Alkermes Inc., of Cambridge, Mass., and Eli Lilly and Co., of Indianapolis, presented detailed results from a Phase II trial of inhaled insulin in people with Type I diabetes at the 41st annual meeting of the European Association for the Study of Diabetes in Athens, Greece. Data showed that patients using the Lilly/Alkermes inhaled insulin system achieved blood sugar levels similar to patients treated with injected insulin. Also, 80 percent of patients in the study preferred the inhaled insulin system at mealtime over injected insulin, they said.
Ambion Inc., of Austin, Texas, and Rosetta Genomics Ltd., of Tenafly, N.J., entered a licensing agreement that will provide Ambion access to microRNA sequences discovered by Rosetta, and allow Ambion to adapt its microRNA platforms to detect, quantify and functionally characterize those sequences. The resulting products are expected to facilitate basic and applied microRNA research initiatives. Financial terms were not disclosed.
Biomira Inc., of Edmonton, Alberta, engaged PRA International, of Reston, Va., to help Biomira and Merck KGaA, of Darmstadt, Germany, with the planned Phase III trial of BLP25 liposome vaccine to treat non-small-cell lung cancer. The study should start the end of this year, and its trial design is being discussed with the FDA.
Cytori Therapeutics Inc., of San Diego, said preclinical results showed there are therapeutic opportunities for adult stem and regenerative cells derived from fat tissue in the treatment of cardiac injury following a heart attack. Cytori is developing its proprietary Celution system to isolate and concentrate a patient's own stem cells in about an hour, improving the speed in which personalized cell-based therapies can be delivered to patients.
DOV Pharmaceutical Inc., of Hackensack, N.J., said bicifadine, its non-narcotic and non-NSAID analgesic, provided statistically and clinically significant analgesic effect at 400 mg administered three times daily. The trial is the first of four pivotal Phase III trials required for submission of a New Drug Application to the FDA. The results are consistent with the safety and efficacy findings from two other double-blind, placebo-controlled studies in patients with moderate to severe pain following dental surgery.
Focus Diagnostics Inc., of Herndon, Va., entered a license agreement with Primagen Holding BV, of Amsterdam, the Netherlands, to develop PCR detection for human coronavirus NL63, a newly identified virus related to SARS and other coronaviruses. Financial terms were not disclosed.
Hybridon Inc., of Cambridge, Mass., changed its name to Idera Pharmaceuticals Inc. Its shares will trade on the American Stock Exchange under the symbol "IDP." The name change reflects the company's progress in developing targeted immune therapies based on Toll-like receptors, it said. The company's immune system receptors recognize elements of pathogens such as bacteria and trigger a defensive immune response.
Intradigm Corp., of Rockville, Md., published its positive results showing evidence of prophylactic and therapeutic effects of siRNA agents in Rhesus monkeys to treat SARS in the September issue of Nature Medicine. Intradigm's study revealed that siRNA inhibitors are active in vivo using a mouse model system and subsequently in a rhesus macaque SARS disease model using a clinically viable delivery by intranasal administration. The study was conducted in collaboration with Chinese academic and biotech groups.
Introgen Therapeutics Inc., of Austin, Texas, said updated interim results from an ongoing Phase II trial of INGN 225 in patients with advanced small-cell lung cancer show that the vaccine was well tolerated and appeared to sensitize lung tumors to additional chemotherapy, with 62 percent of patients who received second-line chemotherapy exhibiting objective responses. INGN 225 is a personalized vaccine that uses the p53 tumor suppressor gene to stimulate a patient's immune system.
Ipsogen SAS, of Marseille, France, and Genaissance Pharmaceuticals Inc., said they have signed agreements with two global pharmaceutical companies to focus on identifying biomarkers that might drive the response to anticancer drugs. Ipsogen will collect samples from clinical trials and will perform sample processing and pathology analysis, while Genaissance will perform genotyping and data analysis.
Isis Pharmaceuticals Inc., of Carlsbad, Calif., expects to receive initial payments of nearly $4 million from Alnylam Pharmaceuticals Inc., of Cambridge, Mass., as a result of Alnylam's alliance with Novartis AG, of Basel, Switzerland, to develop RNA interference therapeutics. Isis is entitled to a portion of the up-front payments and equity investment. It also has the potential to earn additional revenue in the form of milestone and royalty payments on drugs that use the Isis technology licensed to Alnylam in 2004. (See BioWorld Today, Sept. 8, 2005.)
Kosan Biosciences Inc., of Montreal, presented preclinical data at the World Congress of Gastroenterology 2005 supporting the selection of KOS-2187 as a clinical candidate to treat gastrointestinal motility disorders such as gastroparesis and gastroesophageal reflux disease. KOS-2187 is a novel erythromycin-based motilin agonist that appears to address the serious limitations of first-generation erythromycin analogues. Kosan started studies to support the entry of the compound into clinical trials in the second half of 2006.
Medarex Inc., of Princeton, N.J., licensed the use of its UltiMAb Human Antibody Development System to ImClone Systems Inc., of New York, to develop drug candidates for use in oncology. Medarex would receive license fees, milestone payments from any products that ImClone develops and royalties on commercial sales of such products.
