AGY Therapeutics Inc., of South San Francisco, began drug discovery programs for two ischemic stroke drug targets, AGY-203 and AGY-207. The proteins belong to different druggable classes of intracellular enzymes, but their involvement in stroke was previously unknown. AGY identified and validated the candidates with its imagine research platform, and expects to produce small-molecule drug candidates in the second half of this year.
AnVil Informatics Inc., of Burlington, Mass., said it formed a pilot project with Genomics Collaborative Inc., of Cambridge, Mass., to apply AnVil’s analysis and visualization knowledge and tools to GCI’s DNA microarray data. The project is designed to develop integrated visual analytic systems to identify gene expression patterns. Financial terms were not disclosed.
Avigen Inc., of Alameda, Calif., said preclinical studies show that an adeno-associated virus (AAV) vector may be effective in the treatment of hemophilia A. Scientists presented the data at the National Hemophilia Foundation’s fifth annual workshop on gene therapies for hemophilia, held in Philadelphia. Preclinical studies in both hemophilic mice and dogs showed that a single injection of AAV vector containing the gene for FVIII could achieve long-term expression of the clotting factor. The research was conducted by a team of scientists from Queen’s University of Kingston in Canada, Children’s Hospital of Philadelphia, the University of Pennsylvania, Stanford University and Avigen.
AxCell Biosciences, of Newtown, Pa., a subsidiary of Cytogen Corp., signed a term sheet with the University of Muenster in Germany to research protein interactions associated with an undisclosed gene believed to play a role in neurodegenerative diseases. The parties agreed that intellectual property derived from the collaboration would be the joint property of AxCell and the university, with AxCell retaining an option to negotiate an exclusive worldwide, royalty-bearing license from the university for any and all joint intellectual property.
Biopure Corp., of Cambridge, Mass., sold to undisclosed institutional investors approximately 2.8 million shares of common stock at $7.50 each for gross proceeds of about $20.7 million. Biopure will use the estimated net proceeds of $19.7 million for general corporate purposes including capital expenditures and to meet working capital needs. Biopure develops oxygen therapeutics that are intravenously administered to deliver oxygen to the body’s tissues.
BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., reported at the American Association of Pharmaceutical Scientists meeting on pharmaceutics and drug delivery in Arlington, Va., positive results of preclinical testing of its calcium phosphate (CAP) delivery system for the oral delivery of insulin. When administered into the stomach, the formulation reduced blood glucose levels by 80 percent within the first hour, levels that were maintained throughout the 12-hour blood-sampling period. The same amount of insulin alone reduced glucose levels by 20 percent in the first hour and by 35 percent within five hours, after which time blood glucose increased sharply to baseline.
Bio-Technology General Corp., of Iselin, N.J., appointed Christopher Clement president and chief operating officer, effective May 14. Previously, he was the CEO and chairman of Epicyte Pharmaceutical Inc., of San Diego. Bio-Technology General develops genetically engineered and other products for human health care.
Chromos Molecular Systems Inc., of Burnaby, British Columbia, and MorphoGen Pharmaceuticals Inc., of San Diego, formed a collaboration in which Chromos will employ MorphoGen’s adult-derived stem cells to expand application of Chromos’ gene delivery and expression technology for cell-mediated gene therapies. Financial terms of the agreement were not disclosed. The objective of the collaboration is to demonstrate the ability of engineered chromosomes to be transferred into adult-derived stem cells to replicate and express proteins as the stem cells multiply and differentiate into specific cell types.
Deltagen Inc., of Redwood City, Calif., said CEO William Matthews will take on additional duties as chairman. Deltagen also appointed Michael Sember president and chief operating officer. Both moves are effective immediately. Matthews, a co-founder of Deltagen, was appointed president in 1997 and became CEO in 1998. Sember previously was the executive vice president of business development at Elan Corp. plc, of Dublin, Ireland. Through its target research and development program, Deltagen established secreted protein and small-molecule discovery programs in the areas of oncology, metabolic disorders and inflammatory diseases.
Dendreon Corp., of Seattle, said the FDA granted orphan drug status to its therapeutic vaccine for multiple myeloma, Mylovenge, making Dendreon eligible for tax credits for related clinical development costs and assistance from the FDA in the regulatory review and approval process. Preliminary results of two recently completed clinical trials of Mylovenge, which is in Phase II studies, suggest that treatment is safe, and that it may stimulate immune activity and cause disease regression or stabilization.
