• Alexion Pharmaceuticals Inc., of Cheshire, Conn., said results from a Phase III study called SHEPHERD with Soliris (eculizumab) showed that the therapy reduced hemolysis and improved fatigue, overall quality of life and anemia in a diverse population of patients with a rare blood disorder called paroxysmal nocturnal hemoglobinuria (PNH), according to an analysis of the trial published online in Blood. Soliris was approved in March by the FDA for PNH.

• Celtic Pharmaceutical Holdings LP, of New York, disclosed interim results of an on-going, open-label extension trial evaluating the long-term safety and efficacy of Xerecept as a potential treatment for peritumoral brain edema, or tumor-related brain swelling. The data presented in a poster presentation at the Society for Neuro-Oncology annual meeting in Dallas demonstrated that 20 of the first 32 patients enrolled received the drug daily for at least 20 weeks and it was well-tolerated. Nine of the 20 patients discontinued dexamethasone altogether, and steroid side effects were resolved or improved in the majority of patients who received a reduced dexamethasone dose.

• EntreMed Inc., of Rockville, Md., started a Phase II trial of MKC-1 in patients with advanced pancreatic cancer. The primary objectives will be to determine the antitumor activity of the orally administered drug in unresectable or metastatic pancreatic cancer patients who have failed at least one prior chemotherapy regimen. The study also will assess safety, tolerability and overall median survival time. MKC-1 is a cell-cycle inhibitor that has shown antitumor activity as both a single agent and in combination with an approved epidermal growth factor/epidermal growth factor receptor inhibitor in pancreatic cancer models. The drug also is in trials in metastatic breast cancer, non-small-cell lung cancer and leukemia.

• Karo Bio AB, of Stockholm, Sweden, entered Phase I development with its diabetes drug, KB3305, which will be given in ascending doses to healthy volunteers as well as to Type II diabetes patients. The entire Phase I program will include about 110 subjects. KB3305 is a liver-targeted glucocorticoid antagonist designed to suppress hepatic glucose production, resulting in decreased fasting blood glucose levels.

• Medarex Inc., of Princeton, N.J., said the FDA allowed two separate investigational new drug applications filed MDX-1342, one for the treatment of chronic lymphocytic leukemia and the other for rheumatoid arthritis. MDX-1342 is a fully human antibody that targets CD19, a molecule specifically expressed on normal B-cells and malignant B-cells in diseases such as CLL, acute lymphoblastic leukemia, follicular non-Hodgkins lymphoma, diffuse large B-cell lymphoma and mantle cell lymphoma. The company plans Phase I trials in both indications.

• Myriad Genetics Inc., of Salt Lake City, submitted an investigational new drug application to the FDA to begin trials with Vivecon (MPC-9055), for the treatment of AIDS. Vivecon is a novel, small-molecule drug candidate that Myriad has designed to be taken orally and to inhibit viral maturation. The compound inhibited viral particles from reaching maturity, so they were incapable of infecting other cells, by targeting the capsid-SP1 cleavage site in the HIV Gag protein.

• Novogen Ltd., of Sydney, Australia, said a recently completed Phase Ib clinical trial of a new drug to treat inflammatory bowel disease (IBD) indicates that treatment may be possible with just a single daily dose. The drug, NV-52, is an oral agent for the maintenance of remission in IBD. NV-52 was administered once daily over seven days to nine healthy volunteers. Follow-up showed that concentrations of NV-52 were maintained in the plasma of the volunteers at the level associated with suppression of colitis in the mouse model of IBD, suggesting only once-daily dosing would be required in IBD patients.

• PhytoMedical Technologies Inc., of Princeton, N.J., disclosed plans to start a dose-escalation study with the company's compounds for Type II diabetes, after successful completion of earlier studies of the same compounds. evaluating their viability and important diabetes-related activity.

• Portola Pharmaceuticals Inc., of South San Francisco, has begun a Phase II clinical trial of the intravenous formulation of PRT060128 in patients experiencing an ST-segment elevation myocardial infarction. The trial, known as ERASE-MI, will enroll approximately 200 patients across North America and Europe. PRT060128 is an antiplatelet compound that is the only reversible I.V. and oral ADP receptor antagonist in clinical development.

• Sangamo BioSciences Inc., of Richmond, Calif., completed enrollment of its Phase II trial of SB-509, a ZFP Therapeutic for mild to moderate diabetic neuropathy. Data are expected in the second half of 2008. The trial has been partially funded by a $3 million commitment from the Juvenile Diabetes Research Foundation International as part of a research agreement with Sangamo, and completion of enrollment triggers a milestone payment under that agreement.

• Serenex Inc., of Durham, N.C., has begun a second Phase I trial in hematological malignancies, for SNX-5422, its novel heat shock protein 90 (Hsp90) inhibitor. SNX-5422 is a totally synthetic small molecule delivered orally and was discovered internally using Serenex's proprietary chemoproteomics technology platform. The study will be a dose-escalation trial involving up to 50 patients with hematological malignancies. The trial will evaluate safety, pharmacokinetic and pharmacodynamic properties of SNX-5422 and will be conducted at Vanderbilt University and the University of Pittsburgh Cancer Institute.

• Stem Cell Therapeutics Corp., of Calgary, Alberta, has received a "no objection" letter from Health Canada for the REGENESIS trial, a Phase II prospective, randomized, double-blind, placebo controlled study of NTx-265, a human chorionic gonadotropin and epoetin alfa in acute ischemic stroke patients investigating efficacy and safety endpoints. The goal is to have full enrollment of 120 patients completed before the end of 2008.

• ThromboGenics NV, of Brussels, Belgium, said its Phase II trial with microplasmin showed positive clinical results in patients with vitreomacular traction, a cause of back-of-the-eye disease. The study, giving patients 75 mcg or 125 mcg of drug, also showed that microplasmin therapy was safe and well tolerated, and the company recruited 15 more patients to evaluate a higher, 175 mcg dose. ThromboGenics presented the results of the trial at the American Society of Retina Specialists' annual meeting.

• Vion Pharmaceuticals Inc., of New Haven, Conn., has started an investigator-sponsored Phase I clinical trial of its lead anticancer agent Cloretazine (VNP40101M) in combination with hematopoietic cell transplant (HCT) in patients with various advanced hematologic malignancies. The objective is to define the maximum-tolerated dose when given to patients with poor-prognosis leukemia, lymphoma and Hodgkin's disease who are undergoing either an allogeneic or autologous HCT.