¿ Aradigm Corp., of Hayward, Calif., said it initiated a Phase IIb clinical trial of AERx, a pulmonary drug delivery system, using opioid analgesics for patients in their homes. Aradigm is developing the pain management system with partner SmithKline Beecham Inc., of London. The multicenter trial involves self-administered morphine via inhalation through the AERx system. Patients suffer from pain due to cancer, and the trial is designed to evaluate safety, pain relief, time to pain relief and quality of life.
¿ BioStar Inc., of Boulder, Colorado, granted Agouron Pharmaceuticals Inc. a non-exclusive license, with a specified field of use, for BioStar's recently patented technology for optical detection of nucleic acids. The new licensing is an amendment to an earlier agreement with Agouron and includes applying BioStar's nucleic acid technology to DNA arrays for the detection of specific analytes in PCR products from clinical samples. Also, there is an extension of a collaboration to examine the feasibility of using BioStar's OIA optical detection technology to address certain diagnostic applications.
¿ Calydon Inc., of Sunnyvale, Calif., began testing an experimental drug in men with metastatic prostate cancer who have failed hormone therapy. The drug, CV787, has been engineered as a cancer-killing virus that preferentially replicates in, and kills, human prostate cancer cells 10,000 times more frequently than normal cells. Investigators will be enrolling up to 48 patients for the Phase I/II multicenter, open-label, dose-finding study to test the safety, tolerability and PSA efficacy of the drug.
¿ Celera Genomics, of Rockville, Md., and ValiGen N.V., of Rotterdam, the Netherlands, entered a five-year genomics agreement. ValiGen will receive a subscription to all of Celera's current integrated database products, bioinformatics systems and other discovery tools. ValiGen researchers will access these products through the web-based Celera Discovery System. Financial terms of the agreement were not disclosed.
¿ ChemDiv Inc., of San Diego, agreed to provide Bristol-Myers Squibb Co., of Madison, N.J., access to CombiLab, a set of experimentally confirmed, optimized combinatorial libraries of small-molecule compounds for screening and lead optimization. ChemDiv will be paid for delivery of several dozen compound libraries of its CombiLab set. Although no financial information was released, the agreement allows for Bristol-Myers to acquire additional compounds, chemistry services or lead optimization in the future.
¿ Commonwealth Biotechnologies Inc., of Richmond, Va., completed a $2.6 million private placement of common stock and warrants to purchase common stock. The company recently entered an alliance with Kemp Biotechnologies Inc., of Frederick, Md., to offer large-scale bioprocessing services.
¿ Diacrin Inc., of Charlestown, Mass., said a physician with Temple University Hospital, a Diacrin collaborator, transplanted a patient's own skeletal muscle cells (autologous myoblasts) directly into a damaged area of the patient's heart in a Phase I trial designed to test the feasibility and safety of transplanting skeletal muscle cells into a heart and to gain preliminary information on the survival and potential cardiac function value of such a transplant. The first patient to participate in the trial was a 48-year-old Norristown, Pa., resident, whose arm muscle cells were isolated and expanded in culture for transplant two weeks later during surgery to implant a left ventricular assist device. The patient currently uses the assist device and is awaiting a heart transplant. Researchers will evaluate the skeletal cells' survival after transplantation.
¿ EntreMed Inc., of Rockville, Md., initiated its fourth Phase I clinical trial of Endostatin, a naturally occurring inhibitor of angiogenesis. This study is designed to explore the use of continuous infusion and subcutaneous administration of the drug. The company received authorization from the Institutional Review Board at the Free University Academic Hospital in Amsterdam, the Netherlands, to conduct the study, the first on Endostatin in Europe.
¿ Epimmune Inc., of San Diego, said it expanded its collaboration with the Naval Medical Research Center Malaria Program to apply its functional genomics technology to the malaria genome. ImmunoSense, Epimmune's genomic data analysis tool, will identify antigens from raw genomic data in an effort to formulate a vaccine.
¿ Garden State Cancer Center, of Belleville, N.J., responded to FDA concerns in relation to a Morris Plains, N.J.-based Immunogenics Inc. trial suspended by the FDA. The center claims "virtually all the issues raised by the FDA involve paperwork." It also expressed confidence about the level of professionalism, safety and concern with which it works. The center added that Quintiles Transnational Corp. has been retained to improve the center's clinical trial monitoring.
