• Access Pharmaceuticals Inc., of Dallas, began a third oral drug delivery research collaboration. It is aimed at combining Access's vitamin B12 oral drug delivery technology with the potential Alzheimer's disease treatment drug oligotropin owned by Hunter-Fleming Ltd. in the UK. Access' scientists have found that the attachment of vitamin B12 to drugs, polymers containing drugs, as well as drugs encapsulated within nanoparticles, provides formulations that are absorbed into the body using the vitamin B12 uptake mechanism.

• Adherex Technologies Inc., of Research Triangle Park, N.C., initiated a Phase Ib/II clinical trial of ADH-1 (Exherin) at the M.D. Anderson Cancer Center in Houston in advanced cancer patients who express the tumor molecular target N-cadherin. The study is designed to define the maximum tolerated dose and to evaluate the safety, tolerability and antitumor activity of repeated and ascending doses of ADH-1. The trial is expected to enroll about 40 patients.

• BioMarin Pharmaceutical Inc., of Novato, Calif., named Jean-Jacques Bienaime as its new CEO and a member of the board. Bienaime last served as chairman, CEO and president of Genencor International Inc., of Palo Alto, Calif.

• FASgen Inc., of Baltimore, reported that results of recent studies demonstrate that FAS20013, the company's compound for tuberculosis and MDR-TB, is both bactericidal and has a sterilizing effect against rifampin-tolerant bacteria. FAS20013 proved to be bactericidal against anaerobically adapted Mycobacterium bovis BCG in the Wayne Model. It killed anaerobically adapted BCG at concentrations ranging from 1.5 micrograms/ml to 50 micrograms/ml. FAS20013 also demonstrated sterilizing activity against rifampin-tolerant persisters, with an average reduction in viable cells of 1.5 log at all concentrations tested.

• Galapagos NV, of Mechelen, Belgium, and Asinex Ltd., of Moscow, initiated a drug discovery collaboration in bone and joint diseases. The collaboration will result in a set of optimized leads for Galapagos' validated bone and joint disease drug targets. Financial details were not disclosed.

• Genmab A/S, of Copenhagen, Denmark, said its new HuMax-CD38 was effective in killing primary multiple myeloma tumor cells and a range of tumor cell lines by triggering two immune system-killing mechanisms: antibody-dependent cellular cytotoxicity and complement dependent cytotoxicity.

• Geron Corp., of Menlo Park, Calif., said the May 2005 issue of Fertility and Sterility published studies that show that human embryonic stem cells can be derived without the use of animal cell feeders. The report describes the derivation of new human embryonic stem cell lines that were never exposed to live cells of animal origin. Human placental fibroblasts that were previously shown to be free of pathogens of human, bovine and porcine origin, were used as feeders for the hESC derivations.

• Hana Biosciences Inc., of South San Francisco, initiated a Phase I/II study of talotrexin as a single agent in adult patients with relapsed or refractory acute lymphoblastic leukemia. The Phase I portion will determine the dose, safety, tolerability and pharmacokinetics of talotrexin in refractory leukemia patients, including both myeloid and lymphoid leukemias. The Phase II component will focus on relapsed or refractory ALL patients to determine the efficacy of talotrexin, as measured by complete-response rate.

• Inovio Biomedical Corp., of San Diego, said Whitehouse, N.J.-based Merck & Co. Inc. has exercised an option for a nonexclusive license for an additional antigen to be used with Inovio's MedPulser DNA Delivery System, in development for use with Merck's DNA vaccine research programs. That marks the third antigen selected by Merck under a 2004 license and research collaboration agreement, and calls for Inovio to receive an option fee, as well as potential milestone and royalty payments. A limited number of additional options for further target antigens remain available to Merck, which is responsible for all development and clinical program costs.

• Isotechnika Inc., of Edmonton, Alberta, received permission from the FDA to proceed with a Phase IIb kidney transplant trial for its lead immunosuppressive drug, ISA247. The planned, randomized, open-label trial will include about 332 newly transplanted kidney patients. The primary endpoint of the trial is defined as non-inferiority in biopsy-proven acute rejection episodes with patients receiving ISA247 for six months as compared to tacrolimus. The company previously received a no objection letter from Health Canada on April 28 to begin the Phase IIb kidney transplant trial.

• Laboratory Corp. of America Holdings, of Burlington, N.C., completed its previously reported acquisition of Esoterix Inc., a provider of specialty reference testing, and subsidiaries.

