• Acacia Research Corp., of Newport Beach, Calif., said its CombiMatrix group entered a nonexclusive distribution agreement with Inter Medical Co. Ltd. to distribute CustomArray microarray products in Japan. The products are based on a customizable DNA microarray. The agreement will expand CombiMatrix's international distribution network.

• Achillion Pharmaceuticals Inc., of New Haven, Conn., received a Phase I Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases covering HIV research in capsid inhibition. The grant will support Achillion's program for identifying small-molecule HIV capsid assembly inhibitors, and to further characterize capsid inhibition as a method of HIV treatment.

• Antigenics Inc., of New York, said the June 2005 issue of Nature Immunology published research that supports the immunological mechanism of action of the company's heat-shock protein-based investigational personalized cancer vaccines, Oncophage and AG-858. The paper demonstrates that complexes of Hsps and peptides are the necessary and sufficient form of antigen to activate a killer-T-cell immune response in vivo. The study adds evidence that HSP-chaperoned peptides play an important role in generating antigen-specific immune responses against cancers and infections.

• Ariad Pharmaceuticals Inc., of Cambridge, Mass., said that the investigational new drug application for the oral dosage form of its mTOR inhibitor, AP23573, was filed with the FDA in late March and now is effective. The company expects to begin enrollment in the first clinical trial with the tablet form of AP23573 later this quarter. The small-molecule drug is designed to starve cancer cells and shrink tumors by inhibiting the cell-signaling protein, mTOR.

• Atom Sciences Inc., of Oak Ridge, Tenn., was awarded a $100,000 Small Business Innovative Research grant from the National Institutes of Health's Institute of Allergy and Infectious Diseases to develop a diagnostic tool for tuberculosis. Atom Sciences said the diagnostic method, called Limited Primer Extension, or LPE, can screen clinical samples for the bacterium that cause human tuberculosis. At the same time, it also can test for related infectious agents that cause tuberculosis-like symptoms.

• Celera Genomics Group, of Rockville, Md., submitted an investigational new drug application with the FDA to start Phase I trials of CRA-024781, a histone deacetylase inhibitor. Celera reported data at the American Association for Cancer Research meeting in April showing the efficacy of CRA-024781 as an HDAC inhibitor in xenograft cancer models. Studies have also shown that the measurement of tubulin and histone acetylation can be used to monitor the pharmacodynamic effects of CRA-024781 in vivo.

• Cortex Pharmaceuticals Inc., of Irvine, Calif., said CX717, when compared to placebo, increased wakefulness in a dose-related manner and improved performance in healthy male subjects that became impaired during 27 hours without sleep. In the study, 16 young healthy men were administered three different doses of CX717 and a placebo control in a randomized, double-blind, four-way crossover design. Cortex plans to conduct pilot studies in brain disorders, such as Alzheimer's disease, attention deficit hyperactivity disorder and sleep disorders.

• Endovasc Inc., of Montgomery, Texas, held a teleconference with the FDA and its contract research organization to discuss Liprostin studies needed to file a new drug application. Endovasc has submitted to the FDA a biostatistical analysis from its Phase II Liprostin study in Europe and Mexico. The company is positioning Liprostin, a prostaglandin E1 hormone stabilized in tiny microspheres, to become the pharmacotherapy to treat the effects of critical limb ischemia.

• Exelixis Inc., of South San Francisco, submitted an investigational new drug application with the FDA to begin a Phase I trial of XL844, an inhibitor of the checkpoint kinase pathway. The product has demonstrated significant potency in biochemical and cellular assays, oral bioavailability and an attractive pharmacokinetic profile. While it has potential as a single agent, XL844 also has increased the effectiveness of other cancer drugs in animal models.

• Genaera Corp., of Plymouth Meeting, Pa., announced positive interim trial results from a multicenter open-label U.S. Phase II trial of Evizon (squalamine lactate) to treat choroidal neovascularization associated with age-related macular degeneration. The data were presented Sunday at the Association for Research in Vision and Ophthalmology annual meeting. In 18 subjects who received 10-, 20- or 40-mg doses, Evizon was shown to be well tolerated and there were no drug-related systemic, ocular or serious adverse events.

• Genzyme Corp., of Cambridge, Mass., entered a license agreement with the Massachusetts General Hospital and Dana-Farber Cancer Institute to obtain exclusive, worldwide diagnostic rights to their discovery of gene mutations recently found in some patients with non-small-cell lung cancer. The presence of the mutations correlates with clinical response to certain drugs used in treating non-small-cell lung cancer. Genzyme plans to develop and market a diagnostic test for the epidermal growth factor receptor markers that can help identify patients who are most likely to respond to targeted cancer therapies.

