Aastrom Biosciences Inc., of Ann Arbor, Mich., formalized a European cancer network expected to establish clinical validation of Aastrom’s SC-I bone marrow stem cell product for use in supporting cancer patients who lack sufficient cells for a peripheral blood stem cell transplant. The centers will share a common clinical protocol to treat three to five patients and will cooperate to publish resulting data. Following successful completion of this phase, the centers will be able to use the SC-I product commercially.
Achillion Pharmaceuticals Inc., of New Haven, Conn., began a Phase II study with ACH-126,443 (Beta-L-Fd4C) in patients to treat chronic hepatitis B. The double-blind study will evaluate several doses of ACH-126,443 administered once a day to patients with chronic HBV infection, compared to lamivudine (3TC), and placebo. The study will be conducted in multiple centers in Europe. ACH-126,443 is an L-nucleoside antiviral agent that has demonstrated in vitro activity against both wild-type and lamivudine-resistant strains of HBV.
Amrad Corp., of Victoria, Australia, said that positive findings from its Phase I/II trial in patients with chronic severe pain led to early completion of the study, moving AM336 to the next stage of development additional safety studies and a full Phase II trial, expected to begin this year. AM336 is a synthetic version of the molecule CVID, originally isolated from the venom of a fish-eating species of cone snail from Australia’s Great Barrier Reef. Amrad has exclusive worldwide rights to commercialize the compound.
Avecia Biotechnology Inc., of Billingham, UK, reported that it invested $100 million in a program to build what it said is one of the world’s most advanced biologics medicines manufacturing facilities. The investment will create 40,000 liters of contract manufacturing capacity for microbially derived biologics. Once completed in 2005, Avecia said the facility will be the largest purpose-built facility of its kind in the world.
Boehringer Ingelheim International GmbH, of Ingelheim, Germany, and Chemical Diversity Labs Inc., of San Diego, entered a contract research agreement in which Chemical Diversity will provide chemistry research services to Boehringer Ingelheim Austria GmbH, part of the Boehringer Ingelheim group of companies. Financial terms were not disclosed.
Digene Corp., of Gaithersburg, Md., received clearance by the Japanese Ministry of Health, Labor and Welfare to market its Hybrid Capture 2 HPV Test for the detection of human papillomavirus (HPV) as a follow-up to borderline Pap smear test results. Mitsubishi Kagaku Medical Inc., of Tokyo, a subsidiary of Mitsubishi Chemical Corp., will distribute the test in Japan. Also, Digene filed with the FDA to use its test in conjunction with the Pap smear as a primary screen for cervical cancer and its precursors in women age 30 and older. On Feb. 19, Digene and Cytyc Corp., of Boxborough, Mass., signed a definitive merger agreement in which Cytyc will acquire Digene in a stock and cash tender offer transaction. (See BioWorld Today, Feb. 20, 2002.)
DOR BioPharma Inc., of Chicago, received orphan medicinal product designation from the European Agency for the Evaluation of Medicinal Products for its orBec (beclomethasone dipropionate), for the treatment of intestinal graft-vs.-host disease. In the U.S., where it is in a Phase III trial, orBec received the FDA’s fast-track designation.
D-Pharm Ltd., of Rehovot, Israel, received the first milestone for SPD 421 from Shire Pharmaceuticals Group plc, of Andover, UK, a payment pursuant to the Phase II trial progress of SPD 421 as add-on therapy in the treatment of complex partial seizures. Under the March 2000 agreement, which included a successful Phase I trial in 60 healthy volunteers, Shire is responsible for clinical development and registration of the product. Shire will make cash payments to D-Pharm upon the achievement of certain clinical, regulatory and commercial milestones.
