• Ambion Inc., of Austin, Texas, and Cenix BioScience GmbH, of Dresden, Germany, launched an RNA interference library targeting the Drosophila genome. It consists of more than 13,000 double-stranded RNA molecules for experimental use without further synthesis or purification steps.

• Bristol-Myers Squibb Co., of New York, said it would pay $300 million to settle pending securities litigation against the company and a number of its current and former officers. The suit relates to the company's investment in and relationship with ImClone Systems Inc., also of New York, and ImClone's Erbitux product. As part of the settlement, the company made no admission of wrongdoing. It does not resolve pending governmental investigations and other private litigation related to wholesaler inventory issues and other accounting matters.

• Ciphergen Biosystems Inc., of Fremont, Calif., said findings published in the June 28, 2004, issue of the Journal of the American Medical Association detailed biomarkers discovered using its SELDI ProteinChip technology. Data showed promising results in the early diagnosis of intra-amniotic infection, a major cause of preterm birth, and that the biomarkers could be detected in serum, suggesting possible development of a noninvasive diagnostic test.

The Cleveland Clinic Lerner Research Institute in Cleveland said researchers in its neuroscience department published findings on the Nature Medicine website showing that Nogo, a protein known for its ability to regulate nerve regeneration, might control the progression of Alzheimer's disease. Also called reticulon, the molecule interacts with BACE1 to decrease beta-amyloid production. The findings also will run in next month's issue.

• Conforma Therapeutics Corp., of San Diego, began two Phase I trials of CNF1010, a small-molecule inhibitor of heat-shock protein 90. One trial is enrolling cancer patients with advanced solid tumors, while the other is being conducted in chronic myelogenous leukemia patients. CNF1010 contains a new form of the geldanamycin derivative 17-AAG. The open-label, non-randomized, dose-finding trials are designed to evaluate the product's safety, tolerability, pharmacokinetic and pharmacodynamic profile. Conforma is conducting the studies at multiple U.S. sites.

• Cytorex Biosciences Inc., of Weston, Fla., said data to be presented at the Drug Discovery Conference in Boston would describe the effect of Cytoreg on biomarkers in B16-F10 murine melanoma. The therapeutic agent induced some down-regulation in Bax, and biomarker levels of Survivin and the (P) Raf-1/Raf-1 ratios were decreased in the Cytoreg-treatment group.

• CV Therapeutics Inc., of Palo Alto, Calif., began a study of Ranexa, which, if successful, could support its approval in chronic angina in a restricted patient population. The study is being conducted under the FDA's special protocol assessment process, along with another trial that could result in approval as first-line therapy for chronic angina, as well as for the treatment and long-term prevention of acute coronary syndromes. Plans for the first trial were reported two months ago, while the newest study was outlined in the past week. (See BioWorld Today, June 4, 2004, and Aug. 2, 2004.)

The Institute for Therapeutic Discovery in Albany, N.Y., said it would expand its research of diabetes and diabetic neuropathy using a low-level antibody therapy. The not-for-profit organization said preclinical results showed that such a treatment might reverse the disease, possibly eliminating the need for insulin. It plans to open a laboratory in Providence, R.I., to focus on the agent's mechanism of action.

• Eisai Inc., of Teaneck, N.J., launched a new sales force focused on promoting pharmaceutical products to treat central nervous system disorders, more than doubling its total field force. The sales team will be responsible primarily for promoting Aricept (donepezil hydrochloride tablets) for mild to moderate Alzheimer's disease, and also supporting the neurology sales force in its promotion of Zonegran (zonisamide capsules) for the adjunctive treatment of partial seizures in adults with epilepsy. The company is a subsidiary of Eisai Co. Ltd., of Tokyo.

• Epimmune Inc., of San Diego, said data published in the Aug. 1, 2004, issue of the Journal of Immunology showed that an epitope-based HIV-1 vaccine can be designed to induce cytotoxic T lymphocytes (CTL) capable of recognizing viruses from different parts of the world. HLA transgenic mice were used to show that CTL produced as a result of immunization with an epitope-based DNA vaccine can recognize naturally occurring, variant forms of epitopes that are commonly found in, and, even representative of, different subtypes. The recognition patterns of variant epitopes by CTL were predictable, with about 80 percent accuracy.

