Anosys Inc., of Menlo Park, Calif., reported Phase I results of its cancer vaccine, called acellular anticancer dexosomes, to treat melanoma. Data show that three of six patients who received an active dose of the vaccine (dexosomes loaded with 100 ug/mL tumor-specific peptide) achieved clinical benefit, either prolonged disease stabilization up to 12 months (two patients) or tumor shrinkage (one patient). A cytotoxic T-cell response was detected in five patients following immunotherapy.
Astex Technology Ltd., of Cambridge, UK, entered a drug discovery collaboration in the area of metabolic disorders with Mitsubishi Pharma Corp., of Tokyo. The collaboration was established to identify lead compounds against a protein target, and will then be extended to other targets. Astex will apply its high-throughput X-ray crystallography and Pyramid approach to fragment-based drug discovery against the target to identify drug candidates. Astex's structural screening approach will use the protein crystal structure of the target to detect the binding of drug fragments, which will then be optimized into lead compounds for subsequent clinical development by Mitsubishi. Financial terms of the agreement were not disclosed.
Celgene Corp., of Warren, N.J., advanced its lead JNK (c-Jun-N-terminal Kinase) inhibitor, CC-401, into clinical testing. The Phase I, double-blind, placebo-controlled, ascending single-intravenous-dose study is evaluating the safety and tolerability of CC-401 in healthy human volunteers. Following completion of the study, Celgene will evaluate CC-401 as a potential therapy in acute immunological indications. The JNK gene regulation pathway has been shown to play a role in the onset and progression of diseases that involve inflammation, cell death, ischemia/reperfusion injury and cellular proliferation, the company said.
Columbia Laboratories Inc., of Livingston, N.J., said the FDA accepted for review its new drug application for its Striant buccal bioadhesive product, a controlled- and sustained-release product containing 30 mg of testosterone. The company is seeking approval of Striant for the treatment of hypogonadism in men.
Endovasc Ltd. Inc., of Montgomery, Texas, entered an agreement under which Cardinal Health Inc., of Dublin, Ohio, will formulate Angiogenix according to cGMP FDA standards. Cardinal has received USP-grade nicotine from the University of Kentucky, where it was stored after completing the Phase II trials. Financial terms were not disclosed.
Epimmune Inc., of San Diego, and Genencor International Inc., of Palo Alto, Calif., extended their collaboration focused on the development of vaccines to treat or prevent the hepatitis C, hepatitis B and human papilloma viruses. Begun in July 2001, the agreement had an initial term through September 2003 but was extended 12 months. Genencor fully funds Epimmune's R&D expenses and will pay Epimmune royalties on sales of any resultant products. Also, Genencor would make milestone payments to Epimmune upon successful completion of certain development and pre-commercial milestones.
Florida said it made available specialized incentives and tax credits to medical device manufacturers, and biotechnology and pharmaceutical companies. The incentives are a capital investment tax credit and a high-impact performance incentive.
High Throughput Genomics Inc., of Tucson, Ariz., said it tripled the size of its facilities. The firm said the added space would increase its manufacturing facilities and expand R&D and marketing staff to support new product development.
IGEN International Inc., of Gaithersburg, Md., said the Bloodborne Pathogens and Hepatitis Lab of Health Canada developed an ultra-sensitive test for the detection of hepatitis B virus mutants using the company's Origen technology. IGEN said its technology could provide a diagnostic tool in identifying conditions such as an infant breakthrough infection from a pregnant HBV carrier patient or post-transplantation relapse of liver transplant patients.
SangStat Medical Corp., of Fremont, Calif., named board member Richard Murdock its interim chairman, president and CEO, replacing Jean-Jacques Bienaime, who will resign next month and move to Genencor International Inc., of Palo Alto, Calif., though he will remain a SangStat board member.
