¿ Antex Biologics Inc., of Gaithersburg, Md., completed work funded by a U.S. Army Small Business Innovation Research grant on the development of an oral microbead vaccine to protect U.S. troops against bacteria that cause various gastrointestinal diseases including gastritis and severe dysentery. Antex encapsulated inactivated Campylobacter in a microbead formulation, demonstrated release of intact bacteria cells at desired conditions, and conducted animal studies to identify a dosing regimen. The U.S. Army has requested Antex submit an application for a Phase II contract.
¿ AVAX Technologies Inc., of Kansas City, Mo., responded to the FDA¿s request for additional information related to the clinical hold of AVAX¿s clinical trials of M-Vax and O-Vax, autologous cell cancer vaccines. M-Vax and O-Vax are being studied for the treatment of melanoma and ovarian cancer. Also, AVAX scheduled a meeting with the FDA to discuss issues surrounding the current hold and AVAX¿s planned changes to its product and manufacturing processes. (See BioWorld Today, Sept. 24, 2001.)
¿ Carrington Laboratories Inc., of Irving, Texas, said its board of directors renewed and strengthened the company¿s shareholder rights agreement. The amended agreement extends the term of the original rights agreement, and the preferred share purchase rights issued thereunder, to Oct. 15, 2011.
¿ Cerus Corp., of Concord, Calif., and Baxter Healthcare Corp., of Deerfield, Ill., reported preliminary results from the Phase Ic trial of their Intercept Red Blood Cell System, a pathogen inactivation system being developed to protect against transmission of infectious diseases through red blood cell transfusions. The two-part Phase Ic trial included 40 individuals, 29 of whom participated in a study to evaluate the performance of Intercept red blood cells compared to untreated red blood cells. Preliminary results showed that the mean survival of Intercept red blood cells following infusion was 62.2 days, which did not show statistical difference from the 61.1 days of survival of untreated red blood cells. In addition, the two groups showed comparable mean recovery, with 79.4 percent of Intercept red blood cells surviving 24 hours after infusion compared to 84.7 percent in the untreated group. The remaining 11 individuals participated in a study to evaluate the tolerability of full transfusions of Intercept red blood cells. Intercept red blood cells were well tolerated with no serious adverse events observed. The companies are seeking U.S. and European approval of the Intercept Platelet System, and are conducting a Phase III clinical trial of the Intercept Plasma System.
¿ Cortex Pharmaceuticals Inc., of Irvine, Calif., was notified that the National Institutes of Mental Health will fund the company¿s grant application, ¿Therapeutic Potential of AMPAKINEs in Schizophrenia.¿¿ The Phase II Small Business Innovative Research grant will provide total funding of $769,818. This award will support a Phase IIb study of CX516 as a combination therapy in schizophrenia patients concomitantly treated with olanzapine.
¿ Cyternex Inc., of San Diego, completed a series A private round of financing, raising a total of $3.55 million for the company. The round includes four investor groups, Sanderling Ventures, Novartis BioVentures, RCT BioVentures West and Inglewood Ventures. Cyternex develops small-molecule anticancer agents for patients with advanced disease.
¿ Delcath Systems Inc., of Stamford, Conn., said the National Cancer Institute, of Bethesda, Md., is treating patients with escalating doses of a powerful anticancer agent delivered directly to the liver through Delcath¿s patented drug delivery system. The trial, using melphalan, is intended to provide the data to support a pivotal human trial with the same drug. Delcath designed the system to achieve vascular isolation of the organs with catheters to avoid the need for surgery.
¿ EDEN Bioscience Corp., of Bothell, Wash., reduced its workforce by 18 employees in certain research, administrative and senior leadership positions. In total, the company has reduced its headcount from 138 at the end of the second quarter to 106. EDEN expects these work force reductions to decrease salaries and related expenses by approximately $2.9 million on an annualized basis. EDEN also expects to take a severance charge of up to approximately $300,000 in the fourth quarter of 2001.