Entelos Inc., of Menlo Park, Calif., and N.V. Organon, of Oss, the Netherlands, said they completed the first-ever, large-scale computer model of rheumatoid arthritis that simulates patient response to treatment. Completion and delivery of the Entelos Rheumatoid Arthritis PhysioLab technology to Organon triggers an undisclosed milestone payment. Entelos RA PhysioLab technology is a mathematical model of a single prototypical human joint displaying active, early stage rheumatoid arthritis with chronic inflammation and cartilage degradation.
Genomatica Inc., of San Diego, entered exclusive license agreements with The University of California at San Diego and Pennsylvania State University, giving Genomatica what it called a dominant patent position in the areas of constraints-based modeling of metabolism and its associated regulatory processes. In the University of California agreement, Genomatica will have broad, exclusive rights to seven inventions. The technology licensed from Penn State encompasses a patent application involving the study and determination of optimal performance characteristics of biochemical reaction and regulatory networks.
Glaucus Proteomics BV, of Utrecht, Netherlands, entered agreements with SARA, one of Europe’s largest supercomputing facilities, and GigaPort, an Internet initiative that provides a broadband network. Both companies are located in the Netherlands. The agreements are expected to provide the biocomputing capacity and connectivity to help Glaucus with the development of tools and technologies for high-throughput proteomic analysis and the screening of antibody and small-molecule drug candidates for improved specificity.
Immtech International Inc., of Vernon Hills, Ill., said it received approval from the Government of Peru to begin a Phase II trial of DB289 for the treatment of pneumocystis carinii pneumonia (PCP). The trial is scheduled to begin in May. DB289 was developed and supported by a National Cooperative Drug Development grant from the National Institutes of Health, of Bethesda, Md. Peru is a second site enrolling patients in clinical trials, the first being South Africa. Initial patients will be enrolled in the trial if they are intolerant or cannot be treated with trimethoprim-sulfamethoxazole, the standard treatment for PCP.
Large Scale Biology Corp., of Vacaville, Calif., said Plurigen CM is available to selected organizations for the purpose of further expanding the applications and utilities of the product. Each collaborative agreement would allow users to evaluate Plurigen CM under a time-limited, site-specific license using biological models of its own choosing. LSBC’s Plurigen CM is a stabilized formulation of hematopoietic growth factors exhibiting proliferative activity on a variety of stem and progenitor cells.
Oxford GlycoSciences plc, of Oxford, UK, said it was informed that a 66-year-old patient, formerly in the OGT 918-001 trial, who continued in the extended-use capture protocol but stopped treatment with OGT 918 in October, developed cognitive dysfunction of unknown cause. The patient is still under investigation and a diagnosis has not been established yet. The ethics committee in Israel abstained from expressing any opinion about a possible relationship until the results of the ongoing tests are obtained, but recommended that OGT 918 administration be temporarily stopped as a precaution. A new drug application was submitted to the FDA in August for OGT 918 for Type I Gaucher’s disease. OGT 918 also is in clinical trials for the treatment of Fabry’s disease.
Oxigene Inc., of Watertown, Mass., said findings from a preclinical study identifying its lead vascular targeting agent, Combretastatin A4 Prodrug (CA4P), as a potential combination therapy with chemotherapeutic agents for the treatment of breast and ovarian cancer will be published in the May edition of the International Journal of Cancer. CA4P, among other things, appeared to enhance the ability of cisplatin to kill tumor cells at all doses studied, with the degree of efficacy dependent on the sequence and interval between the agents.
Pharmacyclics Inc., of Sunnyvale, Calif., reported at this week’s 49th meeting of the Radiation Research Society in Reno, Nev., evidence that the mechanism of action of its lead product, Xcytrin (motexafin gadolinium), enhances the effects of radiation and chemotherapy for the potential treatment of cancer and other diseases. Results show that Xcytrin has direct effects on tumor cells independent of radiation that lead to changes in cellular morphology, cellular adhesion and cytotoxicity. It also induces expression of several genes involved in cellular response to oxidative stress and energy metabolism, and it inhibits the cellular enzyme called thioredoxin reductase, the company said.
