¿ Actelion Ltd., of Allschwil, Switzerland, said the FDA¿s Renal Drugs Advisory Committee will review its application for Tracleer, its pulmonary arterial hypertension therapeutic, on Aug. 9. Actelion filed for marketing approval for Tracleer in the U.S. in the fall of 2000. The drug is partnered with Genentech Inc., of South San Francisco.
¿ Aphios Corp., of Woburn, Mass., and ITC/Immune Technology, of San Jose, Calif., entered an exclusive worldwide development, manufacturing and commercialization collaboration centered on a natural therapeutic for hepatitis C. The companies will share costs and revenues associated with research, development and marketing. Further financial details were unavailable.
¿ Amylin Pharmaceuticals Inc., of San Diego, said its diabetes candidate, AC2993, produced a statistically significant lowering of fructosamine in a 28-day study in people with Type II diabetes who were not achieving adequate blood glucose target levels through their current oral therapies. Amylin said all the AC2993 dosing arms achieved a statistically significant improvement in glycated hemoglobin levels compared to controls. Full results from the study will be presented at the American Diabetes Association¿s annual meeting on Sunday.
¿ Avax Technologies Inc., of Kansas City, Mo., said an animal model study of its novel anti-estrogen compound alone and in combination with Tamoxifen indicated the compound, 6-MCDF, maintained the positive effects of Tamoxifen while reducing Tamoxifen¿s potential side effects, including uterine hyperplasia and endometrial cancer. Study results were consistent with previous studies that demonstrated that 6-MCDF blocks the uterotropic effects of estrogen in a dose-dependent fashion.
¿ BioPhage Inc., of Montreal, received the final portion of a private placement with Quebec and offshore investors. The 4.7-million-share offering at C$0.5374 per share grossed the company C$2.6 million (US$1.7 million). BioPhage, which develops therapeutics for antibiotic-resistant infections in livestock and humans, granted investors and consultants warrants that entitle them to purchase an additional 4.7 million shares at C$0.5915 per share until April 25, 2002. Proceeds from the offering are earmarked for research and development programs as well as general corporate purposes.
¿ BioTrove Inc., of Cambridge, Mass., received a $1.99 million Advanced Technology Program award from the National Institute of Standards and Technology. The award is to fund engineering efforts related to BioTrove¿s Living Chip technology for massively parallel screening.
¿ Compugen Ltd., of Tel Aviv, Israel, said it will offer two new proteomics tools for researchers, ProtoCall, a web-based mass spectrometry protein identification and characterization system, and a new-version Z3 2D-Gel high-throughput system for comparative analysis of protein expression. Compugen disclosed the new tools¿ availability at the Beyond Genome conference in San Francisco.
¿ CuraGen Corp., of New Haven, Conn., and Bayer AG, of Leverkusen, Germany, said they have jointly selected 12 targets for drug screening pursuant to the $1.4 billion alliance the companies entered in January. The targets were all identified using CurGen¿s drug discovery platform. The targets can potentially be developed into novel treatments for obesity and diabetes. (See BioWorld Today, Jan. 17, 2001.)
¿ DoubleTwist Inc., of Oakland, Calif., said Boehringer Ingelheim International GmbH, of Ingelheim, Germany, licensed DoubleTwist¿s Clustering and Alignment Tools (CAT). CAT allows users to cluster and align large volumes of expressed sequence tags and mRNA sequences into full-length gene sequences suitable for indexing and other drug discovery applications.
¿ GenVec Inc., of Gaithersburg, Md., and the Biosynergy unit of Varian Medical Systems Inc., of Palo Alto, Calif., said they entered a collaborative agreement combining advances in gene therapy products with targeted radiation therapy for treatment of cancer. A Phase IIb trial of the combined treatment modalities was initiated in February. The companies entered the agreement in 1998, and the extension will last through 2004.
¿ Human Genome Sciences Inc., of Rockville, Md., and officials from the federal government, Maryland and Montgomery County broke ground on the $250 million first phase of HGS¿s new research and development and corporate campus. The 55-acre campus will hold several buildings, all connected, and total more than 1 million square feet.
