• Avigen Inc., of Alameda, Calif., said it received FDA approval to proceed with U.S. clinical development of AV411 (ibudilast), an orally bioavailable small-molecule glial cell attenuator. The initial U.S. trial for AV411 will be a Phase I maximum-tolerated-dose study designed to build on data from Phase I and exploratory Phase IIa studies in Australia. The study in 48 volunteers is designed to assess safety and tolerability, as well as the effect of food on AV411 pharmacokinetics and tolerability. The product is being developed to treat neuropathic pain and other indications such as opioid withdrawal and dependence. Ibudilast already is approved in Asia at doses up to 30 mg per day.

• BioMarin Pharmaceutical Inc., of Novato, Calif., said final results from the Kuvan (sapropterin dihydrochloride) pivotal Phase III trial were published in the Aug. 11, 2007 issue of The Lancet. The study suggested treatment with Kuvan results in significant reductions in blood Phe levels in some phenylketonuria patients. The small-molecule product is being developed with Merck Serono, a division of Merck KGaA, of Darmstadt, Germany. The FDA recently granted priority-review status to the orphan product. BioMarin said it hoped to receive FDA approval by late November.

• Oragenics Inc., of Alachua, Fla., said the FDA placed a clinical hold on a proposed Phase Ib safety study of its SMaRT Replacement Therapy for the prevention of dental cavities. The technology is a topical treatment, based on a genetically modified strain of Streptococcus mutans, designed to offer protection from most tooth decay. The company said it expects to address the remaining issues and submit a complete response to the clinical hold letter within 30 days.

• Pervasis Therapeutics Inc., of Cambridge, Mass., said it completed patient recruitment for its two Phase II trials of Vascugel, an allogeneic cell therapy product that may restore natural repair and regeneration pathways in traumatized human vasculature. The Phase II studies are to evaluate continued safety of Vascugel as well as its efficacy in the maintenance of vascular patency after creation of arteriovenous access grafts and AV fistulae in patients undergoing dialysis for treatment of end-stage renal disease.

• pSivida Ltd., of Perth, Australia, completed the recruitment stage of it Phase IIa study of BrachySil for the treatment of inoperable pancreatic cancer, at hospitals in the UK and Singapore. Seventeen patients were treated with BrachySil directly to a tumor in the pancreas via endoscopic ultrasound (used to assist in locating the delivery point), in combination with standard chemotherapy. BrachySil consists of a combination of BioSilicon, a modified form of silicon, and the isotope 32Phosphorus, intended to be used with standard chemotherapy for enhanced tumor response.