AnorMed Inc., of Vancouver, British Columbia, initiated two Phase II trials of AMD3100 for stem cell transplantation in cancer patients. The first study will evaluate the compound as a single agent in multiple myeloma patients undergoing a stem cell transplant. The second study will evaluate it in combination with the standard mobilization regimen in patients with Hodgkin's disease undergoing a transplant. Data have shown that AMD3100 can increase the number of stem cells available for transplantation when used in combination with standard regimens. AMD3100 is an inhibitor of the CXCR4 chemokine receptor.
Arena Pharmaceuticals Inc., of San Diego, initiated dosing in a Phase I trial for APD125 to treat insomnia. The single-dose protocol should be completed in the second quarter. The study will evaluate the safety, tolerability and pharmacokinetic profile of APD125 in healthy volunteers and will be conducted in France. APD125 is an antagonist of the 5-HT2A serotonin receptor.
BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., watched its stock drop 16.6 percent on Wednesday, one day before an FDA committee will discuss the new drug application for Cincinnati-based Procter & Gamble Co.'s testosterone patch, Intrinsa, to treat hypoactive sexual desire disorder in surgically menopausal women receiving concomitant estrogen therapy. BioSante is developing a similar product, a testosterone gel called LibiGel. Data presented last month showed that LibiGel 150 mcg per day significantly increased the number of satisfying sexual events by 238 percent vs. baseline and placebo. The FDA, however, has expressed concerned about the long-term safety of testosterone therapies. BioSante's stock (AMEX:BPA) dropped $1.67, to close at $8.40.
Centocor Inc., of Malvern, Pa., said the FDA accepted its filing of a supplemental biologics license application for Remicade (infliximab) to treat psoriatic arthritis in patients with active disease. The filing is based on the results of two double-blind, placebo-controlled trials that showed more than half of the patients in the Remicade treatment group achieved significant improvements in signs and symptoms at week 14. Remicade is an anti-tumor necrosis factor-alpha therapy approved to treat rheumatoid arthritis and Crohn's disease in North America, the European Union and Japan, and for ankylosing spondylitis in the European Union.
Cephalon Inc., of West Chester, Pa., filed a supplemental new drug application with the FDA requesting approval of a sugar-free formulation of Actiq (oral transmucosal fenanyl citrate). Actiq is approved for the management of breakthrough cancer pain in patients with malignancies who already are receiving and are tolerant to opioid therapy for underlying persistent cancer pain. If approved, the sugar-free formulation would be marketed for the same indication. Cephalon expects final FDA approval to come by the end of the second quarter.
Ciphergen Biosystems Inc., of Fremont, Calif., closed the previously announced sale of its BioSepra process chromatography business to Pall Corp., of East Hills, N.Y., for about $32 million, net of cash and debt. Also, the companies entered a collaboration for process proteomics, based on the combination of Ciphergen's ProteinChip technology and BioSepra chromatography products. Ciphergen also will retain certain limited rights to access BioSepra chromatography sorbent technology for manufacture, use and sale in the research and diagnostic markets.
CytRx Corp., of Los Angeles, said iroxanadine was effective in treating cardiovascular disease in a mouse model of atherosclerosis. The experiments demonstrated that iroxanadine reduced plaque formation and arterial thickening in mice. The experiments were performed in an ApoE mouse strain, which was genetically engineered to have deficient cholesterol metabolism. Iroxanadine is believed to work through the activation of certain molecular chaperone proteins that repair normal damage in cells.
Emisphere Technologies Inc., of Tarrytown, N.Y., received $10 million from Basel, Switzerland-based Novartis Pharma AG in exchange for a convertible note. The investment is part of a new agreement between the companies for the development and commercialization of an oral form of parathyroid hormone (PTH) by Novartis using Emisphere's eligen delivery technology. Emisphere is in litigation with Indianapolis-based Eli Lilly amd Co. concerning the termination of the existing oral PTH collaboration. If it is terminated, and Novartis exercises its option to the license, Emisphere would be eligible for milestone payments totaling up to $30 million, plus royalties on sales. Emisphere's stock (NASDAQ:EMIS) rose 42 cents Wednesday, or 13.7 percent, to close at $3.49.
Evolutionary Genomics, of Aurora, Colo., said its researchers identified several adapted chimpanzee genes that might play a role in combating AIDS. The article is published in the Feb. 7, 2005, issue of the Journal of Theoretical Biology.