New River Pharmaceuticals Inc., of Radford, Va., said results from a study of NRP290, a hydrocodone derivative for the treatment of pain, indicated that a single dose showed comparable bioavailability compared to hydrocodone bitartrate and acetaminophen tablets in fasted-state healthy adult volunteers, with an absence of intact NRP290 conjugates in the bloodstream.
Novamex USA Ltd., of Ville Saint Laurent, Quebec, signed a three-year agreement with MagnaCarta Capital Markets, of Montreal, for assistance in raising funds, establishing an investor relations program and planning for corporate acquisitions. Novamex works rapid diagnostic tests using immunodetection, specifically for agri-food and veterinary applications, based on the use of monoclonal antibodies.
NuGEN Technologies Inc., of San Carlos, Calif., which develops nucleic acid amplification and labeling systems, said that Elizabeth Hutt was appointed CEO effective Nov. 1. NuGEN's current acting CEO, Elizabeth Davila, will remain a member of the board. Hutt was previously NuGEN's vice president of commercial operations.
Onyx Pharmaceuticals Inc., of Emeryville, Calif., and Bayer Pharmaceuticals Corp., of West Haven, Conn., submitted a marketing authorization application to the European Medicines Agency for approval to market sorafenib to treat advanced renal-cell carcinoma. The companies plan to start a single-arm Phase III trial of sorafenib in the European Union for patients with advanced kidney cancer that have been previously treated. The trial will take place at sites in 11 European Union countries and should begin this fall. In July, Onyx and Bayer submitted a new drug application with the FDA for sorafenib for patients with advanced renal-cell carcinoma.
Peptech Ltd., of Sydney, Australia, signed an agreement with a biopharmaceuticals manufacturer to manufacture its anti-TNF domain antibody-based therapeutic for use in humans and in non-human preclinical studies. Peptech previously reported results of a preclinical study, in which the compound recorded potency levels about three times higher than a leading blockbuster anti-TNF drug against rheumatoid arthritis.
Progenitor Cell Therapy LLC, of Hackensack, N.J., said that its cGMP facility in Mountain View, Calif., will serve as the manufacturing site for the premier product of Cellerant Therapeutics Inc., of Palo Alto, Calif. That product is CLT-001, a highly purified hematopoietic stem cell product for the treatment of genetic blood disorders.
Proneuron Biotechnologies Inc., of Los Angeles, said results of the first ProCord study showed that the immune cell therapy, comprised of autologous incubated macrophages, was found to be safe and well tolerated, and preliminary efficacy results also were generated. Of the eight acute spinal cord injury patients, enrolled within 14 days of their injuries, three of those recovered some feeling and went on to recover limited movements below the level of injury. Those data were published in the September 2005 issue of the Journal of Neurosurgery: Spine. The company is conducting a Phase I extension study and a Phase Ib study, which also have added to ProCord's safety profile.
Protein Design Labs Inc., of Fremont, Calif., closed its previously announced collaboration with Cambridge, Mass.-based Biogen Idec Inc. for the joint development, manufacture and commercialization of three Phase II antibody products. The agreement includes daclizumab in multiple sclerosis and other indications, and M200 (volociximab) and HuZAF (fontolizumab) in all indications. At the closing, PDL received an up-front payment of $40 million, and Biogen purchased common stock fro PDL for aggregate proceeds of about $100 million. PDL also stands to receive potential milestone payments of up to $660 million. (See BioWorld Today, Aug. 4, 2005.)
Vical Inc., of San Diego, plans to develop and evaluate electroporation-enhanced delivery of therapeutic and preventive DNA vaccines against HIV under a cooperative research and development agreement with the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases. Vical has the option to secure exclusive commercialization rights to technology developed under the CRADA. In other news, Vical agreed to grant Merck & Co. Inc., of Whitehouse Station, N.J., renewable options for rights to use Vical's non-viral gene delivery technology for additional cancer targets. Vical has obtained nonexclusive, sublicenseable rights to use the technology for vaccines against HIV. Merck also has a fixed-term option to exclusively sublicense from Vical electroporation-enhanced delivery technology for use with HIV vaccines.
Vicuron Pharmaceuticals Inc., of King of Prussia, Pa., said the waiting period has expired, and it expects its merger with New York-based Pfizer Inc. will close Sept. 14. Pfizer offered to buy Vicuron in June for about $1.9 billion, or $29.10 per share, and, in exchange, adds to its pipeline two products under FDA review: Vicuron's anidalufungin, a once-daily drug for fungal infections, and dalbavancin, a once-weekly treatment for Gram-positive infections. (See BioWorld Today, June 17, 2005.)
Zelos Therapeutics Inc., of Waltham, Mass., said its CEO, Robert DuFresne, stepped down. DuFresne had served as CEO and as a member of the company's board since March 2003. Zelos focuses on developing next-generation parathyroid hormone research programs, including the PTH analog, Ostabolin-C, in Phase II trials to treat osteoporosis, and a PTH agonist for the topical treatment of psoriasis.
Zonagen Inc., of The Woodlands, Texas, awarded contracts to Houston-based Pharma-Olam International Ltd., a contract research organization, for planned U.S. studies of Proellex and Androxal. The company intends to conduct a 150-patient Phase II trial of Proellex to treat uterine fibroids, and a 210-patient Phase III trial of Androxal to treat testosterone deficiency. If investigational new drug application submissions are acceptable to the FDA, dosing should begin before the end of 2005.