• Halozyme Therapeutics Inc., of San Diego, said preclinical studies with recombinant human PH20 (rHuPH20) hyaluronidase enzyme were presented at the 2005 Association for Research in Vision and Ophthalmology annual meeting in Fort Lauderdale, Fla. Data showed that when viscoelastic agents commonly used in cataract surgery were left in the eyes of animals, injection of rHuPH20 enzyme into the front of the eye significantly reduced the incidence and severity of intraocular pressure rises. The study also showed that injection of rHuPH20 caused no toxicity to the corneal endothelial cells in the eye.

• Helix BioPharma Corp., of Aurora, Ontario, selected a lead product candidate, L-DOS47, derived from the company's DOS47 cancer therapeutic program. The candidate combines the therapeutic with a specific antibody developed by the Institute for Biological Sciences of the National Research Council of Canada to form a treatment for adenocarcinoma of the lung. The company entered a worldwide exclusive license with NRC-IBS to develop L-DOS47 as a potential human therapeutic. The license calls for an up-front fee and certain milestone payments at clinical stages. Helix also has rights to use the antibody to develop future DOS47-related products.

• Immunomedics Inc., of Morris Plains, N.J., closed a private placement of its 5 percent senior convertible notes due 2008 and common stock warrants with qualified institutional buyers and institutional accredited investors, raising $37.7 million. Lazard Freres & Co. LLC served as lead placement agent with C.E. Unterberg, Towbin as co-placement agent. The proceeds will fund two pivotal trials of epratuzumab in lupus patients, which are scheduled to begin in the first half of this year. Purchasers have an option to buy up to an additional 20 percent in notes and warrants, which could result in another $7.5 million in gross proceeds.

• Large Scale Biology Corp., of Vacaville, Calif., filed an application to gain orphan drug designation for its lysosomal acid lipase (LAL) therapeutic enzyme. LAL is a naturally occurring human enzyme involved in the metabolism of certain lipids, including cholesteryl esters and triglycerides. Last week, the company entered a research and development agreement with Bayer CropScience, of Research Triangle Park, N.C., to explore LAL for selected medical indications.

• MacroPore Biosurgery Inc., of San Diego, signed a definitive agreement to raise $11 million from the sale of 1.1 million shares at $10 each. The investor has been granted an option to purchase an additional 2.2 million shares at $10 each by Dec. 31, 2006, and the investor received an offer of a voting seat on the company's board. MacroPore will use the funds to support research and development of its regenerative cell technology.

• Metabolex Inc., of Hayward, Calif., extended its multiyear research collaboration with Tokyo-based Astellas Pharma Inc. (formerly Yamanouchi Pharmaceutical Co. Ltd.) to validate drug targets with the goal of advancing candidates into development for Type II diabetes and obesity. Under the one-year extension, Metabolex will receive research funding and screening and development milestones from Astellas. The companies initiated the research collaboration in late March 2002. Metabolex retains co-promotion rights in North and South America and could receive royalties on sales of any products that emerge.

• Metaphore Pharmaceuticals Inc., of Fort Lee, N.J., started a randomized, double-blind, placebo-controlled study to evaluate M40403 when administered with morphine for post-surgical pain. The study is expected to enroll 240 subjects who have undergone a bunionectomy at centers in Texas and Utah. It will compare the analgesic efficacy of a single intravenous dose of M40403 at one of two dose levels administered with morphine vs. the analgesic efficacy of morphine alone.

• Myogen Inc., of Denver, said it received orphan drug designation in Europe for ambrisentan to treat pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension. Last August, the FDA granted orphan drug designation to ambrisentan to treat PAH. The company is studying the product, a Type-A selective endothelin receptor antagonist, to treat PAH in two pivotal Phase III trials.

• Neurobiological Technologies Inc., of Richmond, Calif., received a royalty payment of about $1.1 million from Merz Pharmaceuticals GmbH, of Frankfurt, Germany, for sales of Memantine for the treatment of moderate to severe Alzheimer's disease in the quarter ended March 31.

• Neurologix Inc., of Fort Lee, N.J., entered an agreement with Medtronic Inc., of Minneapolis, for the joint development, manufacturing and commercialization of micro-infusion catheters designed to deliver gene therapy into the brain and central nervous system. The companies will jointly develop, and Medtronic will manufacture delivery devices for Neurologix's Parkinson's disease and temporal lobe epilepsy clinical programs, and they will have a revenue-sharing arrangement upon the commercialization of the device. Medtronic increased its equity investment in Neurologix by $2 million, purchasing about 1.1 million shares at $1.75 per share, plus warrants to purchase 285,388 shares at $2.19 per share.

• Neurotech SA, of Paris, reported positive results from an open-label Phase I trial of its lead product, NT-501, at the 77th annual meeting of the Association for Research in Vision and Ophthalmology conference in Fort Lauderdale, Fla. NT-501 uses Neurotech's encapsulated cell technology as a device to deliver ciliary neurotrophic factor (CNTF) to eyes of visually impaired patients with retinitis pigmentosa. Results confirm that CNTF can be safely delivered into the vitreous of patients with RP and that the ECT device was well tolerated by patients.

