Aerogen Inc., of Mountain View, Calif., entered a cooperative research and development agreement with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) relating to inhaled vaccines targeted to counter certain effects of bioterrorism. Aerogen is providing the USAMRIID with modifications of Aerogen’s Aeroneb professional nebulizer system. USAMRIID will perform animal research studies using the product with vaccines against biological warfare agents to develop improved immunization for military personnel.
Alfacell Corp., of Bloomfield, N.J., reported preclinical results demonstrating that Onconase (ranpirnase) exerts its antiviral activity at two stages in the HIV-1 life cycle. The findings were published in the April 26, 2002, issue of the Journal of Biological Chemistry. Onconase exerts its antiviral activity at the viral replication initiation stage by degrading the tRNA (Lys3) species, and also by selectively degrading the spectrum of HIV-1 RNA species without killing the viral-infected cells.
Antigenics Inc., of New York, enrolled the first patient in a pivotal Phase III trial of its personalized cancer vaccine, Oncophage (HSPPC-96), for the treatment of metastatic melanoma. The study is expected to involve more than 200 patients in the U.S. and Europe and will compare the safety and efficacy of Oncophage treatment with the current standard of care. Already undergoing Phase III evaluation for treatment of nonmetastatic renal cell carcinoma, Oncophage received fast-track designation from the FDA for the treatment of kidney cancer and advanced melanoma.
Astralis Ltd., of Fairfield, N.J., received a $2.5 million payment from SkyePharma plc, of London. The payment represents the second installment of $10 million due under the December 2001 stock purchase agreement between the companies. Under the terms of the original equity agreement, SkyePharma is expected to make an equity investment in Astralis of up to $20 million in convertible preferred shares, giving SkyePharma 18 percent ownership of Astralis. SkyePharma made an initial investment of $10 million on Dec. 10, the effective date of the agreement, and two subsequent investments totaling $5 million.
Atlantic Technology Ventures Inc., of New York, received German regulatory approval to initiate a Phase II pilot trial evaluating the safety, efficacy and dosing of its CT-3 compound against chronic neuropathic pain. The study will be a randomized, double-blind, placebo-controlled, escalating-dose, crossover trial of CT-3 in 21 patients, and will be conducted at the University of Hannover Medical School in Hannover, Germany. Atlantic said it will begin enrolling patients immediately. Atlantic’s stock (OTCBB:ATLC) climbed 5 cents Thursday, or 20 percent, to close at 30 cents.
Avanir Pharmaceuticals Inc., of San Diego, said it received notification from the California Trade, Technology and Commerce Agency that a California Technology Investment Partnership grant has been funded. In 2001, the San Diego Regional Technology Alliance announced that Avanir was eligible to receive the award of $150,000 as a matching funds grant that could be used only in conjunction with a federally funded grant. Complementing the award is a $1 million Phase II Small Business Innovation Research grant from the National Institutes of Health, of Bethesda, Md., which Avanir received earlier this year. The funds will be used for defining and assessing the market for a genital herpes product using docosanol 10 percent cream, Avanir’s lead product that was approved by the FDA for the treatment of cold sores.
Biomira Inc., of Edmonton, Alberta, received final clearance from Canadian regulatory authorities for a $150 million shelf prospectus filed in specified Canadian jurisdictions. Biomira concurrently filed a shelf registration statement in the U.S. The prospectus will be effective for approximately 25 months. Biomira does not intend to offer securities under the shelf prospectus until a prospectus supplement has been filed. The actual amount of any securities to be issued, and their terms, would be determined at the time of sale.
CancerVax Corp., of Carlsbad, Calif., said the FDA asked it to provide certain information related to the production, characterization and testing of the company’s Canvaxin vaccine. CancerVax has placed a hold on the enrollment of new patients in its Phase III trial, although those receiving Canvaxin may continue to do so. The company said the hold is not related to any clinical practice or safety concerns. The company said its “immediate goal is to develop the manufacturing-related information requested by the FDA,” and added that the company is “committed to fully resuming patient enrollment . . . as soon as possible.”
Centocor Inc., of Malvern, Pa., said a study published in this week’s issue of The Lancet showed sustained use of infliximab (Centocor’s Remicade) could benefit sufferers of Crohn’s disease. In a 355-patient, international study, more than twice as many people given infliximab every two months were in remission after 30 weeks, compared to patients who received initial infliximab treatment followed by placebo. Patients given infliximab also were more likely to discontinue using steroids than those given placebo.
Cropsolution Inc., of Research Triangle Park, N.C., closed its initial financing round after raising $6.4 million. The round was led by the Aurora Funds, of Durham, N.C., with additional investments from ATP Capital, of New York; Research Triangle Ventures, of Raleigh, N.C.; Charlotte Angel Partners, also of Charlotte; the Atlantis Group, also of Durham; and other individuals. Cropsolution develops agrochemicals to protect crops from diseases, pests and weeds.
