Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said it will to delay the development of ALN-VEG01, its vascular endothelial growth factor (VEGF)-targeting drug to treat age-related macular degeneration. President and CEO John Maraganore attributed the decision to an "increasingly competitive landscape for VEGF-targeting AMD therapeutics on the market and in late-stage human trials." Instead, the company plans to allocate its resources to advancing ALN-RSV01, an RNAi therapeutic candidate for treating respiratory syncytial virus infection. Alnylam now plans to file an investigational new drug application for ALN-RSV01 by the end of the year, rather than during the first half of 2006, as originally scheduled.
Avantogen Ltd., of Sydney, Australia, formerly Australian Cancer Technology, and Innovate Oncology, of San Diego, said encouraging clinical results from a study of RP101 in patients with pancreatic cancer were presented at the 2nd International Conference on Tumor Progression and Therapeutic Resistance in Burlington, Mass. Avantogen and Innovate have jointly licensed RP101 from RESprotect GmbH, of Dresden, Germany, and intend to sponsor clinical trials in the U.S. in early 2006. Results presented showed that 10 of 13 patients survived at least one year following treatment. Median survival was 447 days.
AVI BioPharma Inc., of Portland, Ore., initiated patient enrollment in Germany for the company's Appraisal Phase II study. The trial is designed to evaluate AVI's Resten-MP in the prevention of cardiovascular restenosis when delivered intravenously in conjunction with the placement of one or more bare-metal stents. Resten-MP is AVI-4126 delivered via intravenous injection using AVI's microparticle delivery technology.
Celera Genomics Group, of Rockville, Md., initiated Phase I testing for cathepsin S inhibitor CRA-028129 for the treatment of psoriasis. In the Phase I trial, healthy volunteers will be randomized to receive orally administered CRA-028129 or placebo. About 70 subjects will be enrolled in the trial.
Cytokinetics Inc., of South San Francisco, presented a poster on CK-1827452, a small-molecule activator of cardiac myosin, Tuesday at the 2005 Annual Heart Failure Society of America Meeting. CK-1827452 is the first drug candidate produced from Cytokinetics' cardiac myosin activator program and is in a Phase I trial.
Geron Corp., of Menlo Park, Calif., said underwriters of its public offering exercised their overallotment option in full to purchase 900,000 additional shares, resulting in an additional $8.1 million to the company. That adds to the $72 million raised through the sale of 8 million shares at $9 each, including 2 million shares sold to Whitehouse Station, N.J.-based Merck & Co. Inc., relating to a telomerase vaccine collaboration signed in July. (See BioWorld Today, Sept. 19, 2005.)
GTC Biotherapeutics Inc., of Framingham, Mass., will be producing MM-093, a recombinant version of human alpha-fetoprotein, for Cambridge, Mass.-based Merrimack Pharmaceuticals Inc. Merrimack is conducting a Phase II study of MM-093 in patients with rheumatoid arthritis. No further details of the agreement were disclosed.
IBEX Technologies Inc., of Montreal, signed two new distribution agreements for its glycobiology enzymes. Beginning this quarter, Associates of Cape Cod Inc., a subsidiary of Tokyo-based Seikagaku Corp., and Prozyme Inc., of San Leandro, Calif., will begin marketing and distributing the IBEX enzymes to customers worldwide.
Illumina Inc., of San Diego, has signed an agreement with the Max-Planck Institute of Psychiatry in Munich, Germany, to supply Illumina's Sentrix BeadChips and Infinium assay reagents for a large-scale genotyping study. The study will be performed by MPI's Center for Applied GenoTyping to identify genetic variations that predispose people to specific disorders and to further determine the impact of genetic variants on disease pathogensis.
Intranasal Technology Inc., of Lexington, Ky., changed its name to Intranasal Therapeutics Inc. to reflect its new business strategy to develop and market nasally delivered products that address unmet medical needs. The company intends to focus on commercializing certain products with its own sales force, while working with marketing partners on other products, including some in its development pipeline.
Isis Pharmaceuticals Inc., of Carlsbad, Calif., initiated Phase II development of ISIS 301012 for lowering of high cholesterol. ISIS 301012 is a second-generation antisense drug that targets apoB-100, the protein component of low-density lipoprotein cholesterol. It is a double-blinded, placebo-controlled study, and patients will be followed for six months.
MerLion Pharmaceuticals Pte. Ltd., of Singapore, and Cancer Research Technology Ltd., of London, entered a large-scale screening program to identify new cancer drug candidates derived from natural product chemistry. MerLion will screen its natural compound collection against high-throughput screens developed by scientists at CRT in order to isolate new therapeutic compounds against validated cancer targets. The results of the collaboration will be jointly owned.
Mesoblast Ltd., of Melbourne, Australia, enlisted Cambrex Corporation Inc., of East Rutherford, N.J., for large-scale production of its proprietary adult stem cells. The cells are being evaluated for the treatment of a range of orthopedic and cardiovascular conditions and will be used in U.S.-based clinical trials.