Endovasc Ltd. Inc., of Montgomery, Texas, presented data on Liprostin supporting the safety and potential efficacy of incorporating Prostaglandin E-1 (PGE-1) in a liposomal formulation at an American Association of Pharmaceutical Scientists workshop held in Arlington, Va. PGE-1 is a naturally occurring hormone and vasodilator, platelet inhibitor and antithrombotic. The company expects that Liprostin, the liposomal formulation of PGE-1, enhances the properties of the compound to allow for targeted, local drug therapy in the treatment of cardiovascular disease.
EntreMed Inc., of Rockville, Md., said Endostatin received orphan drug status from the FDA for the treatment of patients with malignant metastatic melanoma. The FDA accepted EntreMed’s Endostatin application upon review of data from preclinical studies and Phase I trials for patients with various advanced cancers. In August, Endostatin received orphan drug status for neuroendocrine tumors, and Endostatin Phase II melanoma trials were initiated in November.
EVIT Labs Inc., of McClellan, Calif., signed a letter of intent with NovaCal Pharmaceuticals LLC, of Novato, Calif., to develop NovaCal’s NVC101 as an inhaled antimicrobial agent delivered by the Sonik LDI (liquid dispensing inhaler) for possible use against certain pulmonary infections. The companies said they are interested in developing NVC101 for the treatment of inhalation anthrax. Lawrence Berkeley National Laboratory, of Berkeley, Calif., will perform initial screening of NVC101 against anthrax. Other potential uses are being explored through joint efforts of NovaCal and EVIT. Terms were not disclosed.
Fred Hutchinson Cancer Research Center, of Seattle, and the University of Washington School of Medicine in Seattle, in collaboration with the University of Pittsburgh School of Medicine, said they mapped the location of a gene associated with inherited pancreatic cancer. Findings will be reported in the electronic edition of the April issue of the American Journal of Human Genetics. Researchers mapped the gene to the long arm of chromosome 4.
Genaera Corp., of Plymouth Meeting, Pa., received a Phase II Small Business Innovation Research grant from the National Institutes of Health, of Bethesda, Md., to develop a small-molecule anti-inflammatory aminosterol therapeutic. The grant, valued at approximately $800,000, will be used to further develop lead compounds.
Immune Network Ltd., of Vancouver, British Columbia, said that as a result of the recent preferred share conversion, the company has undergone a change of control. Hugh Wynne-Edwards, president of Terracy Inc., of West Vancouver, acquired ownership of 69.9 million common shares, representing 36 percent of the total outstanding common shares of Immune Network.
The Immune Response Corp., of Carlsbad, Calif., reported that CD8+ memory T cells showed a statistically significant increase in the Remune group compared to the Incomplete Freund’s Adjuvant control group. There also was a statistically significant improvement in the level of HIV-induced hyperactivation as evidenced by a decrease in activated T cells in the Remune group compared to the IFA control group. The Remune group also showed a statistically significant correlation between cytotoxic T-cell lymphocytes precursors and control of virus in the blood. The data were presented at the ninth Conference on Retroviruses and Opportunistic Infections in Seattle.
Immunomedics Inc., of Morris Plains, N.J., reported the publication of an article on trial results with its radiolabeled, humanized antibody against carcinoembryonic antigen in the Feb. 15 supplement issue to Cancer. The publication reported Phase II results of 30 colorectal cancer patients given the I-131-labeled humanized CEA antibody. Two sets of patients were studied 21 with measurable metastatic colorectal cancer and nine who had their metastases resected prior to therapy. Of 19 patients in the first group, three experienced a partial remission and eight showed minor responses. Seventy-eight percent of the patients in the second group remained free of the disease for up to 36 months.
Neoprobe Corp., of Dublin, Ohio, said its subsidiary, Biosonix Ltd., received FDA marketing approval for its diagnostic product, FlowGuard. It was approved to determine blood flow in noninvasive diagnostic and intraoperative applications. FlowGuard received CE mark clearance from European regulatory agencies late last year.