CuraGen Corp., of New Haven, Conn., and Abgenix Inc., of Fremont, Calif., developed highly specific, fully human monoclonal antibodies that precisely bind to PDGF D, a member of the platelet-derived growth factor family. The antibodies are specific to PDGF D, a growth factor that has proliferative activity on a variety of cells that express PDGF receptors, and do not bind to other members of the PDGF family. CuraGen demonstrated that PDGF D is associated with a number of diseases in the areas of oncology and inflammation. Those antibodies, as well as the role of PDGF D in oncology, are published in the May 1, 2002, issue of Cancer Research.
Emergent Technologies Inc., of Austin, Texas, said its newly formed company, Heparinex LLC, of Oklahoma City, licensed a method of biotechnology from the University of Oklahoma Health Sciences Center in Oklahoma City. The company will commercialize the technology, developed by Paul DeAngelis, an associate professor at the university, whose innovation in recombinant heparin production enables direct manufacture of heparin. It is the fourth company launched by Emergent in Oklahoma City since 1999.
Genaera Corp., of Plymouth Meeting, Pa., said a study was published in the current issue of Oncogene evaluating the potential of squalamine, its anti-angiogenic agent, in the treatment of ovarian cancer. The publication details data indicating that inhibition of the growth of human ovarian cancer xenografts was elicited by squalamine alone, and by combined treatment with cisplatin. Results show that squalamine is anti-angiogenic for human ovarian cancers and appears to enhance cytotoxic effects of cisplatin chemotherapy in tumors with or without overexpression of the HER-2 oncogene.
Immunex Corp., of Seattle, said Enbrel (etanercept) was the subject of a Spondylitis Association of America report showing that the drug can help ease symptoms of a type of arthritis known as ankylosing spondylitis, which primarily affects the spine. In the 40-patient, four-month study, 80 percent of patients in the etanercept group showed improvement in three of five measures: morning stiffness, spinal pain, joint swelling, functioning and patient assessment of disease activity. Comparatively, 30 percent in the placebo group showed such improvement. The results were published in the May 2, 2002, issue of The New England Journal of Medicine.
Immunicon Corp., of Huntingdon Valley, Pa., opened Immunicon Europe Inc., of Enschede, the Netherlands. Immunicon’s European operations will develop its CellTracks platform technology and serve as a base from which to conduct clinical research and development studies across Europe. Immunicon develops cell-based diagnostic and related products.
Inhale Therapeutic Systems Inc., of San Carlos, Calif., presented new data from Phase III studies conducted by Pfizer Inc., of New York, and Aventis Pharma AG, of Frankfurt, Germany, with the Exubera inhaled insulin product using Inhale’s inhaleable technology. The data, presented at the American Association of Clinical Endocrinologists’ 11th annual meeting and clinical congress, indicated, among other things, that Exubera might provide a treatment option for patients with Type I diabetes. The six-month study involved 335 patients with Type I diabetes between the ages of 12 and 65. The glycated hemoglobin, or HbA1c, decreased similarly in both groups. The percentage of patients achieving an HbA1c of less than 8 percent or less than 7 percent also was similar in both groups. Also, patients using Exubera showed significantly greater decreases in both fasting plasma glucose concentrations (a measurement taken before breakfast) and two-hour post-prandial glucose levels (a measurement taken after a meal) compared to patients who took only insulin injections.
Interleukin Genetics Inc., of Waltham, Mass., said it developed a map of the nine genes in the interleukin-1 gene family that code for proteins central to the human inflammatory response. The map combines information from the incomplete public database sequences with Interleukin’s sequence information to generate a reference sequence and map that encompass all the genes in the interleukin-1 cluster. Details of the map and a discussion of the researchers methods are published in the May 2002 issue of Genomics.
Ligand Pharmaceuticals Inc., of San Diego, said its once-daily pain product, Avinza (morphine sulfate extended-release capsules), reduced pain and improved overall quality of sleep in patients with chronic, moderate to severe osteoarthritis (OA) pain, compared to placebo, according to a Phase III study published in The Journal of Pain and Symptom Management. The article detailed a randomized four-week study evaluating the safety and efficacy of Avinza, MS Contin (MSC, morphine sulfate controlled-release), and placebo in 295 patients with chronic, moderate to severe OA pain. Avinza showed a 17 percent scale improvement and MSC twice daily showed an 18 percent improvement, both statistically significant reductions in pain from baseline compared to placebo (4 percent). Once-daily Avinza was approved by the FDA in March, and Ligand plans to launch the drug this quarter.
MedinetLondon, of London, was formed to assist and to maximize opportunities for development and commercialization of the intellectual property that arises within health care and, in particular, from the work of hospitals in London. MedinetLondon is expected to bridge the gap between those responsible for generating IP and those from the commercial sector who have the potential to transfer it into new products for health care.