Genmab A/S, of Copenhagen, Denmark, reported encouraging efficacy data from a Phase I/II trial of HuMax-EGFr in head and neck cancer. Using a scan known as FDG-PET, which visualizes tumor metabolism, six of 15 patients showed partial metabolic response and three patients showed stable metabolic disease. They received doses of 2, 4 or 8 mg/kg.
GenoMed Inc., of St. Louis, formed a collaboration with British and Japanese experts to test its patent-pending treatment for prion diseases, or transmissible spongiform encephalopathies. Nikolai Rainov, of the Walton Centre for Neurology and Neurosurgery NHS Trust and the University of Liverpool, will participate in testing the approach in animal models. Katsumi Doh-ura's research group at Tohoku University in Sendai, Japan, will carry out animal experiments.
Innovive Pharmaceuticals Inc., of New York, named Steven Kelly president and CEO. The company was established this year to acquire, develop and commercialize therapeutics in oncology and hematology. Kelly headed the oncology marketing group for Sanofi-Synthelabo's U.S. division, where he led the launch of the colorectal cancer drug Eloxatin. He also worked at Idec Pharmaceuticals Inc. and Amgen Inc.
Invitrogen Corp., of Carlsbad, Calif., licensed rights to specific fields of use for more than 30 patents in protein microarray development from Zyomyx Inc., of Hayward, Calif. Invitrogen has exclusive rights to intellectual property covering development processes for those microarrays that use certain detection modalities and contain more than 200 protein-based analytes. Financial details were not disclosed.
Isotechnika Inc., of Edmonton, Alberta, said it received the go-ahead from Health Canada to begin a Phase III trial of ISA247. The 24-week trial will be held at 33 centers across Canada and will involve 400 subjects with severe psoriasis. Subjects will be divided into four groups of 100 patients, with each group receiving either a high dose of 0.4 mg/kg twice daily, the anticipated therapeutic dose of 0.3 mg/kg twice daily, a low dose of 0.2 mg/kg twice daily or placebo. Success will be measured by the proportion of patients that achieve a 75 percent reduction in the Psoriasis Area and Severity Index.
Maxim Pharmaceuticals Inc., of San Diego, said two manuscripts were published in the current Journal of Molecular Cancer Therapeutics describing Maxim's MX116407 cancer drug as part of a new class of microtubule inhibitors with vascular-targeting activity. The manuscripts describe MX116407 as a caspase activator with antitumor activity in preclinical in vitro and in vivo studies. The drug appeared effective in mouse tumor models, producing tumor necrosis at doses that correspond to only 25 percent of the maximum tolerated dose. Also, in combination treatment, it enhanced the antitumor activity of cisplatin, resulting in tumor-free animals, Maxim said.
Medical Discoveries Inc., of Twin Falls, Idaho, filed an investigational new drug application with the FDA for a Phase I trial of the company's MDI-P in late-term cystic fibrosis adults. MDI-P will be tested as an adjunct therapy to inhaled Tobramycin, an antibiotic used to treat bacterial infections. The company said most late-term adult CF patients are dependent on the inhaled form of Tobramycin, manufactured by Chiron Corp., of Emeryville, Calif.
The Michael J. Fox Foundation for Parkinson's Research in New York created a drug discovery and development program to address obstacles that impede progress in bringing new Parkinson's therapies to market. The first initiative will provide $1.5 million in funding to validate drug targets for Parkinson's research.
Millennium Pharmaceuticals Inc., of Cambridge, Mass., said the FDA accepted for review the company's supplemental new drug application and granted priority-review designation for Velcade for the treatment of patients with multiple myeloma who have received at least one prior therapy. The submission was based on data from the Phase III APEX study that compared Velcade to a traditional myeloma therapy, high-dose dexamethasone, which demonstrated a statistically significant survival in patients receiving Velcade. Velcade is approved for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy.
Morphotek Inc., of Exton, Pa., entered a collaboration and license agreement with Novo Nordisk A/S, of Bagsvaerd, Denmark, for the use of Morphotek's Morphodoma technology to develop high-affinity antibodies and high-titer antibody-producing mammalian cells for scalable manufacturing. It is the second agreement between the companies. Under the nonexclusive, multiyear agreement, Morphotek will receive an up-front payment and funding to support research and development efforts to optimize up to four independent products. Morphotek also will receive a licensing fee and milestone payments upon the achievement of program goals and the advancement of the products through clinical development. Novo will conduct the preclinical and clinical development and subsequent commercialization of all products.
