• Ardea Biosciences, of Carlsbad, Calif., said it presented data demonstrating activity of the company's non-nucleoside reverse transcriptase inhibitor (NNRTI) family of compounds against HIV. The data showed that Ardea's lead NNRTI candidate, RDEA806, is a potent inhibitor of HIV, including the most common efavirenz-resistant viruses. Oral dosing with RDEA806 achieves trough levels in humans that average at least tenfold higher than the serum-adjusted EC50. No evidence of CNS toxicity or rash were observed in 74 subjects receiving RDEA806. A Phase IIa trial with the compound currently is enrolling, with data expected in the first quarter. Data were presented at the Conference on Retroviruses and Opportunistic Infections in Boston.
• Emisphere Technologies Inc., of Cedar Knolls, N.J., said positive results from recent animal studies showed that absorption of oral vitamin B12, using the company's proprietary eligen technology, was 15-30 times greater than with the same dose of oral vitamin B12 administered alone. The company plans to conduct clinical human trials beginning in the third quarter. Emisphere estimates that at least 5 million Americans are receiving B12 injections annually for a variety of medical conditions, and at least another 5 million are taking it in tablet form.
• Human Genome Sciences Inc., of Rockville, Md., and Xencor Inc., of Monrovia, Calif., have entered a collaboration under which Xencor will apply its XmAb humanization and optimization technologies to enhance monoclonal antibodies developed by HGS that specifically target antigens discovered by HGS. Under the terms of the agreement, Xencor will receive an up-front payment and is eligible to receive additional payments including development and commercial milestones, and royalties on any products commercialized under the agreement. Specific terms were not disclosed. HGS will be responsible for all preclinical and clinical development, manufacturing and commercialization. Financial terms were not disclosed.
• Monogram Biosciences Inc., of South San Francisco, said data related to the company's advanced HIV tropism assay have been presented in multiple posters during the Conference on Retroviruses and Opportunistic Infections in Boston. The first presentation analyzed subjects from the AIDS Clinical Trials Group 5211 study and compared co-receptor tropism results (R5, X4 or dual/mixed DM HIV) of the original Trofile test with those obtained using an enhanced version of the assay. Researchers found that the enhanced Trofile assay would have further optimized patient selection for the new drug class by successfully identifying patients with low levels of DM (non-R5) HIV at screening and patients who subsequently experienced treatment failure on a CCR5 antagonist. Data from the other presentations showed specific markers of HIV resistance to CCR5 antagonists, particularly the role that mutations in the V3 loop play.
• Nara Biosciences Inc., of Boston, said it has completed an agreement with Boston University to license the genetically engineered MyoMouse for developing therapies for muscle wasting disorders and diseases of aging. The exclusive license includes all commercial rights to therapeutic factors discovered using the MyoMouse. Nara said it intends to develop new proteins produced in the MyoMouse, such as myokines, for a variety of metabolic and muscle wasting disorders, either independently or in collaboration with strategic partners.
• Oscient Pharmaceuticals Corp., of Waltham, Mass., said it received notice from Nasdaq that the company was in full compliance with all requirements for continued listing. The company had been cited for not complying with requirements for $50 million in total assets and $50 million in total revenues.
• Pharmion Corp., of Denver, said the European Medicines Agency has accepted for review the company's marketing authorization application for Vidaza (azacitidine for injection) in patients with higher-risk myelodysplastic syndromes, and will review the application under the accelerated assessment procedure. Accelerated assessment is granted for products that are expected to be of major public health interest. Vidaza has been designated as an orphan medicinal product in the EU for the treatment of MDS.
• Profectus BioSciences Inc., of Baltimore, has named Shawn Patrick O'Brien company president and CEO. O'Brien also will serve as a director of the company. O'Brien comes from Solstice Neurosciences Inc., where he served as president and CEO since 2004.
• Tissue Therapies Ltd., of Brisbane, Australia, said it has been granted ethics approval to proceed with the human clinical trial of VitroGro, a wound healing product for the treatment of diabetic and venous ulcers. The trial is set to begin later in February.