¿ Hybrigen Inc., of Dallas, and Automated Cell Inc., of Pittsburgh, began a drug target discovery and validation program to discover and validate 12 drug targets in autoimmune diseases over the next year. The companies will co-own the targets the program develops. Further financial details were unavailable.
¿ Ligand Pharmaceuticals Inc., of San Diego, said it will present major advances related to the estrogen, androgen and glucocorticoid receptors at the Endocrine Society¿s annual meeting in Denver. Data will be presented, Ligand said, for LGD2226, a small-molecule selective androgen receptor modulator (SERM), which indicated in animals that it prevented an increase in bone turnover and increased bone mineral density and mass. Further data from research on glucocorticoid receptor-dependent nonsteroidal anti-inflammatory agents and SERM development also will be presented.
¿ Medgenics Inc., of Misgav, Israel, completed a Series A financing of $7 million that included Alta Partners, of San Francisco; Koor Corporate Venture Capital, of Israel; and Alta Berkeley Venture Partners, of the UK. The funding is intended to develop the company¿s technology. Medgenics focuses on developing cost-efficient and patient-friendly treatments for disease using genetically engineered tissue to produce therapeutic proteins in the body.
¿ Oxford GlycoSciences plc, of Oxford, UK, and NeoGenesis Inc., of Cambridge, Mass., entered an alliance to accelerate OGS¿s small-molecule discovery and development against protein targets derived from its high-throughput proteomics platform. The agreement calls for OGS to provide potential protein targets and NeoGenesis to apply its high-throughput integrated technologies for chemistry, screening and computational biology to search for leads. OGS will provide NeoGenesis research funding, milestone payments and royalties on resultant products and will fund commercialization in addition to making an equity investment in NeoGenesis.
¿ RheoGene LLC, of Charlottesville, Va., was granted an exclusive license to Stanford University¿s newly issued U.S. Patent No. 6,245,531, covering genes that encode insect-based ecdysone receptors and methods for regulating gene expression in host cells. Financial terms were not disclosed.
¿ Ribozyme Pharmaceuticals Inc., of Boulder, Colo., and Chiron Corp., of Emeryville, Calif., initiated treatment of the first patient in their Phase II trial evaluating Ribozyme¿s antiangiogenic, Angiozyme, in patients with metastatic colorectal cancer. The 75-patient study of the candidate in combination with standard therapy is the second Phase II trial evaluating Angiomax in metastatic solid tumors.
¿ Sepracor Inc., of Marlborough, Mass., initiated a 12-week, Phase III study of (S)-oxybutynin in a sustained-release formulation for treatment of overactive bladder. The 850-patient study follows a pharmacokinetic and pharmacodynamic analysis of the therapy that was completed earlier this year.
¿ Sterix Ltd., of Oxford, UK, raised #8 million (US$11.1 million) through a private financing. The funding will be used to expand existing research and development programs and to take Oncomate, the company¿s steroid sulphatase inhibitor, into clinical development for treatment of breast cancer. Sterix focuses on the design and discovery of novel steroid derivatives and small-molecule drugs that modulate steroid metabolism.
¿ ViaCell Inc., of Boston, said a study published in the June 4, 2001, issue of The New England Journal of Medicine demonstrates that umbilical cord blood from unrelated donors is a feasible alternative source of hematopoietic stem cells for use in adults to treat diseases, including hematologic cancer. Data from the study demonstrated that 90 percent of patients undergoing umbilical cord blood stem cell transplantation achieved engraftment of HLA-mismatched donor cells and reconstitution of their hematopoietic systems.
¿ Zonagen Inc., of The Woodlands, Texas, said results from a Phase II study of its combination penile injection product, ERxin, indicated that treatment with a bimix of phentolamine and prostaglandin or a trimix containing phentolamine, papavarine and prostaglandin produced erections sufficient for vaginal penetration in 43 percent of test subjects at the lowest dose and 51 percent at the highest dose. The study results were presented at the International Congress of Andrology in Montreal.