• Ortec International Inc., of New York, said that after submitting clinical data that demonstrated clinical significance in both the intent-to-treat population as well as those patients with ulcers for whom the use of OrCel is indicated, the FDA recommended that a confirmatory trial, involving only those patients for which OrCel is indicated, is necessary. Ortec estimates that about 40 patients will be required for the study of OrCel in treating venous leg ulcers.

• OSI Pharmaceuticals Inc., of Melville, N.Y., and Genentech Inc., of South San Francisco, submitted a supplemental new drug application to the FDA for Tarceva (erlotinib) plus gemcitabine to treat advanced pancreatic cancer in patients who have not received previous treatment. The filing is based on data from a pivotal Phase III trial that were released in September and presented in January at the 2nd Annual Gastrointestinal Cancers Symposium in Hollywood, Fla. The study demonstrated a statistically significant 23.5 percent improvement in overall survival in patients receiving Tarceva plus gemcitabine compared to patients receiving gemcitabine plus placebo. (See BioWorld Today, Sept. 21, 2004.)

• Pharmacyclics Inc., of Sunnyvale, Calif., said that Cancer Research published a study that further characterizes the mechanism of action of Xcytrin (motexafin gadolinium) Injection and provides better understanding of the drug's anticancer properties. In a series of gene-expression profiling analyses and biochemical studies on human lung, prostate and lymphoma cancer cell cultures treated with Xcytrin, the researchers found that it elicited a specific response that manifested in elevated levels of metallothionein isoforms and zinc transporter 1 transcripts.

• Pharming Group NV, of Leiden, the Netherlands, reported clinical results from Phase II/III studies with recombinant human C1 inhibitor for the treatment of hereditary angioedema. Patients treated with rhC1INH showed a three-minute median time to beginning of relief and a four-hour median time to resolution. Time to beginning of relief was between 15 minutes to two hours, and time to resolution was between one hour and 24 hours in treated patients.

• Protein Polymer Technologies Inc., of San Diego, has applied for a listing on the American Stock Exchange. The company's stock is traded on the OTC Bulletin Board under the symbol "PPTI." Protein Polymer Technologies develops products to improve surgical and medical outcomes and focuses on protein design and synthesis.

• Qiagen NV, of Venlo, the Netherlands, and Epigenomics AG, of Berlin, entered a collaboration to jointly develop and introduce a pre-analytical solution portfolio for DNA methylation analysis. The portfolio is expected to provide validated pre-analytical solutions for use in preclinical research and be compatible to in vitro diagnostics.

• QLT Inc., of Vancouver, British Columbia, said the Toronto Stock Exchange has accepted notice of the company's intention to purchase for cancellation up to 4.7 million shares for a maximum expenditure of $50 million. The actual number of common shares that could be purchased and the timing of any purchases will be determined by QLT. The period allowed for repurchasing begins May 4 and ends May 3, 2006. The company had 93.8 million shares outstanding as of April 28.

• Senomyx Inc., of La Jolla, Calif., expanded and extended a collaborative research phase under its discovery and development agreement with Kraft Foods Global Inc. During the extension period, which runs through July 30, the company will begin working with Kraft Foods on an exclusive basis to discover and develop flavor modifiers in a new product field in the dessert category. Senomyx also will continue to work with Kraft Foods on flavor enhancers on a coexclusive basis in an existing specified food and beverage product field. Financial terms were not disclosed.

• System Biosciences Inc., of Mountain View, Calif., said it is offering the first small-interfering RNA (siRNA) libraries that target the entire human and mouse genomes. Each GeneNet siRNA Library contains more than 100,000 siRNA templates that target 47,400 human or 39,000 mouse transcripts, which the company said will enable researchers to identify genes with the function of regulating, controlling or otherwise affecting specific biological processes.

• Tercica Inc., of South San Francisco, said the FDA accepted for filing and granted review of the company's new drug application for Increlex, its recombinant human insulin-like growth factor-1 (rhIGF-1). The company is seeking approval to market Increlex for the long-term treatment of short stature caused by a severe form of primary IGF-1 deficiency. Based on the priority-review designation, the FDA has six months from the submission date, or until Aug. 31, 2005, to take action on the NDA filing. Tercica submitted the NDA, based upon results of a 71-patient Phase III trial, on Feb. 28. (See BioWorld Today, March 1, 2005.)

• VIRxSYS Corp., of Gaithersburg, Md., reported the completion of the initial protocol-mandated observations in a Phase I trial evaluating the safety and tolerability of its HIV gene therapy, VRX496. The company said all five patients, who previously had failed two active antiretroviral drug therapy regimens, completed the six-month assessment period, and three of those also reached their one-year post-dosing assessment. The VRX496 therapy includes a lentiviral vector plus antisense, and it is designed to block HIV replication in CD4 T cells and repopulate a patient's immune system with genetically engineered cells that can support immunity against HIV and other infections.