Aastrom Biosciences Inc., of Ann Arbor, Mich., entered an agreement with Azienda Unita Sanitaria Locale di Ravenna, Oncologia Medica (AUSL) to purchase and use Aastrom's bone marrow stem cell therapy product for an experimental clinical approach in the treatment of breast cancer. AUSL will use the AastromReplicell System to generate bone marrow stem cells in the adjuvant treatment of high-risk breast cancer patients. The study is funded by the Italian government, and follows AUSL's recent purchase agreement for the AastromReplicell System platform and associated SC-I Therapy Kits.
Achillion Pharmaceuticals Inc., of New Haven, Conn., said it completed a Phase Ib/II trial demonstrating antiviral activity of its lead candidate, ACH-126,443 (Beta-L-Fd4C), in patients with chronic hepatitis B (HBV) infection. In the double-blind, multicenter trial, ACH-126,443 produced statistically significant and multilog decreases in HBV DNA levels during its 14-day dosing period. No drug-related adverse events were observed.
Aerogen Inc., of Mountain View, Calif., presented data at the American Thoracic Society International conference in Atlanta demonstrating that the Aeroneb Professional Nebulizer System (Aeroneb Pro) provides more efficient delivery of liquid aerosol when compared to pneumatic small-volume nebulizers (SVNs) during simulated mechanical ventilation. The Aeroneb Pro resulted in 13 percent drug deposition - the amount of drug deposited onto the filter - whereas SVNs resulted in 1 percent to 3 percent deposition.
Argenta Discovery Ltd., of Harlow, UK, and Pharmagene plc, of Royston, UK, entered two collaborations to optimize Pharmagene's R1 and R4 therapeutic programs through integrated medicinal chemistry, biochemical screening and early ADME (absorption, distribution, metabolism and excretion) studies. The R4 migraine collaboration is designed to develop a series of fully optimized candidate drugs. In the R1 irritable bowel syndrome collaboration, Argenta will optimize a series of compounds already identified by Pharmagene. Financial terms were not disclosed.
Cell Pathways Inc., of Horsham, Pa., reported at the American Gastroenterology Association meeting that daily treatment with 400 mg of exisulind (Aptosyn) significantly reduced the size of precancerous adenomatous colon polyps and prevented further polyp growth, compared to placebo. Results of the randomized, double-blind, placebo-controlled trial showed the drug's ability to reduce the formation of precancerous colon polyps in patients with familial adenomatous polyposis by 25 percent after 12 months of treatment and by an additional 54 percent at 24 months.
Centocor Inc., of Malvern, Pa., reported at the Digestive Disease Week meeting in San Francisco 54-week data from the ACCENT II trial suggesting the effectiveness of maintenance therapy with Remicade (infliximab) to close draining fistulas in Crohn's disease patients. Results of the 282-subject study showed that at week 30, 48 percent of Remicade patients showed complete fistula response, compared to 27 percent of placebo patients. At week 54, 36 percent on Remicade maintained complete response vs. 19 percent on placebo.
Cepheid Inc., of Sunnyvale, Calif., entered a multiyear distribution agreement with Bucher Biotec AG, of Basel, Switzerland, to market the Cepheid Smart Cycler system, accessories and disposable reaction tubes in the life sciences market in Switzerland. Bucher will provide marketing, sales and service support for the Smart Cycler line. Terms were not disclosed.
Cyanotech Corp., of Kailua-Kona, Hawaii, reported that a clinical trial showed BioAstin significantly reduced joint pain and improved physical performance in people with rheumatoid arthritis. The double-blind, placebo-controlled study, conducted by the Health Research and Studies Center in Los Altos, Calif., showed that BioAstin may be an important addition to rheumatoid arthritis treatment.
Enanta Pharmaceuticals Inc., of Watertown, Mass., said at the American Thoracic Society conference in Atlanta that it discovered a new class of cyclosporin analogues targeted to the treatment of asthma. The compounds can be delivered topically to the target organ and exert a local anti-inflammatory effect with reduced toxicity. Data confirmed that the novel cyclosporin analogues were active at suppressing the proliferation of human T cells and their ability to produce pro-inflammatory cytokines.
Enzon Inc., of Piscataway, N.J., adopted a rights plan under which its stockholders of record on June 3 will receive a dividend payable in preferred stock purchase rights. Each right will entitle stockholders to purchase a fractional share of Enzon's preferred stock for $190. The rights will become exercisable only if a person or group acquires or announces a tender or exchange offer that would result in the acquisition of 15 percent or more of Enzon's common stock while the stockholder rights plan remains in place. Also, if the rights are redeemed by Enzon for 1 cent each, or Enzon's board determines that an offer for all outstanding common stock is in the best interest of the company and the stockholders, the rights will become exercisable.
Evotec OAI AG, of Hamburg, Germany, entered a drug discovery collaboration with Taisho Pharmaceutical Co. Ltd., of Tokyo. Evotec will perform biology research and development on selected Taisho targets (including target expression and reagent production) and develop assays for those targets using Evotec's VLiP technology. Evotec will screen the targets against compounds from the Evotec corporate chemical library using EVOscreen, its ultra-high-throughput screening platform, and will characterize hits identified in the screening. Financial terms were not disclosed.