• Medarex Inc., of Princeton, N.J., and Ono Pharmaceutical Co. Ltd., of Osaka, Japan, entered an agreement to research and develop a fully human anti-PD-1 antibody for the potential treatment of cancer. Clinical studies could begin in 12 to 24 months. The companies will share costs and responsibilities up to the completion of a Phase II study. After that, Medarex is responsible for any continued development and commercialization in North America, while Ono is responsible for all areas outside of North America.

• Mera Pharmaceuticals Inc., of Kailua-Kona, Hawaii, entered a collaboration with San Diego-based Rincon Pharmaceuticals Inc., which produces protein therapeutics using microalgae, to use Mera's Growth Modules technology to demonstrate the scalability and economic advantages of using microalgae as a protein-expression system. The agreement calls for Mera to perform pilot studies for Rincon at its Hawaii research and production facility over the next several months. If the first round of studies is successful, Rincon would expect to exercise an option to use the technology to develop its own production capability.

• PR Pharmaceuticals Inc., of Fort Collins, Colo., said the FDA has granted orphan drug status for its lead compound, 2-methoxyestradiol (2ME or PulmoLAR), for the treatment of pulmonary arterial hypertension. The company said the designation was awarded after the agency reviewed data from preclinical and in vitro studies that demonstrated the effects of PulmoLAR in addressing many of the pathological processes associated with PAH.

• Pro-Pharmaceuticals Inc., of Newton, Mass., said the FDA has approved a request for a "compassionate use" investigational new drug for the use of Davanat/5-FU with a patient who has cholangiocarcinoma with liver metastases. Davanat is a polysaccharide in a Carbosome formation that enables the targeted delivery of chemotherapy drugs to protein receptors that are unique to cancer cells.

• ProtoKinetix Inc., of Vancouver, British Columbia, said it has been informed that the University of Rouen's laboratory has completed the engineering of the dimeric class of the synthetic AFGP molecule, which is constructed to provide two active sites. Native AFGP has been proved to be a source of cellular and tissue antifreeze and tests have shown it to be an effective agent in the preservation of sensitive human cells.

• Saegis Pharmaceuticals Inc., of Half Moon Bay, Calif., said the Stanley Medical Research Institute (SMRI) is providing the company with up to $3.8 million to fund clinical trials of SGS518. Saegis is developing the product as a treatment for the cognitive deficit that occurs in schizophrenia. The company previously had received a $2 million investment from the SMRI to support the start of the Phase I study of SGS518, which demonstrated the compound is safe and well tolerated.

• Santarus Inc., of San Diego, filed a shelf registration statement that will permit the company to offer and sell up to $75 million in debt or equity securities. The company plans to use the proceeds to support sales and marketing activities for Zegerid powder for oral suspension and capsules and chewable tablets to treat heartburn and other symptoms of gastrointestinal diseases and disorders. It also will fund research and development activities and other working capital and general corporate purposes.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., reported positive top-line results of its Phase II trial of Puricase in patients with symptomatic gout who do not respond or cannot tolerate conventional therapy. Forty-one patients were randomized to receive Puricase as an intravenous infusion administered once every two weeks (4 mg or 8 mg), or once every four weeks (8 mg or 12 mg), for a three-month treatment period. All dose groups maintained mean plasma uric acid levels below the prospectively planned success criterion of 6 mg/dL.

• Senesco Technologies Inc., of New Brunswick, N.J., added two preclinical human health research programs to further characterize the role of its technologies. The goal of the studies is to add more data to the company's research in the areas of cancer and inflammatory disease. The company will fund an in vitro bladder cancer study at the University of Virginia that will collect data by up-regulating the company's Factor 5a gene in a human bladder cancer cell line. Another research agreement will begin at the University of Pittsburgh, in which the company's technology will be used in an inflammatory bowel disease model in mice.

• Serenex Inc., of Durham, N.C., selected a series of heat-shock protein 90 (Hsp90) inhibitors for advanced preclinical studies, based on their demonstrated efficacy in multiple mouse xenograft tumor studies. The company expects to choose a development candidate from its lead series before the end of the year and initiate clinical studies in 2006. Hsp90 is part of the chaperone complex believed to play a role in cancer.

• Structural Genomix Inc., of San Diego, said the FDA granted orphan drug designation for the company's lead product candidate, Troxatyl (troxacitabine), to treat acute myelogenous leukemia. Troxatyl is a nucleoside analogue that is being studied in a Phase I/II trial to treat relapsed AML and in a Phase I/II trial to treat various solid tumors. The company plans to move the product into a Phase II trial in relapsed and/or refractory adult AML patients in mid-2005.