• Gamida-Cell Ltd., of Jerusalem, completed enrollment in its Phase I/II trial of StemEx for leukemia. The company expects initial results within the next six months. It also said preclinical data published in this month's issue of Cytotherapy describe the research underlying StemEx, a unit of an expanded population of stem cells derived from cord blood.

• Genetronics Biomedical Corp., of San Diego, said findings reported at the Gordon Research Conference on Bioelectrochemistry in New London, Conn., showed an electroporation-mediated method for delivering DNA in humans without anesthesia was safe and tolerable. The company noted that the results, which measured pain response in healthy volunteers with an electrical pulse suitable for DNA delivery using its MedPulser DNA Delivery System, support electroporation as a potential DNA delivery method for use in humans. On Monday, Genetronics' stock (AMEX:GEB) fell 18 cents, or 14.4 percent, to close at $1.07.

• IGI Inc., of Buena, N.J., gained an exclusive license from the University of Massachusetts Medical School for the school's U.S. Patent No. 6,645,513, B2 titled "The Treatment of Skin with Adenosine or Adenosine Analogs." IGI intends to encapsulate adenosine or adenosine analogues in its Novasome nanosphere transdermal delivery technology for use in the skin-care field.

• Imcor Pharmaceutical Co., of San Diego, named Brian Gallagher chairman. He previously served as chairman, president and CEO of CollaGenex Pharmaceuticals Inc., of Newtown, Pa. The specialty pharmaceutical company, formerly called Photogen Technologies Inc., also appointed Darlene Deptula-Hicks to its board.

• Immucor Inc., of Norcross, Ga., said its board authorized the company to repurchase up to an additional 500,000 common shares. Immucor, which provides automated instrument-reagent systems to the blood transfusion industry, instituted a repurchase program in June for up to 300,000 shares.

• Innate Pharma SAS, of Marseille, France, raised €15 million in a third round of financing. The company said the funds would be used to continue its clinical development programs and begin developing newly identified molecules. Innate, which approaches drug development based on the pharmacology of non-conventional lymphocyte populations such as natural-killer and gamma-delta T cells, has raised more than €40 million since its creation in 1999. The latest financing included new investors Novo Nordisk A/S, Quilvest and NIF Ventures, as well as existing investors Sofinnova Partners, Alta Partners, GIMV, Auriga Partners, Axa Private Equity, Gilde Biotech & Nutrition and Innoveris.

• ISTA Pharmaceuticals Inc., of Irvine, Calif., submitted a supplemental new drug application to the FDA seeking approval for a single-use, 150 USP units/mL vial of Vitrase (hyaluronidase for injection; lyophilized, ovine) for use as a spreading agent. The company said the new vial size would be optimal for spreading agent use. Three months ago, the FDA approved Vitrase in a 6,200 USP units multi-purpose vial. (See BioWorld Today, May 7, 2004.)

• Metaphore Pharmaceuticals Inc., of Fort Lee, N.J., said data published in the Journal of Pharmacology and Experimental Therapeutics detailed findings from studies involving its lead drug candidate, M40403, a superoxide dismutase mimetic. The studies showed superoxide to be a mediator of pain and suggested that M40403 represents a new nonnarcotic option for pain management.

• NitroMed Inc., of Lexington, Mass., said it is accelerating its expected timeline for the commercialization of BiDil, its lead product in development for the treatment of heart failure in African-Americans. To that end, the company appointed Mark Pavao its senior vice president of sales and marketing. He previously was with Bristol-Myers Squibb Co., of New York, where he was vice president of neuroscience marketing. Last month, NitroMed prematurely halted its confirmatory Phase III trial of BiDil because of a significant survival benefit seen in patients treated with the drug. It expects to launch the product next year, assuming FDA approval. On Monday, NitroMed's stock (NASDAQ:NTMD) gained $4.82, or 27.6 percent, to close at $22.30. (See BioWorld Today, July 20, 2004.)

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., completed patient enrollment in its Phase I trial evaluating Cotara for colorectal cancer. The study was designed to determine the maximum tolerated dose and safety profile of intravenously administered Cotara, an iodine-131 radiolabeled tumor necrosis therapy monoclonal antibody that might be used for the treatment and diagnosis of various solid-tumor cancers. Interim data are being analyzed, as follow-up data on treated patients continues to be collected.

