¿ AP Pharma Inc., of Redwood City, Calif., said it completed a series of preclinical safety studies on its polymer-based Biochronomer system. The system is designed as a bioerodible injectable and implantable drug delivery system for pain management, inflammation oncology, and ophthalmic and orthopedic applications. According to the studies, the system is safe following subcutaneous administration at dose levels in excess of anticipated clinical use, the company said. AP Pharma is a pharmaceutical company that develops polymer-based drug delivery systems.
¿ Applied Molecular Evolution, of San Diego, filed a patent infringement suit against MorphoSys AG, of Munich, Germany, and its wholly owned subsidiary, MorphoSys USA Inc. Applied Molecular Evolution alleges that MorphoSys is willfully infringing Kauffman patents under which AME holds exclusive rights covering methods of stochastically generating proteins. AME was granted an exclusive license to the Kauffman patent family in 1994 and has established a broad licensing program that has resulted in the nonexclusive sublicensing of the asserted patents to a number of companies. AME develops directed evolution to improve health care. Directed evolution involves optimizing genes and proteins for specific commercial purposes.
¿ BioMimetic Pharmaceuticals Inc., of Nashville, Tenn., said it received an investment from Novo A/S, the holding and venture capital arm of the Novo Group. Novo A/S is a significant shareholder in Novo Nordisk A/S, of Bagsvaerd, Denmark. The amount of the investment was not disclosed. BioMimetic is developing products based on the principles of tissue engineering and biomimetics.
¿ Caprion Pharmaceuticals Inc., of Montreal, said it will combine software, hardware and technologies from Sun Microsystems and Oracle and the services of CGI with its own cell biology and mass spectrometry techniques to analyze, map and store the protein differences between normal and diseased cells. The highly scalable bioinformatics platform for protein disease modeling will be part of Caprion¿s CellCarta drug discovery service. Financial terms were not disclosed.
¿ Cell Therapeutics Inc., of Seattle, said it developed a proprietary way to allow bacteria to make its polyglutamate (PG) polymer, expanding the application of PG to include a wide variety of biologic therapies such as interferon. Jack Singer, executive vice president of research, said, ¿We believe this is the first time a polymer has been produced using recombinant techniques. We can now genetically engineer bacteria to produce PG-interferon and PG linked with other biologic agents active in treating cancer.¿ The company said that its research showed that PG-interferon has several characteristics that may allow it to be superior to other polymer-linked interferons.
¿ Genomics Collaborative Inc., of Cambridge, Mass., a clinical functional genomics company, launched its GCI Access, a subscription-based service that provides researchers with access to GCI¿s database of clinical data and DNA, tissue and sera samples collected from more than 100,000 patients. The company said that GCI Access will enable researchers to accelerate the discovery and validation process by accessing large numbers of samples in major disease states, including inflammatory, cardiovascular and metabolic disorders, as well as several cancers.
¿ Genzyme General, a division of Genzyme Corp., of Cambridge, Mass., reported first-year results from its three-year ¿Treat to Goal¿ clinical trial. According to the company, the study has demonstrated that patients with end-stage renal disease taking calcium-based phosphate binders to control serum phosphorous levels experienced a 25 percent increase in their coronary artery calcification scores after one year. Patients, however, taking the company¿s Renagel experienced a 6 percent increase compared to baseline, the company said. Renagel patients also showed a 5 percent increase in aortic calcification scores, while other patients showed a 28 percent increase. The study used electron beam tomography scanning to measure volume and density of calcification within the heart. The study was an open-label, randomized trial in 15 medical centers in the U.S. and Europe, with 202 patients enrolled.
¿ Immunomedics Inc., of Morris Plains, N.J., presented new findings at the 48th annual meeting of the Society of Nuclear Medicine on the company¿s LeukoScan infectious disease imaging agent. Researchers reports that LeukoScan, which has been marketed by Immunomedics in Europe since 1997, located such pathological findings as endocarditis and pericarditis, pneumonia and infections of abdominal organs, especially in patients with fever of unknown origin. The company said that after injection, LeukoScan¿s antibody leaves the body rapidly and accumulates at sites of inflammation, where the white blood cells are deposited.