FeRx Inc., of San Diego, reported at the Digestive Disease Week meeting in San Francisco data from studies using its Magnetic Targeted Carrier (MTC) technology. Preclinical results suggest its MTCs are a feasible tool for drug delivery to the gastrointestinal tract and may be useful to treat diseases such as inflammatory bowl disease and cancerous tumors of the esophagus, stomach and colon, via an intra-luminal route of administration. FeRx previously demonstrated delivery of MTCs via intra-arterial and intra-vesical routes of administration, possibly leading to liver- and bladder-tumor treatment.
Gilead Sciences Inc., of Foster City, Calif., began a Phase I trial of the topical gel formulation of the antiviral tenofovir as a potential prevention method for vaginal transmission of HIV. Tenofovir is the active ingredient in Gilead's oral antiretroviral drug, Viread (tenofovir disoproxil fumarate), which was approved by the FDA in October and CE-marked in February as an anti-HIV treatment. Additionally, Gilead reported at the Digestive Disease Week conference in San Francisco data from several trials of its once-daily oral antiviral agent, adefovir dipivoxil 10mg. A meta-analysis was conducted on data from four ongoing studies of 256 chronic hepatitis B patients, all resistant to lamivudine. The data showed significant and sustained reductions in serum HBV DNA levels in patients following liver transplantation, decompensated liver disease and those co-infected with HIV. Also, two double-blind, placebo-controlled Phase III trials showed significant and comparable efficacy in 527 patients infected with the two major categories of chronic hepatitis B.
InterMune Inc., of Brisbane, Calif., reported at the American Thoracic Society conference in Atlanta that long-term follow-up data from a Phase II study of Actimmune (Interferon gamma-1b) for the treatment of idiopathic pulmonary fibrosis (IPF) demonstrated a mortality benefit in IPF patients randomly assigned to Actimmune vs. control treatment. The long-term follow-up included 18 patients from a randomized, controlled, open-label trial of Actimmune, in which 16 patients received one or more doses following study completion. Survival at five years was estimated to be 77.8 percent in the Actimmune group and 16.7 percent for control.
Invitrogen Corp., of San Diego, signed a licensing agreement with researchers at Columbia University in New York for specific Chinese hamster ovary (CHO) cell lines useful in drug discovery research and in the bioproduction of therapeutic proteins. The license granted to Invitrogen covers the sale of dhfr-negative CHO cells for research use only. However, it does not govern the sale of media used to maintain and grow those cells, either for research or bioproduction applications, and Invitrogen expects its customers to use the same Invitrogen media to which the dhfr-negative CHO cells have been adapted.
Marshall Edwards Inc., of Stamford, Conn., the U.S.-based subsidiary of Novogen Ltd., of Sydney, Australia, raised $10.1 million in an initial private placement from unnamed European, American and Australian investors and institutions. As a result of the placement, at $4 each, Marshall Edwards is now 95.2 percent owned by Novogen. At the same time, Marshall Edwards listed on the Alternate Investment Market of the London Stock Exchange under the symbol MSH. Marshall Edwards was established to provide a commercial vehicle for Novogen's anticancer drug technology, the first of which is phenoxodiol.
Micrologix Biotech Inc., of Vancouver, British Columbia, acquired two preclinical anti-infective programs from IntraBiotics Pharmaceuticals Inc., of Mountain View, Calif. As part of the acquisition, Micrologix entered a license and research agreement with BioSource Pharm Inc., of New York, which discovers and develops novel antibiotics. The agreements include a combination of up-front and near-term cash and equity components totaling $800,000 cash and/or equity payable and valued at specified milestones totaling up to $4.35 million for both programs and a royalty on product sales.
Nastech Pharmaceutical Co. Inc., of Bothell, Wash., presented at a panel discussion on Alzheimer's disease hosted by Cold Spring Harbor Laboratory preclinical data from its intranasal Acetylcholine Esterase inhibitor (AChE-I) research program. Intranasal delivery of AChE-I therapy, known as NP-7557, was shown to maintain effective plasma and cerebral spinal fluid concentrations at lower doses than the oral equivalent for the treatment of Alzheimer's disease. Concentration of the drug through nasal delivery was sevenfold higher at 30 minutes and two and a half times higher at 60 minutes than oral AChE-I.
Norak Biosciences Inc., of Research Triangle Park, N.C., relocated its offices and laboratories to Morrisville, N.C., moving out of the incubator facility at Becton-Dickinson Technologies. The new facility includes 6,000 square feet of lab space and 3,500 square feet of office space for the privately held developer of G protein-coupled receptor-based drugs.
Pharmasset Inc., of Atlanta, initiated an anti-HIV Phase I trial of Reverset, a nucleoside reverse transcriptase inhibitor that is also known as either D-D4FC or DPC-817. The studies are being conducted in the U.S. and Europe. The studies are designed to characterize the safety, tolerability and pharmacokinetics of single oral doses of RVT in HIV-1 infected subjects. Reverset is the topic of a paper published in the May 2002 issue of Antimicrobial Agents and Chemotherapy, the company said.
