study to test the safety and efficacy of its botanical drug product, AMZ0026, in pre-symptomatic HIV-positive patients undergoing no other anti-retroviral therapies

Aegis Therapeutics LLC, of San Diego, completed its first clinical study, a 10-patient, three-way crossover trial, designed to confirm the effectiveness of Intravail absorption enhancement agents in increasing intranasal bioavailability of peptide and protein drugs. The study revealed an average systemic bioavailability of about 35 percent for the Intravail formulation of a marketed drug, compared to an average of 7 percent for the identical commercial formulation without Intravail. Aegis

Acadia Pharmaceuticals Inc., of San Diego, said results from three clinical studies demonstrated that ACP-104 is safe and well tolerated after repeated dosing of up to 600 mg per day in 74 schizophrenics, and initial signals of antipsychotic effects were observed within its tolerated dose range. In addition, plasma levels of ACP-104 correlate with brain receptor occupancies indicating good penetration into the brain. The product, also called N-desmethylclozapine, is the major metabolite of

Computer Sciences Corp., of El Segundo, Calif., said DynPort Vaccine Co. LLC, of Frederick, Md., has entered a Phase II trial for its recombinant plague vaccine candidate, rF1V. The study will test different vaccine dosages and schedules in 400 healthy volunteers between the ages of 18 and 55. The clinical trial is under way and will continue into 2007 at eight locations across the U.S. Cougar Biotechnology Inc., of Los Angeles, enrolled the first patient in a Phase I trial of CB7630

BioMimetic Therapeutics Inc., of Franklin, Tenn., completed enrollment in its Canadian pilot study with its lead candidate, GEM OS1 Bone Graft. As a result of the preliminary data obtained, the company received authorization from the Canadian government to expand the study from 20 patients to up to 60. BioMimetic hopes to file for Canadian registration for orthopedic indications in 2007. The company also has completed enrollment in its U.S. pilot study for foot and ankle fusions and its Swedish

Avicena Group Inc., of Palo Alto, Calif., said a Phase II trial was initiated of two combination therapies incorporating ALS-08, a candidate for amyotrophic lateral sclerosis. Investigators will assess ALS-08 in separate combinations with celecoxib and minocycline. The six-month, multicenter, double-blind controlled trial will enroll up to 120 ALS patients, and the primary endpoint is the change in the revised ALS Functional Rating Scale. Baxter International Inc., of Deerfield, Ill., started

They are the first of the company's programs to enter the clinic and are part of DanioLabs' focus on improving the quality of life of patients with intractable neurological conditions

Aastrom Biosciences Inc., of Ann Arbor, Mich., said it completed the patient accrual and treatment portion of its U.S. Phase I/II multicenter long bone fracture trial using its cell-based Tissue Repair Cells (TRCs) for tissue regeneration on all 36 patients enrolled. The trial is evaluating the use of TRCs - a mixture of stem, stromal and progenitor cells derived from the patient's bone marrow - in the treatment of severe fractures that have failed prior treatment interventions. Acologix Inc

Adventrx Pharmaceuticals Inc., of San Diego, said a study found that peak plasma levels of drug from a two-hour infusion of 60 mg/m2 CoFactor were similar to bolus administration and should be sufficient for biological effect. A Phase IIb trial is ongoing using CoFactor plus 5-FU in an infusional regimen for first-line treatment of metastatic colorectal cancer. Data were presented at the 8th World Congress on Gastrointestinal Cancer in Barcelona, Spain. Adventrx also reported encouraging

Separate results showed that after intranasal administration, formulations containing a single peptide or pegylated peptide permeation enhancer produced similar or better bioavailability of the therapeutic peptide in the bloodstream than formulations using multiple small-molecule excipients, which previously have demonstrated enhanced bioavailability in the clinic

Avera Pharmaceuticals Inc., of San Diego, completed a Phase II study of gantacurium chloride as an adjunct to general anesthesia to enable rapid intubation of patients undergoing surgery. Gantacurium chloride is a new, non-depolarizing ultra-short acting neuromuscular blocker. The study was designed to evaluate the product in healthy adult patients undergoing endotracheal intubation prior to surgery under general anesthesia. It enrolled 230 subjects. The study achieved greater than 90 percent

Adventrx Pharmaceuticals Inc., of San Diego, said an independent data safety monitoring board recommended that a Phase IIb study of CoFactor (ANX-510) continue without any modifications after a planned interim analysis. CoFactor is a folate-based biomodulator drug designed to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-fluorouracil (5-FU). The evaluation was based on data from 150 patients, half of the planned total. Antares Pharma

Amazon Biotech Inc., of New York, negotiated a Phase I/II protocol with the FDA, allowing the company to start a trial of AMZD026 in HIV patients. The trial will test the safety, immunological and antiviral effects of the product. The double-blind, placebo-controlled study involves 32 non-symptomatic HIV subjects who have yet to be treated with highly active anti-retroviral therapy. Avigen Inc., of Alameda, Calif., plans to begin clinical development of AV650 in the second half of this year

Acceleron Pharma Inc., of Cambridge, Mass., initiated a Phase I trial of ACE-011, a regenerative therapeutic for bone loss disease, particularly osteoporosis. The study will involve healthy postmenopausal women and will evaluate a single ascending dose for safety, tolerability and pharmacology properties. ACE-011 is based on the activin receptor IIa, and has demonstrated in preclinical models beneficial effects on both trabecular and cortical bone. Adnexus Therapeutics Inc., of Waltham, Mass

Actelion Ltd., of Allschwil, Switzerland, reported a preliminary analysis of its 413-patient, Phase IIb dose-finding study showing that its intravenous clazosentan reached statistical significance vs. placebo at all three doses tested - 15 mg/hour, 5 mg/hour and 1 mg/hour. All met the primary endpoint of reducing the occurrence of moderate or severe cerebral vasospasm, as measured by cerebral angiography at day nine post-aneurysm rupture compared to placebo. However, results also showed a lack