Northwest Biotherapeutics Inc., of Bothell, Wash., said the investigational new drug application for its third dendritic cell-based immunotherapy, DCVax-Lung, was cleared by the FDA. Northwest expects to begin a Phase I trial to evaluate the safety of DCVax-Lung as a potential treatment for non-small-cell lung cancer patients later this year, the company said.
Novartis AG, of Basel, Switzerland, said that results of a Phase II study of Gleevec were published in the Feb. 27 issue of The New England Journal of Medicine. The study demonstrated that Gleevec (imatinib mesylate) induces higher hematologic and cytogenic response rates than previously reported in patients in the chronic phase of chronic myeloid leukemia (CML) who have been treated unsuccessfully with interferon-alpha. The new data, based on a median follow-up of 18 months, indicate that response rates to Gleevec increased in CML patients taking the drug early in their disease.
Sequitur Inc., of Natick, Mass., began selling its RNA Catcher, a high-throughput mRNA isolation system that allows for mRNA samples to be analyzed by reverse transcription and quantitative PCR (RT-PCR). The RNA Catcher isolates mRNA through RNA binding to oligo-dT immobilized on a 96-well plate. Sequitur is offering the RNA Catcher for research use as a stand-alone kit with no licensing fees.
Stratagene Inc., of La Jolla, Calif., said the Court of Appeals for the Federal Circuit ruled in its favor in an appeal from a Maryland District Court’s decision in patent infringement litigation with Invitrogen Corp., of San Diego. Invitrogen requested that Stratagene be forced to remove its RNase H minus reverse-transcriptase enzyme from the market. The District Court not only denied Invitrogen’s request, but also put the case on hold pending the outcome of a related case between Invitrogen and Clontech Laboratories Inc., of Palo Alto, Calif.
Symbiontics Inc., of St. Louis, achieved a milestone in the development of its glycosylation independent lysosomal targeting modification technology for enzymes, which is designed to enable the trafficking of such enzymes both to specific cell types and to lysosomes within those cells. Scientists demonstrated about a 100-fold increase in specific uptake of a GILT-modified enzyme into cultured cells compared with uptake of an unmodified enzyme. The company first intends to apply GILT technology to the treatment of lysosomal storage diseases.
Syncor International Corp., of Woodland Hills, Calif., entered an agreement with IDEC Pharmaceuticals Corp., of San Diego, in which Syncor will prepare and distribute patient-specific doses of Zevalin (ibritumomab tiuxetan), a radioimmunotherapy recently FDA approved for the treatment of certain non-Hodgkin’s lymphomas. Syncor will provide patient-specific Zevalin dose preparation and delivery services to qualified licensed hospitals and physicians from its network of 131 nuclear pharmacies. Terms were not disclosed.
Syrrx Inc., of San Diego, formed a research collaboration with Metaphorics LLC, of Mission Viejo, Calif., to improve computational tools for docking ligand molecule structures into protein binding sites. The companies expect to create new software to improve the ability to predict the potential complements between ligands and proteins. Metaphorics will provide informatics knowledge relating to its distance geometry-based suite of programs. Financial details were not disclosed.
Transgene SA, of Strasbourg, France, initiated a Phase II trial of its immunotherapeutic MVA-HPV-IL2 vaccine candidate for the treatment of Stage II/III cervical intraepithelial neoplasia. The trial will be conducted at six sites in France and will include up to 28 women.
ViroLogic Inc., of South San Francisco, said data presented at the ninth Conference on Retroviruses and Opportunistic Infections in Seattle, demonstrate guidance benefits of PhenoSense GT, its combination HIV drug-resistance test. Researchers reported that combining results from two types of HIV drug-resistance testing phenotypic and genotypic can provide information to select optimal HIV treatment regimens. PhenoSense GT provides physicians with all available drug resistance information in one report, the company said. Separately, the company said results from a new study demonstrate that antibodies generated in response to HIV infection play a role in the body’s effort to fight the virus. The discovery was made using ViroLogic’s entry inhibitor assay.