Oncosis Inc., of San Diego, spun out Cyntellect, a company to adapt and commercialize the Laser-Enabled Analysis and Processing (LEAP) technology platform for the life sciences and drug discovery research markets. Cyntellect will focus on developing the technology for nonclinical uses, initially pursuing live cell analysis/ manipulation and high-content, high-throughput screening. Oncosis will continue to focus on the development and optimization of its Photosis technology platform for cellular therapy.
Ortec International Inc., of New York, reported at the 15th annual symposium on Advanced Wound Care that its studies on growth factor and cytokine production revealed that granulocyte macrophage-colony stimulating factor, a cytokine that plays a direct role in the acceleration of wound healing, is expressed by OrCel at a level at least 10 times greater than Apligraf. In addition, OrCel expresses twice the levels of vascular endothelial growth factor, which causes proliferation of vascular endothelial cells.
OSI Pharmaceuticals Inc., of Melville, N.Y., completed the initial stage of the ongoing Phase III trial of Tarceva (erlotinib HCl, OSI-774) in pancreatic cancer. The 800-patient, randomized, controlled trial is being conducted in collaboration with the National Cancer Institute of Canada Clinical Trials Group to assess Tarceva in combination with gemcitabine (Gemzar), the only approved front-line chemotherapy treatment for pancreatic cancer. Improvement in patient survival is the study’s primary endpoint.
Oxford GlycoSciences plc, of Oxford, UK, reported at the fifth European Working Group on Gaucher’s disease meeting in Prague, Czech Republic, data from its six-month OGT 918-004 study of Vevesca (OGT 918) as an oral treatment in patients with Gaucher’s disease who have been receiving Cerezyme replacement therapy. The 36-patient trial showed no clinically significant differences among three groups. The primary efficacy measure, liver volume, showed a statistically significant reduction from baseline to six months of -4.9 percent in the co-administration group compared to +3.6 percent in the control group. Quality of life data revealed that patients in the Vevesca group reported significantly greater treatment convenience (p=0.028) and improvements in overall treatment satisfaction (p=0.053), compared to those who received Cerezyme.
Phase 2 Discovery Inc., of Cincinnati, was awarded a $1 million Phase II Small Business Innovation Research grant from the National Institute of Neurological Disorders and Stroke of the National Institutes of Health, of Bethesda, Md. The grant will support the development of an early biomarker for predicting clinical outcome in patients with severe head injury.
Protein Design Labs Inc., of Fremont, Calif., said Laurence Jay Korn, a company co-founder and its CEO since 1987, resigned his position but will continue to serve as chairman of the board and remain active in investor relations and business development. Douglas Ebersole, Protein Design’s senior vice president for legal and licensing, will serve as interim CEO. Also, Daniel Levitt, president of research and development, resigned. Protein Design’s stock (NASDAQ:PDLI) dropped $3.43 Thursday, or 19.8 percent, to close at $13.90.
Servier Inc., of Paris, and GenOway SA, of Lyons, France, entered a nonexclusive, multitarget deal covering the in vivo validation of gene targets identified at the Institut de Recherches Servier. GenOway will use its target validation technologies to provide Servier predictable results on the quality of its targets. Financial terms of the one-year deal, which is renewable annually, were not disclosed.
Starpharma Ltd., of Melbourne, Australia, said two studies funded by the National Institutes of Health in Bethesda, Md., will assess Starpharma’s gel’s ability to prevent HIV/SIV and chlamydia infection in macaque monkeys. The gel contains a compound known as SPL7013 and is being developed as a topical vaginal microbicide for application by women before sex to provide broad-based protection against infection by sexually transmitted diseases. Starpharma said it is preparing an investigational new drug application for Phase I testing of the SPL7013 gel in humans.
Trigen Ltd., of London, transferred the drug discovery group of the Thrombosis Research Institute to its own operations. The group, which formed part of Trigen’s virtual organization, will be fully integrated into Trigen’s discovery capability. The group uses a multidisciplinary approach to structure-based design, including medicinal chemistry, molecular modeling, crystallography and protein engineering, within the cardiovascular field.
Variagenics Inc., of Cambridge, Mass., entered a pharmacogenomics collaboration agreement with Novartis Pharmaceuticals Corp., a unit of Novartis AG, of Basel, Switzerland, to study two Novartis compounds in clinical development for prostate cancer Gleevec and PKI 166. Variagenics will apply its integrated cancer pharmacogenomics platform to identify potential markers of drug efficacy for the compounds. Also, Variagenics will provide an exclusive license to Novartis for any markers that are predictive of therapeutic response, while Variagenics will retain exclusive rights to develop any resulting DNA diagnostic tests. Financial terms were not disclosed.