¿ Alliance Pharmaceutical Corp., of San Diego, received proceeds of approximately $15 million in conjunction with a private placement of common stock at $3.50 per share to a group of institutional and individual investors. Investors also received warrants to purchase approximately 4.3 million shares of common stock at $4.20 per share. Proceeds will be used to seek final FDA approval for Alliance¿s Imavist ultrasound contrast agent, to continue the clinical development of the company¿s intravascular oxygen carrier, Oxygent, and for working capital. Participants in the private placement include Special Situations Funds and EndPoint Group Late Stage Fund. Roth Capital Partners served as Alliance¿s placement agent for the transaction. (See BioWorld Today, Sept. 4, 2001.)
¿ Ariad Pharmaceuticals Inc., of Cambridge, Mass., reported a direct equity placement of about 1.9 million shares of its common stock to selected institutional investors at $4.15 per share for gross proceeds of $8 million. Ladenburg Thalmann & Co. Inc. served as placement agent for the offering. The shares were offered through a prospectus supplement pursuant to the company¿s effective universal shelf registration statement.
¿ Boston Life Sciences Inc., of Boston, completed the required pre-investigational new drug application one-month toxicology tests of its antiangiogenic protein, Troponin I. The company is developing Troponin for the prevention and treatment of metastases from solid tumors in patients who are at high risk for such metastatic recurrence. These tests evaluated the toxic potential of recombinant human Troponin when administered as a continuous infusion for a one-month period in both rats and primates, incorporating doses up to ten times the anticipated dose to be used in human trials. Preliminary evaluation revealed no adverse effects on any organs, and blood tests revealed no significant abnormalities in hematologic or chemistry parameters.
¿ Celgene Corp., of Warren, N.J., reported preclinical studies that show a small-molecule inhibitor of a protein kinase appears to inhibit the growth of breast and prostate tumors. The research determined that inhibition of the JNK (c-Jun N-terminal kinase) pathway in animal models of cancer blocked intracellular signals that occur during tumor cell growth and blood vessel proliferation. These findings were presented at the American Association for Cancer Research-National Cancer Institute-European Organization for Research and Treatment of Cancer (AARC-NCI-EORTC) conference in Miami Beach, Fla.
¿ Corporate Technology Development Inc., of Miami, initiated a phase II trial to evaluate orBec¿s efficacy in treating Crohn¿s disease. CTD previously announced that it entered into a definitive merger agreement with Endorex Corp., of Lake Forest, Ill., providing for Endorex¿s acquisition of CTD. This is the second clinical trial initiated with orBec and is a dose-ranging, multicenter, placebo-controlled Phase II trial involving 48 patients at six gastrointestinal centers in the United States.
¿ Eukarion Inc., of Bedford, Mass., and the Buck Institute for Age Research, of Novato, Calif., said the November 2001 issue of the Journal of Neuroscience details experiments in which neurodegenerative diseases such as Parkinson¿s and Alzheimer¿s may be attenuated through the use of certain drugs, known as synthetic catalytic scavengers of reactive oxygen species. The report details experiments in which treatment with SCSs rescued a neurological phenotype in mice engineered to undergo a specific form of oxidative damage. Treatment with the SCSs also resulted in increased lifespan of the mice.
¿ ImClone Systems Inc., of New York, and Bristol-Myers Squibb Co., also of New York, completed the rolling biologics license application for IMC-C225, now called Erbitux, for the treatment of irinotecan-refractory colorectal cancer. The investigational monoclonal antibody is designed to target and block epidermal growth factor receptor. ImClone began the enrollment process in June. Bristol-Myers signed the deal in September to help promote and develop the compound in a potential $2 billion deal. (See BioWorld Today, June 29, 2001, and Sept. 20, 2001.)
¿ Genicon Sciences Corp., of San Diego, entered a multiyear agreement with the Genomics Institute of the Novartis Research Foundation (GNF), of San Diego, to employ Genicon¿s Resonance Light Scattering (RLS) technology for use in GNF¿s internal proteomic microarray research. Genicon and GNF will collaborate to further develop and commercialize RLS technology in conjunction with GNF¿s proteomic microarray technologies for the discovery of new drugs and drug targets. Genicon will receive certain rights to GNF¿s microarray technologies to further develop and commercialize RLS technology for application to murine antibody arrays and protein microarray tool kits. GNF will receive the rights to employ RLS technology in its internal biomedical discovery programs and with research partners. Financial terms were not disclosed.