¿ Genta Inc., of Berkeley Heights, N.J., completed its second out-licensing agreement for antisense patents to Oasis Biosciences Inc., of San Diego. The non-exclusive license agreement includes up-front payments in cash and royalties on product sales.
¿ Hybrigenics SA, of Paris, launched its hepatitis C PIMRider, a new database dedicated to the identification of new targets against the hepatitis C virus. The first subscriber to the PIMRider is XTL Biopharmaceuticals Ltd., of Rehovot, Israel, a company working on hepatitis drugs. The companies currently are working together to discover new drugs for hepatitis C.
¿ Iomed Inc., of Salt Lake City, said next month it will begin a Phase III confirmatory study of its non-invasive, site-specific delivery system Phoresor for treatment of acute local inflammation using dexamethasone. The 300-patient study will focus on patients with epicondylitis, and is expected to be completed by next year, when Iomed plans to file an NDA with the FDA. The company anticipates marketing the combo, dubbed ProDex, in clinics in 2002.
¿ Isis Pharmaceuticals Inc., of Carlsbad, Calif., said Coley Pharmaceutical Group Inc., of Wellesley, Mass., acquired a family of patents relating to immune stimulatory and modulatory phosphorothioate oglionucleotide technology for use in Coley's oligonucleotide technology to enhance novel CpG-based products as cancer, asthma, allergy and infectious diseases therapies. Isis will receive $10.7 million for the two U.S. patents and a pending patent as a prepayment of all future royalties and milestones related to a former agreement. Some $3.7 million of the fee will repurchase Coley preferred stock granted to Isis in the previous agreement, under which Isis received $5 million in cash and preferred stock.
¿ Myriad Genetics Inc., of Salt Lake City, launched its Colaris predictive medicine test for hereditary colon cancer. The test works by detecting disease-causing mutations in the MLII1 and MSII2 genes, which increase an individual's risk for colon cancer by 40 times.
¿ Orchid BioSciences Inc., of Princeton, N.J., said subsidiary GeneScreen was one of three firms awarded a contract with the City of New York to screen criminal evidence and generate DNA samples. GeneScreen began operations in 1987 and performs genetic diversity analyses for forensic and identity testing, improved transplantation of bone marrow and organs, and pharmacogenetics testing in support of clinical studies.
¿ OSI Pharmaceuticals Inc., of Uniondale, N.Y., said its board of directors adopted a shareholder rights plan in a move to protect shareholders in case of an unwanted takeover attempt.
¿ Panacea Pharmaceuticals Inc., of Rockville, Md., completed a Series A round of financing. Proceeds of the offering, the total of which was not disclosed, will be used to conduct preclinical studies on PAN-346, the company's lead drug candidate for brain tumors, and also to develop and commercialize its existing cancer diagnostic portfolio.
¿ Pharmos Corp., of Iselin, N.J., said results of a new analysis of its recently completed Phase II dose-escalating trial of dexanabinol in severe traumatic brain injury showed the drug improved orientation and memory among conscious patients, reduced 10-day brain-related mortality by 50 percent and significantly prevented the elevation of intracranial pressure.
¿ SciClone Pharmaceuticals Inc., of San Mateo, Calif., said Peru expanded Zadaxin's approval to include the treatment of hepatitis C as well as previously approved hepatitis B. Zadaxin is approved for sale in 20 countries, principally for the treatment of hepatitis B and hepatitis C as a vaccine adjuvant for patients with weakened immune systems, and SciClone plans to start a Phase III hepatitis C program in the Unites States and Europe by the end of the year.
¿ SuperGen Inc., of San Ramon, Calif., said its board of directors authorized a stock repurchase program of up to 1 million shares of common stock. The company will use existing funds to finance the repurchase.
¿ Zarix Inc., of Berwyn, Pa., initiated patient enrollment in its pivotal Phase III randomized study in patients with unresectable hepatocellular carcinoma comparing treatment of its product, Thymitaq, to doxorubicin. Thymitaq is a novel TS inhibitor antimetabolite that is being developed by Zarix to treat several different cancers. Unresectable hepatocellular carcinoma is the lead indication being pursued.