Maxim Pharmaceuticals Inc., of San Diego, said clinical researchers presented updated results from its Phase III trial of Ceplene (histamine dihydrochloride) in combination with interleukin-2 for the treatment of advanced metastatic melanoma patients, during the 27th European Society of Clinical Oncology conference in Nice, France. The rate of three-year survival for patients treated with the Ceplene/IL-2 combination was about two times the rate of survival for control patients. The 36-month data also demonstrated that the combination significantly increased survival in the subpopulation of advanced metastatic melanoma patients with liver metastases (p=0.003). A Maxim officer said the company will need a second trial to confirm the first trial's results, and the second trial is expected to be completed in early 2005, at which point the existing NDA will be amended.
NeoPharm Inc., of Lake Forest, Ill., and its collaborators unveiled preliminary data from the company's Phase I study of Liposome Encapsulated Mitoxantrone in patients with advanced cancers, at the 27th European Society of Clinical Oncology conference held in Nice, France. The objectives of the study were to determine the maximum tolerated dose, dose-limiting toxicity, pharmacokinetic parameters and preliminary treatment effect for LEM in patients with incurable advanced local or metastatic solid tumors. The LEM abstract showed that infusions were well tolerated at 21-day intervals, without hypersensitivity reaction. Plasma PK measurements were relatively similar across all dose levels, with neutropenia being the primary dose-limiting toxicity.
NPS Pharmaceuticals Inc., of Salt Lake City, said it executed a binding letter of intent with Boehringer Ingelheim Austria GmbH, of Vienna, Austria, for Boehringer to manufacture commercial quantities of bulk drug supplies of Preos, NPS' product for the treatment of osteoporosis. It also reported top-line data from the last two patient cohorts in a Phase II study of ALX-0600, its product designed to treat gastrointestinal disorders. Data from the first three patient cohorts were presented earlier this year. The fourth patient cohort comprised participants from the first three groups who underwent a drug wash-out period, and were then re-challenged with ALX-0600. These patients responded positively to the new administration of drug, and did not develop antibodies to ALX-0600, the company said. The fifth and final patient group comprised people with some functioning colon capable of providing minimal quantities of native glucagon-like peptide 2, the naturally occurring hormone that ALX-0600 is intended to replace or supplement. Those patients also responded positively to the drug with indications of improved nutrient and energy absorption.
Parker Hughes Center for Clinical Immunology in Roseville, Md., said it developed Stampidine, a drug designed to fight AIDS. The drug was examined in test tubes against drug-resistant HIV isolates from 29 HIV-infected individuals. Stampidine was effective against AIDS strains from Europe and the U.S. The product was then evaluated in mice infected with a drug-resistant, human AIDS virus strain from Brazil and found to be more effective than AZT, the center said. The results of the studies will be reported in the Nov. 1, 2002, issue of Antimicrobial Agents and Chemotherapy.
Procyon Biopharma Inc., of Montreal, said it and Chiron Corp., of Emeryville, Calif., mutually agreed not to extend the license option agreement and the further development of the recombinant form of PSP94 (prostate secretory protein) for the treatment of prostate cancer. Procyon will continue with the development program using PCK3145, a synthetic peptide analogue of PSP94. Phase IIa trials are under way in the UK for the treatment of late-stage, hormone-refractory prostate cancer. Also, Procyon is developing diagnostic/prognostic tests based on the PSP94 technology for the detection of aggressive prostate cancer. The original agreement was signed in January.
VaxGen Inc., of Brisbane, Calif., said the board that oversees its clinical trials completed the final safety and conduct review of its Phase III trial in Thailand and once again concluded that the study was being conducted appropriately and that VaxGen's AIDS vaccine candidate appears safe. In its seventh review of the Thai trial, the Data and Safety Monitoring Board found that the AIDS vaccine candidate, AIDSVAX B/E, continues to exhibit a good safety profile, the company said. The DSMB also conducted an interim analysis of efficacy using data from the trial in Thailand and recommended that the study continue to its planned conclusion in the second half of 2003.
ViroLogic Inc., of South San Francisco, entered an agreement with Surveillance Data Inc., of Plymouth Meeting, Pa., to create a line of HIV market research products based on data collected through ViroLogic's HIV resistance testing and therapy guidance business. Resultant products are designed to allow pharmaceutical and biotech companies to purchase data on drug resistance trends and demographics. Financial terms were not disclosed.