¿ Interferon Sciences Inc., New Brunswick, N.J., presented positive results at the 17th World Congress Neurology Meeting in London from a study covering the reduction of gadolinium-enhanced brain lesions in multiple sclerosis (MS) using interferon alfa-n3 (Interferon Science¿s Alferon N). Brain MRIs were performed on 69 MS patients either treated with interferon alfa-n3 or untreated as a control. The images revealed, according to the company, the presence of gadolinium-enhanced lesions in the brain in two out of 31 patients treated with interferon alfa-n3 for three to six months, as compared to 14 out of 38 patients in the untreated group.
¿ Invitrogen Corp., of Carlsbad, Calif., reached an agreement to sell its BioSepra chromatography business for $12 million in cash to Ciphergen Biosystems Inc., of Fremont, Calif. The transaction is expected to close within 60 days. Also, the companies executed a collaboration agreement to assess the feasibility of integrating the technologies of product platforms of both companies. Invitrogen develops, manufactures and markets research tools in kit form.
¿ Lexicon Genetics Inc., of The Woodlands, Texas, reported discovering a novel gene called Neph1, which the company said may play an important role in maintaining the filtration barrier that prevents nephrotic syndrome, a condition that can lead to kidney failure. The discovery team found that genetically engineered knockout mice lacking Neph1 had extremely high levels of urine protein, the primary characteristic of nephrotic syndrome. In addition, structural changes found in the kidneys of the mice are similar to lesions present in some forms of nephrotic syndrome that often progress into scarring and result in kidney failure. Company scientists found that the Neph1 gene is located on human chromosome 1 in a region previously linked to a severe form of childhood nephrotic syndrome present in multiple members of a number of families.
¿ Nobex Corp., of Research Triangle Park, N.C., presented data from ongoing Phase II studies of its oral insulin product for the treatment of diabetes at the American Diabetes Association meeting in Philadelphia. The results showed positive safety and efficacy trends in both Type I and Type II diabetic patients. The study included 51 total patients. Nobex¿s drug is the first oral insulin product to demonstrate clinical effects in controlling glucose both after a meal and during the fasting state, the company said.
¿ Oxigene Inc., of Watertown, Mass., presented data at BIO 2001 showing that its vascular targeting agent Combretastatin (CA4P) has, according to Oxigene, profound effect on tumor growth and microvasculature in a murine liver metastatic model. According to research from a recent study, CA4P, when used alone, significantly decreases the percentage of colorectal tumor metastasis to the liver. The company said the work showed ¿dramatic effects¿ after only one hour of treatment with no damage to normal tissue.
¿ Quark Biotech Inc., of Pleasanton, Calif., and ES Cell International Pte Ltd., of Singapore, formed a joint human embryonic stem cell research program to discover the underlying cause of human embryonic stem cell differentiation and self-renewal. According to a joint release, the initial goal of the program is to ¿understand and master¿ novel methods of growth of human embryonic stem cells (hES) and their inhibition and differentiation into specific lineages. The companies will use Quark Biotech¿s technology platform to discover new genes such as growth factors derived from hES cells. The long-term goal, according to the companies, is to develop pharmaceutical products and therapies, diagnostic products and screening assays based on identified genes.
¿ Senetek plc, of Napa, Calif., said that it received a two-year extension on promissory notes outstanding, from April 14, 2002, to April 14, 2004. In consideration, the company has issued an additional 341,747 shares and reduced the stake price of existing warrants. The company also reported establishing a convertible preferred line of credit up to $1 million. The revolving credit line calls for Senetek to pay a 5 percent transaction fee in stock or cash on the amount drawn, if any. Senetek develops products for the treatment of sexual dysfunction and anti-aging.