The Pittsburgh Life Sciences Greenhouse in Pittsburgh said Revivicor Inc. leased laboratory space in its incubator facility. The company is commercializing regenerative medicine therapies for the replacement of cells, tissues and organs. Recently spun out of PPL Therapeutics plc, of Edinburgh, Scotland, Revivicor is focused on treatments for diabetes and whole-organ transplantation developed from xenografts, stem cells and tolerance technologies.

• Point Therapeutics Inc., of Boston, said preclinical data published in the August 2004 issue of Cancer Research showed that its lead product candidate, talabostat (PT-100), slowed growth or caused regression and rejection of certain experimental tumors in mice in vivo. Findings demonstrated that the antitumor effect of talabostat appears to involve tumor-specific cytotoxic T lymphocytes (CTL) and protective immunological memory. Increased mRNA expression of cytokines and chemokines known to promote T-cell and other innate effector cell activity also was observed. On Monday, the company's stock (NASDAQ:POTP) gained 47 cents, or 12.1 percent, to close at $4.35.

• Qiagen NV, of Venlo, the Netherlands, entered a global supply agreement with Novartis Pharma AG, of Basel, Switzerland. Qiagen will be its global supplier for consumable products for nucleic acid stabilization, separation, purification, handling and amplification, as well as automated instrumentation, siRNA products and related services. Financial terms were not disclosed.

• Schering-Plough Corp., of Kenilworth, N.J., said the Committee for Medicinal Products for Human Use of the European Agency for the Evaluation of Medicinal Products recommended approving expanded labeling for Remicade (infliximab), in combination with methotrexate, for active and progressive psoriatic arthritis in patients who have responded inadequately to disease-modifying antirheumatic drugs. The positive opinion primarily is based on data from a study called IMPACT (Infliximab Multinational Psoriatic Arthritis Controlled Trial). Remicade also is marketed by Centocor Inc., of Malvern, Pa.

• Serenex Inc., of Durham, N.C., raised $8 million in an extension of its Series B private placement of preferred stock. The company plans to use the funding to advance its discovery programs in oncology and inflammation. Intersouth Partners led the round, which also included Takeda Research Investment and Western Technology Investment. Existing investors included Mediphase Venture Partners, Lilly BioVentures and Seaflower Ventures.

• TolerRx Inc., of Cambridge, Mass., began a Phase I trial of TRX4 in subjects with psoriasis. The single-dose, dose-escalation study is designed to establish the monoclonal antibody's safety, pharmacokinetic and pharmacodynamic profile. About 30 moderate to severe psoriasis subjects will be enrolled.

• Valeant Pharmaceuticals Inc., of Costa Mesa, Calif., sold its raw materials and manufacturing operations in the Czech Republic to Chemoprojekt a.s., of Prague. The operations previously were reported as discontinued operations by Valeant. Terms were not disclosed.

• VaxGen Inc., of Brisbane, Calif., named Randall Caudill chairman. He served as a company director for six years and is the president of a financial consulting firm called Dunsford Hill Capital Partners, of San Francisco. At the same time, VaxGen also named CEO Lance Gordon president, while William Young resigned as a director.

• Vital Therapies Inc., of San Diego, said the FDA granted orphan drug designation for the use of immortalized human liver cells to treat acute liver failure. The cells are the biologic component of the company's ELAD (Extracorporeal Liver Assist Device) system, which is in clinical development. Phase I and II trials have been completed on 42 acute liver failure patients, and the results have been submitted to the FDA. Vital Therapies remains in discussions with the agency in preparation for the next trial.

• Zeltia SA, of Madrid, Spain, said its Neuropharma subsidiary raised €16 million via a private placement with institutional and retail investors. The funds will finance projects over the next 18 months to 24 months at Neuropharma, which specializes in the research and development of therapeutics against Alzheimer's and other central nervous system diseases, and allow it to advance one or two compounds into Phase I trials. The transaction implied a pre-money valuation of €45 million for the company. Banco Banif structured the placement and advised Zeltia on the transaction.

No Comments