Monsanto Co., of St. Louis, and Targeted Growth Inc., of Seattle, agreed to develop and commercialize a yield enhancement gene developed by TGI. Terms include exclusive licensing rights to one of TGI's gene enhancing technologies in applicable Monsanto crops, in return for up-front, milestone and royalty payments. In other news, Monsanto also entered a licensing agreement for rights to a nitrogen use efficiency technology in canola developed by Arcadia Biosciences Inc., of Davis, Calif. Monsanto will pay Arcadia an up-front fee, along with milestones and royalties.
Nabi Biopharmaceuticals, of Rockville, Md., initiated a repeated dosing study designed to evaluate the ability of StaphVAX (Staphylococcus aureus Polysaccharide Conjugate Vaccine) to provide continuous protection in patient populations who are at high chronic risk for S. aureus infections. The trial will evaluate StaphVAX in end-stage renal disease patients on dialysis who are at high risk of contracting an S. aureus infection during their invasive and long-term treatment.
Nastech Pharmaceutical Co. Inc., of Bothell, Wash., said the International Journal of Obesity published preclinical results relating to the administration of PYY to treat obesity. The major finding is that the treatment group receiving 205 ug/kg of PYY intravenously once daily over 14 days had lower average weight, compared to the control group. Researchers also observed a trend in reduced food consumption in rabbits provided with fixed daily food allotment.
Procyon Biopharma Inc., of Montreal, said results of research describing the mechanism of action of PCK3145, its therapeutic peptide in clinical trials for the treatment of advanced prostate cancer, are set to be published in three scientific journals and one prostate cancer journal. Data show that the drug acts as a signal transduction inhibitor with anti-angiogenic and antimetastatic effects. Procyon has filed an investigational new drug application for PCK3145, and has an ongoing pilot study expected to be a lead-in to a North American Phase II trial.
Sequenom Inc., of San Diego, received a letter from the Nasdaq staff on Sept. 16 indicating that the company does not comply with the $1 minimum bid price requirement for continued listing set forth in the Marketplace Rules. Sequenom will have 180 days, or until March 15, to regain compliance.
SIGA Technologies Inc., of New York, entered an agreement with St. Louis University for the continued development of SIGA's oral smallpox drug, SIGA-246. The agreement is funded through the National Institutes of Health. SIGA will receive about $1 million to support specific aspects of the preclinical development of SIGA-246. SIGA will receive the revenue over the next six months.
Somaxon Pharmaceuticals Inc., of San Diego, began enrolling patients in its second Phase III study of Silenor (doxepin hydrocholoride) for the treatment of insomnia. That trial will evaluate the drug's safety and efficacy over a three-month period in elderly patients diagnosed with primary chronic insomnia, with the primary endpoint of wake after sleep onset. Somaxon initiated the Phase III program in June after completing a $65 million Series C financing. (See BioWorld Today, June 10, 2005.)
Speedel Holding Ltd., of Basel, Switzerland, said Novartis AG, also of Basel, released positive Phase III results of SPP100 (Aliskiren) as a monotherapy and in co-administration with the diuretic hydrochlorothiazide in treating hypertension. Novartis said it is on track for its first regulatory submission of SPP100 in the U.S. in early 2006, and in the European Union in the fourth quarter of 2006. The latest results confirmed previous findings from clinical studies conducted by Speedel, which in-licensed the compound from Novartis and developed SPP100 through Phase I and II before Novartis exercised a license-back option in 2002.
U.S. BioDefense Inc., of City of Industry, Calif., received its first stem cell line as a part of an agreement with the University of British Columbia. The company will begin evaluation of the neural crest stem cell line before beginning production of a commercial line that will be available for research use by universities and other biotech companies. U.S. BioDefense also will evaluate the use of this line for human transplantation in collaboration with the FDA. Further development of the cell line could lead to a treatment for brain neurodegeneration and spinal cord repair.
VION Pharmaceuticals Inc., of New Haven, Conn., initiated a Phase II trial of Cloretazine in small-cell lung cancer. The objectives of the study are to determine the response rate and toxicity of Cloretazine in patients with locally advanced or metastatic small-cell lung cancer who have either not responded to or relapsed following initial treatment for the disease.
Vyteris Holdings Inc., of Fair Lawn, N.J., said data from a Phase I study of Actyve transdermal drug technology showed that the product could be used to provide controlled delivery of zolmitriptan in humans. The study compared zolmitriptan pharmacokinetics following transdermal iontophoretic delivery and oral administration. Zolmitriptan is the active ingredient in Zomig, a treatment for migraine.
XOMA Ltd., of Berkeley, Calif., will collaborate with Cubist Pharmaceuticals Inc. to develop new processes to manufacture the two-antibody biologic HepeX-B. The processes are needed to produce enough quantities of the biologic to conduct Phase III trials. XOMA will begin work on the project immediately and will negotiate a longer-term agreement with the Lexington, Mass.-based Cubist. HepeX-B has orphan drug status in the U.S. and the European Union.
Zimmer Holdings Inc., of Warsaw, Ind., acquired worldwide, exclusive distribution rights for genetically engineered xenogeneic tissues for regenerative therapies from Revivicor Inc., of Blacksburg, Va., which has an advanced transgenic technology platform for the production of tissues, cells and whole organs for therapeutic applications. Zimmer initially plans to develop the technologies for orthopedic applications.