Select Therapeutics Inc., of Woburn, Mass., said it is focusing its business on cytotoxic cancer therapy and its cancer immunotherapy programs. As part of this, a restructuring program was implemented. Select satisfied a portion of its liabilities by converting approximately $851,000 of liabilities into about 4.9 million shares of restricted common stock in a series of negotiated transactions that ended April 19. The company also is negotiating the sale of certain intellectual property rights in a non-core area. Select commenced a private offering of up to 17 million shares of its common stock at 15 cents per share to accredited investors. These transactions are expected to provide the company with operating funds, which it believes are sufficient to meet its projected expenditures for approximately 18 months. Select intends to use the proceeds to initiate its clinical development program for VeroPulse (VT-1) and to complete a preclinical program for at least one of its VeroVax or Activate cancer vaccine programs, with the intent of commencing clinical development during the next 12 to 18 months. Select announced the resignation, effective May 20, of Robert Bender as chairman and a director, and Andrew Muir is scheduled to resign as CEO and will become chairman. Craig Sibley, a founder and former board member, was appointed president and CEO. Select’s stock (AMEX:XZL) rose 17 cents Wednesday, or 94.4 percent, to close at 35 cents.
Senesco Technologies Inc., of New Brunswick, N.J., said it closed its ongoing private placement of restricted equity securities. The company raised a total of about $3.5 million. Its main technology regulates the onset of cell death, and the company is evaluating the technology in both plant and human applications. (See BioWorld Today, April 19, 2002.)
The Immune Response Corp., of Carlsbad, Calif., said it received a $100,000 milestone payment from NovaRx Corp., of San Diego. The payment was triggered when NovaRx enrolled the first patient in a Phase II trial of an experimental cancer vaccine in individuals with lung cancer. NovaRx is a licensee of one of The Immune Response’s patents in the cancer vaccine field, for which it received an equity stake in NovaRx. The cell-based vaccine being studied contains non-small-cell lung cancer cell lines that have been genetically modified to express an antisense DNA molecule that binds to the gene producing transforming growth factor B.
Third Wave Technologies Inc., of Madison, Wis., said it will expand its sales and marketing presence and continue its ongoing product development activities as a way of simplifying its product development and manufacturing operations. It also will reduce its work force by approximately 25 percent, thereby lowering capital needs. Third Wave also said it anticipates that its total revenue for the first quarter ended March 31 will exceed $10 million. Third Wave develops, manufactures and markets genetic analysis products used in the discovery and validation of the genetic basis of disease and the delivery of personalized medicine. Its stock (NASDAQ:TWTI) fell 27 cents Wednesday, to close at $3.05.
Valentis Inc., of Burlingame, Calif., said its wholly owned subsidiary, PolyMASC Pharmaceuticals plc, was granted European Patent No. EP572,049B1, covering PEGylated liposomes. Also, PolyMASC initiated infringement proceedings in Germany, against SP Labo NV, SP Europe and Essex Pharma GmbH, all members of the Schering Plough Group. The suit alleges infringement of the new patent and patent EP445,131B1, also owned by PolyMASC, based on the sales of Caelyx, a PEGylated-liposome product encapsulating doxorubicin. Valentis focuses on converting genomic discoveries into medicines.
VaxGen Inc., of Brisbane, Calif., said the seventh review of the Phase III trials of VaxGen’s preventive AIDS vaccine candidates resulted in an independent Data and Safety Monitoring Board finding that the vaccine candidates continue to exhibit a strong safety profile. Since human trials first began, more than 32,000 injections have been administered. Two formulations are being tested in separate trials AIDSVax B/B in North America and Europe and AIDSVax B/E in Thailand involving a total of nearly 8,000 volunteers. The final analysis of the trial in North America and Europe for AIDSVAX B/B is planned for the first quarter of 2003. The final analysis of the Thai trial is planned for 2003’s fourth quarter.
Vertex Pharmaceuticals Inc., of Cambridge, Mass., and Aventis Pharma AG, of Frankfurt, Germany, said they are expanding development of the interleukin-1 beta converting enzyme inhibitor pralnacasan, based on data from a Phase II trial in rheumatoid arthritis (RA). Vertex said data supports development in rheumatoid arthritis, as well as Phase II trials in osteoarthritis and other indications. Aventis will evaluate the timing of such trials, Vertex said. Results from the RA trial showed that patients receiving pralnacasan had a trend toward a dose-dependent improvement in signs and symptoms of disease, as measured by ACR20 response rates after 12 weeks. However, the p-value=0.076. Vertex’s stock (NASDAQ:VRTX) fell $5.35 Wednesday, or 18.6 percent, to close at $23.41.
ViroLogic Inc., of South San Francisco, signed an expanded agreement with GlaxoSmithKline plc, of London, to use ViroLogic’s HIV resistance testing technology in the Phase III development of an investigational HIV protease inhibitor. GSK will use ViroLogic’s PhenoSense HIV and GeneSeq HIV assays in its Phase III trials to evaluate drug resistance in more than 1,000 adult and pediatric patients receiving antiretroviral drug cocktails containing the investigational compound. Financial terms were not disclosed.