¿ Human Genome Sciences Inc., of Rockville, Md., broke ground for a new facility designed to produce the company¿s drug candidates on a commercial scale. Completion of the facility, located in Rockville, is targeted for mid-2003. It will be capable of producing several different types of drugs, including novel human hormones and proteins, and is located immediately adjacent to the company¿s existing smaller-scale manufacturing and quality assurance facilities on the Belward Research Campus of John Hopkins University.
¿ Integra LifeSciences Holdings Corp., of Plainsboro, N.J., said the U.S. District Court for the Southern District of California entered orders in favor of the plaintiffs and against Merck KGaA, of Darmstadt, Germany, on the final post-judgment motions in the case of Integra LifeSciences I Ltd. and The Burnham Institute v. Merck KGaA. The court denied Merck¿s motions for judgment as a matter of law and for a new trial, in each case regarding infringement, invalidity and damages. The court¿s orders signal the beginning of the appellate process for the $16.35 million judgment (including prejudgment interest) entered Sept. 29, 2000, in favor of the plaintiffs. The lawsuit, which was filed in 1996, alleged that Merck and a non-profit research institution under contract from Merck had infringed various U.S. patents held by The Burnham Institute, of San Diego, that have been licensed to Integra.
¿ NeoPharm Inc. of Lake Forest, Ill., is adding a 34,000-square-foot research and development center in Waukegan, Ill. NeoPharm, which develops new cancer drugs, will leverage its new facility to expand cancer product development activities using its NeoLipid delivery system. The company¿s drug candidates cover the treatment of several different types of cancer including breast, lung, prostate, blood, brain, kidney, mesothelioma and ovarian cancer.
¿ NimbleGen Systems Inc., of Madison, Wis., reported a second closing in its series B financing, bringing the total raised to $10.5 million. On Sept. 11, NimbleGen announced that it raised $9 million in the first closing. Investors included Venture Investors Management LLC, Baird Venture Partners, State of Wisconsin Investment Board, Skyline Ventures, Tactics II Investments LLC and the Wisconsin Alumni Research Foundation. NimbleGen produces custom high- density DNA arrays and is developing DNA array systems based on its Maskless Array Synthesizer technology.
¿ Oxford GlycoSciences plc, of Oxford, UK, said the new drug application for Vevesca (OGT 918), its candidate treatment for Type I Gaucher¿s disease, has been successfully filed under section 505(b) of the Federal Food, Drug and Cosmetic Act. The rolling NDA submission was initiated in March and completed in August. (See BioWorld Today, Aug. 22, 2001.)
¿ Phase 2 Discovery Inc., of Cincinnati, was awarded a $107,090 Phase I Small Business Innovation Research grant from the National Institute of Neurological Disorders and Stroke of the National Institutes of Health. The grant will support the company in developing a serum-based biomarker to predict clinical outcomes and quantify effectiveness of new drugs for treating patients with severe head injury. The biomarker is a derivative of the brain protein MAP-tau, which is primarily localized in neuronal axons.
¿ PPD Inc., of Wilmington, N.C., reported an amendment to the terms of the development and licensing agreement with Eli Lilly and Co., of Indianapolis, on development of therapeutics in the genitourinary field. As announced in 1998, PPD and Lilly entered an agreement giving PPD GenuPro, a wholly owned subsidiary of PPD, worldwide licenses to a number of Lilly compounds in the genitourinary field. Under the amendment, PPD will return to Lilly the license rights to these compounds except for the rights to the compound dapoxetine. PPD had developed dapoxetine to Phase II proof of concept before licensing it to ALZA Corporation in December of 2000. Under the terms of the amendment, PPD will receive an unspecified payment from Lilly in return for relinquishing its rights to the compounds other than dapoxetine.
¿ Tranzyme Inc., of Birmingham, Ala., entered a broad collaboration in bioinformatics and applied genomics with the University of Utah. Tranzyme and the university will develop jointly gene libraries using the sequence database provided by the University of Utah Genome Center. With access to the university¿s library of gene sets, Tranzyme will have the capability to address genetic function while building its applied genomics platform. This platform will employ the company¿s gene delivery and expression technology for gene function discovery, subsequent target validation and assay development for drug discovery.