¿ Sigma-Genosys, of Houston, and Compugen Inc., of Princeton, N.J., have formed an alliance to design and manufacture OligoLibraries, co-branded genome-wide oligonucleotide collections. OligoLibraries is designed to provide the life sciences and research communities with access to oligonucleotide collections representing genomes of various organisms for high-throughput analysis of gene function. According to a joint release, Compugen will provide the content and designs of the OligoLibraries and Sigma-Genosys will manufacture the products.
¿ SuperGen Inc., of Dublin, Calif., said that in preclinical studies of prediabetic GMI fa/fa Zucker rats, which are models for human Type II diabetes, glucose and triglyceride levels decreased after administration of a compound called DHEA phosphocholine. DHEA phosphocholine is one of the novel compounds that were included in SuperGen¿s acquisition of Amur Pharmaceuticals last year. Results of the study were presented at the 61st scientific session of the American Diabetes Association in Philadelphia.
¿ Symyx Technologies Inc., of Santa Clara, Calif., entered into an agreement with Merck & Co. Inc., of Whitehouse Station, N.J., to develop a Discovery Tools system for the discovery, identification and characterization of novel crystalline sale and polymorphic forms of drug candidates for use in clinical trials. Merck will provide funding for Symyx¿s development effort and will purchase a Polymorph Discovery Tools system upon completion and validation.
¿ Texas Biotechnology Corp., of Houston, and its majority-owned subsidiary, Revotar Biopharmaceuticals AG, of Berlin, initiated a Phase I study using the inhaled formulation of bimosiamose, a selectin antagonist. The Phase I 48-patient trial is a double-blind, placebo-controlled, ascending, single-inhaled dose study to determine the safety and tolerability of bimosiamose as an inhaled therapy for asthma.
¿ Tripos Inc., of St. Louis, signed an agreement with molecular modeling software developer Molecular Discovery Ltd., of London, to distribute VolSurf, a program for predicting and optimizing pharmacokinetic properties of potential drug candidates.
¿ Vasogen Inc., of Toronto, said it completed patient enrollment in its double-blind, placebo-controlled clinical trial in congestive heart failure (CHF). The trial is designed to investigate the impact of the company¿s immune modulation therapy on the pathological processes involved in CHF. The study is scheduled to be completed by the end of the year. The 60-patient trial will be held at four different centers in the U.S. and Canada.
¿ Alliance Pharmaceutical Corp., of San Diego, acquired an ownership position in Metracor Technologies Inc., of San Diego. Alliance has been collaborating with Metracor on the development of RODA (Real-Time Oxygen Dynamics Analysis), a cardiovascular and oxygenation monitoring device. In exchange for the payment of $500,000 in cash and the transfer of its RODA technology to Metracor, Alliance will receive approximately 5 percent of Metracor and an option to increase its ownership to approximately 35 percent by paying $14.1 million or the issuance of 1.97 million shares of Alliance common stock, at Alliance¿s discretion, at any time prior to December 2002. Alliance also has an option to acquire an additional 10 percent of the company in exchange for either 666,000 shares of Alliance stock or $4.7 million during this period. Alliance may be required to exercise these options under certain circumstances.
¿ Atrix Laboratories Inc., of Fort Collins, Colo., said it received a $3 million milestone payment from Sanofi-Synthelabo, of Paris, for filing a new drug application with the FDA for Leuprogel One-Month Depot, leuprolide acetate for subcutaneous depot injection, for treatment of advanced prostate cancer.
¿ Biolog Inc., of Hayward, Calif., said it developed a new high-throughput cell analysis tool capable of measuring hundreds of thousands of cellular properties simultaneously. The work was reported in the July issue of the journal Genome Research.
