• AndroScience Corp., of San Diego, successfully completed an investigational new application filing and intends to begin a Phase I trial this quarter of the acne product ASC-J9, a topical anti-androgen agent. AndroScience also has drug candidates in preclinical testing for alopecia, prostate cancer, benign prostate hyperplasia and other androgen-related disorders.

• BioLineRx Ltd., of Jerusalem, successfully completed Phase I trials of its lead product, BL-1020, a GABA-enhanced antipsychotic for schizophrenia. Results from the trial showed that the drug was well tolerated and demonstrated an improved safety profile, which included reducing the extrapyramidal symptoms associated with available therapies. The studies, which involved a total of 48 volunteers, showed no adverse drug-related effects on ECG parameters, clinical lab data and neurological assessments. BioLineRx anticipates starting Phase II studies later this year.

• Ciphergen Biosystems Inc., of Fremont, Calif., initiated a trial to evaluate its ovarian cancer triage test to differentiate women with ovarian cancer from women with benign pelvic masses. The study seeks to demonstrate that the positive predictive value of the test is better than the existing standard of care, defined as physical and radiological exam. Ciphergen plans to enroll between 700 and 1,000 patients, depending on the prevalence of cancer within the study population. Results from the trial will be submitted to the FDA for clearance of the test as an in vitro diagnostic.

• Dynogen Pharmaceuticals Inc., of Waltham, Mass., reported positive results from its Phase II trial of DDP733 in patients with irritable bowel syndrome with constipation, in which the drug achieved a statistically significant overall clinical response rate of 54 percent in those receiving 1.4 mg t.i.d compared to 15 percent for the placebo group. The 91-patient study was designed to assess clinical response using the Overall Subject Global Assessment of IBS relief in patients receiving DDP733, an oral partial agonist of the serotonin Type 3 receptor (5-HT3). Dynogen also is investigating the compound in a Phase Ib trial in nocturnal gastroesophageal reflux disease.

• Euralstem Inc., of Rockville, Md., reported that a study using its human neural stem cells was published in PLoS medicine. Researchers from Johns Hopkins Medical Institutions transplanted the stem cells into rats with spinal cord damage. The cells turned into neurons and made extensive synaptic contact with damaged host motor neurons.

• Illumina Inc., of San Diego, said that researchers using the Infinium HumanHap300 and Human-1 BeadChips uncovered four important gene variations that increase the risk of developing Type-2 diabetes. The genes, which were reported in the journal Nature, could explain up to 70 percent of the genetic background of Type-2 diabetes.

• InSite Vision Inc., of Alameda, Calif., said top-line results from its Phase I study of AzaSite Plus (ISV-502), a combination antibiotic/corticosteroid product formulated in DuraSite, showed that the product was well tolerated, with no serious adverse events reported. The study enrolled 46 subjects to receive eye drops of either AzaSite Plus or placebo two times daily for 14 days.

• Neurochem Inc., of Laval, Quebec, said it received a second recommendation from the European data safety monitoring board to continue its ongoing Phase III trial of tramiprosate (Alzhemed) in Alzheimer's disease. It followed an interim analysis of available safety data from 491 patients who have been on study medication for an average of 3.6 months. The company recently completed its 1,052-patient North American Phase III trial.

• Northwest Biotherapeutics Inc., of Bothell, Wash., said the first two patients in its pivotal Phase II trial have undergone surgery for newly diagnosed glioblastoma multiforme, which is the first step in preparation of the company's DCVax-Brain treatment. The treatment consists of three initial immunizations at two week intervals, followed by booster injections at two- and four-month intervals for the remainder of one year. After that, patients are to receive semiannual maintenance injections for an additional two years. DCVax-Brain uses a patient's own tumor, surgically removed, to prepare a mix of their personal cancer biomarkers, which are loaded into the patient's dendritic cells and injected back into the patient through an intradermal injection. The company expects to complete patient enrollment in the fourth quarter.

• Osiris Therapeutics Inc., of Baltimore, said six-month interim results from a Phase I/II study evaluating the safety and effectiveness of Chondrogen, a preparation of adult stem cells formulated for direct injection into the knee, in the regeneration of the meniscus in the knee. Data from the 55-patient trial showed that Chondrogen met its primary endpoint of demonstrating safety, but did not show a statistically significant increase in the volume of meniscus as compared to placebo. The company, however, reported that an improvement in baseline cartilage and joint condition was noted in about 30 percent of patients treated with the stem cell drug compared to zero patients in the placebo group. Results were presented at the Stem Cell Summit in San Diego.

• Poniard Pharmaceuticals Inc., of South San Francisco, filed an investigational new drug application to begin a Phase I trial of an oral formulation of picoplatin, a platinum therapy designed to overcome and prevent platinum resistance associated with chemotherapy in solid tumors. An intravenous version of the drug is in an ongoing Phase II trial in small-cell lung cancer and in Phase I/II trials in colorectal and hormone-refractory prostate cancer. A pivotal Phase III program is expected to begin in SCLC in the first half of this year.

• Rigel Pharmaceuticals Inc., of South San Francisco, said its partner, Geneva-based Merck Serono started enrolling patients in a Phase I study of R763, an oral, multi-Aurora kinase inhibitor aimed at treating hematological malignancies. It is the second of several Phase I trials expected to be conducted with R763 in different types of cancer. Merck Serono licensed development and commercialization rights to R763 and Rigel's Aurora kinase program in October 2005. (See BioWorld Today, Oct. 26, 2005.)

• Sangart Inc., of San Diego, began enrolling patients in two parallel European Phase III trials of Hemospan, an oxygen therapeutic specifically engineered to target oxygen delivery to tissues. More than 800 elective orthopedic surgery patients will be enrolled in the studies, which are designed to gauge the ability of Hemospan to prevent and treat hemodynamic instability, especially low blood pressure (hypotension), during their operations. The product is designed to be an alternative to blood transfusions.

• SIGA Technologies Inc., of New York, launched a multiple-dose Phase I trial of SIGA-246, its lead smallpox drug. The study will examine the safety, tolerability and pharmacokinetics of SIGA-246 at three different dosages in healthy volunteers when taken once a day for 21 days. SIGA said the product is the most advanced smallpox treatment in clinical development.

• Somaxon Pharmaceuticals Inc., of San Diego, said the FDA has agreed that its lead product, Silenor (doxepin HCI) does not appear to have genotoxic potential. The agency indicated that unless other preclinical data raise a concern, a complete assessment of the carcinogenic potential of the drug may not be needed prior to approval of a new drug application. The FDA also indicated it may accept the results of a shorter-term carcinogenicity study for approval of the NDA and allow the standard two-year carcinogenicity study to be completed as a Phase IV trial. The company expects to file an NDA in the third quarter.

• Stem Cell Innovations Inc., of Houston, announced that the company is presenting data on SCI's PluriCell stem cell system at the Stem Cells World Congress in San Diego. The data show the ability of PluriCells to become endothelial cells, which line the arteries and play a role in cardiovascular disease. PluriCells might provide a drug discovery platform as well as a potential cell therapy for use in cardiovascular disorders.

• Transgene SA, of Strasbourg, France, said the first patients have been enrolled in a Phase I trial of its therapeutic vaccine candidate TG4040 (MVA-HCV) for patients chronically infected with the hepatitis C virus. The trial, conducted in France, will enroll 15 patients who have never received any therapy for their condition. The primary endpoint is safety. Secondary endpoints are immunological response to the vaccination and effect on viral load.