Protein Design Labs Inc., of Fremont, Calif., reported at the Digestive Disease Week conference in San Francisco preliminary results from a 42-patient, Phase I/II trial of its SMART Anti-Gamma Interferon Antibody in patients with moderate to severe Crohn's disease. Protein Design said that at the lowest dose, 50 percent of the patients responded and none had a remission. At a 1.0 mg/kg dose, 67 percent responded and 25 percent had a remission, and at the highest dose tested, 71 percent responded and 50 percent achieved a remission. In the placebo group, 60 percent responded and 40 percent achieved a remission.
The National Institutes of Health, of Bethesda, Md., said an altered mouse model of Duchenne muscular dystrophy, developed with high levels of insulin-like growth factor, showed an increase in muscle mass of at least 40 percent. The mouse also resulted in reduced amounts of muscle-replacing fibrous tissue and enhanced biological pathways associated with muscle regeneration. In addition, the hybrid mouse reduced muscle cell death.
Questcor Pharmaceuticals Inc., of Union City, Calif., said that research presented during the annual Digestive Disease Week meeting in San Francisco demonstrated its therapeutic probiotic product, VSL#3, provides clinical benefit to patients suffering from pouchitis. VSL#3 is a nonprescription preparation of live freeze-dried lactic acid bacteria developed specifically to provide the optimal concentration and types of healthy bacteria for the gastrointestinal tract. The study involved 36 patients with active refractory or recurrent pouchitis who had successfully been brought into remission by antibiotics. The study revealed that 90 percent of the group on VSL#3 effectively remained in remission while 94 percent of the group on placebo relapsed.
Rigel Pharmaceuticals Inc., of South San Francisco, said Novartis Pharma AG, of Basel, Switzerland, accepted a drug target from the companies' research collaboration, resulting in a milestone payment to Rigel. Also, Novartis elected to cancel the research phases of the companies' two initial joint projects in autoimmunity and transplant rejection, after 42 months each, taking effect by February 2003. Since being initiated in 1999, Novartis has contributed $750,000 of research funding to Rigel each quarter per program.
SciClone Pharmaceuticals Inc., of San Mateo, Calif., reported at the Digestive Disease Week conference in San Francisco results of a study demonstrating that Zadaxin (thymalfasin, thymosin alpha 1) upregulates the expression of multiple immune system-related genes in na ve, nonresponder and sustained-responder hepatitis C patients. SciClone's Phase III combination Zadaxin and pegylated interferon hepatitis C trial involves 1,000 nonresponder patients in the U.S. The addition of pegylated interferon to Zadaxin did not significantly alter the pattern of upregulation.
Sequenom Inc., of San Diego, developed a method for rapid large-scale bacterial identification, as published in the latest edition of the Proceedings of the National Academy of Sciences. The new method, which can be used to determine the genetic barcode of any bacterial specimen, is based on a combination of DNA amplification, base-specific cleavage and Maldi-Tof mass spectrometry, the same technology used in Sequenom's MassArray genotyping platform. The company expects to commercially launch the SNP discovery application during the fourth quarter of 2002.
Targeted Genetics Corp., of Seattle, presented at the Liposome Days Research conference in Berlin data from Emerald Gene Systems, its joint venture with Elan Corp. plc, of Dublin, Ireland, that showed improved gene expression and tumor cell targeting of synthetic gene delivery systems designed for use in cancer treatments. Results showed decreased nonspecific interactions with serum and cells with tumor-specific gene expression increased from eightfold to 150fold. Also, reduced inflammatory responses were demonstrated in levels of TNF-alpha, a marker for inflammation, by a decrease of up to 158fold.
Tranzyme Inc., of Birmingham, Ala., and Targacept Inc., of Winston-Salem, N.C., entered a development and license agreement to develop a bioassay to be used for drug discovery for diseases of the central nervous system. Tranzyme will employ the combination of its technologies for gene transfer (TranzVector) and assay development (TranzAssay) to develop a cell-based assay expressing nicotinic acetylcholine receptors provided by Targacept. Tranzyme will receive development support and downstream royalties on products screened by Targacept using the bioassay. Tranzyme will retain rights to develop and use the bioassay for its internal neurosensory drug discovery efforts. Financial terms were not disclosed.
Vernalis Group plc, of Cambridge, UK, began Phase I trials with the first candidate from its collaboration with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, on obesity, triggering a further milestone payment to Vernalis. The program focuses on 5-HT(2C) receptor agonists that target the mechanism of appetite control. Vernalis also began Phase II trials of VML 670 in sexual dysfunction experienced by patients taking SSRI antidepressants. Vernalis will conduct the study, at the end of which Eli Lilly & Co., of Indianapolis, has an option to complete and fund further development, in return for milestone and royalty payments.
Xcyte Therapies Inc., of Seattle, obtained an exclusive license from the trustees of the University of Pennsylvania for all human therapeutic rights related to a genetically modified cell line that could be used to activate and grow T cells. The Xcellerate Technology employs proprietary beads that deliver signals required to activate a patient's T cells, which can then be used to treat a range of diseases. Financial terms were not disclosed.