¿ Crucell NV, of Leiden, the Netherlands, signed a licensing and production agreement with Selective Genetics Inc., of San Diego. Selective Genetics will receive a nonexclusive license to Crucell¿s PER.C6 cell line. Crucell will manufacture clinical-grade batches of Selective Genetics¿ PER.C6-derived gene therapy product using its human cell line production platform. Crucell will receive up-front and annual payments for the license and additional fees for the production of preclinical batches. Crucell could receive additional payments and royalties on future sales of PER.C6-derived products. Further financial details were not released.
¿ CV Technologies Inc., of Edmonton, Alberta, said it completed its Phase II trial on CVT-E002, a drug candidate for health issues surrounding upper respiratory infections, such as cold and flu. The preliminary analysis of the results indicates a decreased incidence of laboratory-confirmed acute respiratory illness when compared to placebo, the company said.
¿ Inhale Therapeutic Systems Inc., of San Carlos, Calif., reported new data released from its Phase III studies being conducted by Pfizer Inc., of New York, and Aventis Pharma AG, of Frankfurt, Germany, at the American Diabetes Association 61st Annual Scientific Session in Philadelphia. Results from two additional Phase III studies suggested patients with Type I diabetes using inhaled insulin (Exubera) multiple times a day with one bedtime, long-acting injection achieved comparable control of blood glucose to that seen in patients receiving multiple daily injections. Data from the second study showed patients who were poorly controlled on a combination of two oral diabetes therapies demonstrated improved glycemic control and greater overall satisfaction and acceptance of therapy when inhaled insulin was added to their treatment regimen or when it replaced oral therapies.
¿ MorphoSys AG, of Munich, Germany, said a lawsuit initiated by Cambridge Antibody Technology Ltd., of Melbourn, UK, together with the Medical Research Council and the Scripps Research Institute, alleging infringement of their ¿Winter II¿ U.S. patent has been dismissed by the U.S. District Court for the Southern District of California in San Diego. The lawsuit was filed by CAT on June 19, and dismissed on June 22 for lack of jurisdiction and improper venue. MorphoSys has filed an action for declaratory judgment in the U.S. District Court for the District of Columbia in Washington.
¿ Peregrine Pharmaceuticals Inc., of Tustin, Calif., presented preliminary results from a Phase I/II malignant tumor trial with Peregrine¿s tumor necrosis therapy drug, Cotara, at the Society of Nuclear Medicine meeting in Toronto. The study evaluated the drug for the treatment of primary and unresectable cancers of the pancreas, liver, prostate or brain. The drug was well tolerated and positive results were seen. Cotara is a radiolabeled monoclonal antibody that binds to the necrotic core of tumors and uses beta-radiation to kill tumors from the inside out, the company said.
¿ Symbollon Pharmaceuticals Inc., of Framingham, Mass., said it intends to proceed to pivotal Phase III trials for IoGen for the treatment of pain and tenderness associated with fibrocystic breast disease. The company expects to be enrolling patients in the Phase III trials early in the first quarter of 2002. The company said it expects to enroll about 1,500 patients in the trial and it should last 15 to 18 months.
¿ VaxGen Inc., of Brisbane, Calif., presented laboratory data at the sixth European Conference on Experimental AIDS Research in Edinburgh, Scotland, indicating that antibodies to HIV subtype C have an unexpected ability to bind to significant regions of another HIV subtype. The findings indicate that a vaccine that induces HIV-C antibodies may be effective at preventing infection not only by HIV-C, but also by other subtypes, the company said. VaxGen also described a new trivalent formulation of its vaccine, AIDSVAX, designed to prevent infection by three of the world¿s five major HIV subtypes.
¿ Versicor Inc., of Fremont, Calif., started a Phase II study to evaluate its product, anidulafungin, for the treatment of invasive candidiasis/candidemia. The study will enroll about 120 hospitalized patients in the U.S. with a documented diagnosis of invasive candidiasis/candidemia. Patients will be treated with a single daily intravenous infusion of anidulafungin at three different doses for 15 to 42 days.