Nanogen Inc., of San Diego, agreed to provide $300,000 of funding over a two-year period to support the nanotechnology research of Michael Heller, a professor in the department of bioengineering at Jacobs School of Engineering, University of California at San Diego and co-founder of Nanogen. Heller's research will focus on exploring further use of electric field-based technology for nanofabrication and assembly of nanostructures, as well as the integration of nanostructures with other devices.
Newron Pharmaceuticals SpA, of Milan, Italy, raised European funding from the Cooperative Research Programme to innovate a drug-screening technology by the company and a consortium of small to medium enterprises and academic groups. Newron will coordinate the two-year research project called ION, the scope of which is to develop a system for high-throughput screening of molecules for ion channel targets related to neurological and psychiatric disorders.
Prometheus Laboratories Inc., of San Diego, entered an agreement with AstraZeneca plc, of London, for the exclusive marketing, sales and distribution of Entocort EC (budesonide) capsules in the U.S. beginning Jan. 5. Entocort EC is approved for mild to moderate active Crohn's disease involving the ileum and/or the ascending colon, the company said. It is anticipated that net sales of Entocort EC will be about $30 million for AstraZeneca in 2004.
Purely Proteins Ltd., of Cambridge, UK, received a second round of venture funding of $3.6 million. Led by Avlar BioVentures, the round also included VCT2 plc and Bioscience VCT plc. Purely Proteins was founded by former Pfizer Inc. scientists in association with scientists from Cambridge University. The company purifies suites of human proteins as drug targets and biotherapeutics. Purely Proteins also offers ligand screening services. Separately, the company initiated a research collaboration focused on biomedical products with Asahi-Kasei Corp., of Tokyo. The project will develop methods for purifying proteins using the ligand discovery systems developed at Purely Proteins.
Structural GenomiX Inc., of San Diego, and Cystic Fibrosis Foundation Therapeutics Inc., of Bethesda, Md., published findings on cystic fibrosis in the Nov. 4, 2004, advance online publication of the Journal of Biological Chemistry. The findings were made through the investigation of the 3-dimensional crystal structure of a region of the human cystic fibrosis transmembrane conductance regulator protein implicated in the onset of cystic fibrosis, known as nucleotide binding domain 1.
Tissera Inc., of Herzlia, Israel, said its sponsored research team at the Weizmann Institute of Science defined a specific gestational time window for harvesting porcine fetal pancreatic tissue for transplantation purposes. The window of opportunity might explain, in part, previous failures in trials of transplantation of porcine fetal pancreatic tissue into diabetic patients. The results indicate that the growth potential of fetal pancreatic tissue obtained at an appropriate gestational time is superior to that exhibited by pancreatic tissues used in previous studies, the company said.
TransForm Pharmaceuticals Inc., of Lexington, Mass., received an initial milestone payment in connection with having concluded a series of crystallization studies under its relationship with AstraZeneca plc, of London. TransForm receives research funding and payments for meeting success criteria in connection with performing crystallization studies on specific AstraZeneca compounds. Additional financial terms were not disclosed.
XDx Inc., of South San Francisco, completed a $20 million Series D private equity financing. The Sprout Group led the investment, with participation from new investors JP Morgan's Bay Area Equity Fund, Integral Capital Partners and Burrill & Co., as well as existing investors Kleiner Perkins Caufield & Byers and TPG Ventures. XDx will launch AlloMap molecular-expression testing with the funding, a blood sample-based test developed to manage the immunologic questions posed by cardiac transplant patients. In connection with the financing, Vijay Lathi, a partner at Sprout Group, joined XDx's board.
Xencor Inc., of Monrovia, Calif., formed a license and collaboration agreement with South San Francisco-based Genentech Inc. to create next-generation therapeutic antibodies for cancer and autoimmune diseases. Genentech gains an exclusive, worldwide license to use Xencor's XmAb technology to develop and commercialize products directed against two clinically and commercially validated antibody targets, CD20 and Her2, and a third undisclosed antigen. Xencor will receive an up-front fee of $5 million and annual licensing fees, as well as milestone payments for each collaboration target and royalties on sales.