¿ Human Genome Sciences Inc., of Rockville, Md., said the FDA approved its investigational new drug application to begin clinical trials of LymphoStat-B as a potential new treatment for autoimmune diseases. HGS will proceed with a Phase I trial in patients with systemic lupus erythematosus. The trial will be a multicenter, dose-escalation study to determine the safety and pharmacology of the drug in adult patients who are receiving standard therapies. LymphoStat-B also may be tested in patients with other autoimmune diseases, such as rheumatoid arthritis, immune thrombocytopenic purpura and Sjogren¿s syndrome.
¿ ImmunoGen Inc., of Cambridge, Mass., reported favorable safety data from the initial 27 patients enrolled in a clinical trial of its tumor-activated prodrug, huC242-DM1/SB-408075, for the treatment of colorectal, pancreatic and certain non-small-cell lung cancers. In addition, evidence of antitumor activity in several patients was reported. These results of the dose-escalating, multidose Phase I/II study will help to determine the protocols for broader Phase II trials. These findings were presented at the AACR-NCI-EORTC conference in Miami Beach, Fla.
¿ Introgen Therapeutics Inc., of Austin, Texas, reported that INGN 251, its PTEN gene drug, inhibits human colorectal tumors in animals. The data showed INGN 251 delivered the anticancer PTEN gene into cells using Introgen¿s delivery system and inhibited the growth of cancer cells, the company said. The findings were presented at the AACR-NCI-EORTC conference in Miami Beach, Fla., and the presentation abstract will be published in a supplement to the November 2001 issue of Clinical Cancer Research.
¿ Maxim Pharmaceuticals Inc., of San Diego, detailed its upcoming randomized, controlled Phase II trial of its product candidate, Ceplene (histamine dihydrochloride), in triple combination therapy for the treatment of patients infected with hepatitis C. The study is designed to compare the treatment of nonresponder hepatitis C patients with a triple-drug combination of Ceplene, Peg-Intron (peginterferon alfa-2b) ¿ belonging to Schering Corp., a subsidiary of Schering-Plough Corp., located in Madison, N.J. ¿ and Rebetol (ribavirin, USP), vs. treatment with Peg-Intron and Rebetol combination therapy alone. Expected to enroll up to about 280 patients with hepatitis C who failed to respond to the combination of interferon-alpha and ribavirin, the primary measures in the study will be viral response, biochemical response and histological improvement measured from tissue biopsies. The study is planned to begin in Europe and Israel before the end of the year.
¿ Metabasis Therapeutics Inc., of San Diego, received a $153,103 Phase I Small Business Innovation Research grant by the National Institute of Diabetes and Digestive and Kidney Diseases. The grant is the second awarded to Metabasis in the past three months for drug discovery research on liver diseases. It supports research focused on compounds that activate adenosine receptors and their use with the company¿s HepDirect Technology, for treating liver fibrosis.
¿ Neurocrine Biosciences Inc., of San Diego, received a phase II Small Business Innovation Research grant from the National Institutes of Health, of Bethesda, Md., to fund the development of orally active GnRH receptor antagonists. The $1 million, two-year grant will support research on small-molecule GnRH receptor antagonists for the treatment of uterine fibroids, endometriosis, breast cancer, prostate cancer, infertility and other disorders linked to the reproductive endocrine system. In addition, Neurocrine has selected an orally active GnRH antagonist development candidate for the treatment of endometriosis, uterine fibroids and prostate cancer. Phase I studies are scheduled to begin in the fourth quarter.
¿ NexMed Inc., of Robbinsville, N.J., conducted two U.S. Phase II studies for Alprox-TD. The studies were randomized, parallel, double blind, placebo controlled and were designed to investigate the dose-response relationships of the efficacy and safety of escalating doses of Alprox-TD in 300 men with mild, moderate and severe erectile dysfunction. Up to 83 percent of patients reported satisfaction with treatment. Side effects were mostly mild to moderate and short in duration.
¿ Repligen Corp., of Needham, Mass., said it intends to enroll about 300 children, aged 3 to 6, with moderate to severe symptoms of autism in two Phase III trials. The primary endpoints will be improvements in the parental Clinical Globe Impression of Change and improvements in social interaction as measured with the Autism Diagnostic Observation Schedule. The company said it intends to submit a complete clinical protocol to the FDA by year¿s end.
¿ NPS Pharmaceuticals Inc., of Salt Lake City, earned a $1 million milestone payment from Forest Laboratories Inc., of New York, for achieving certain events related to Forest¿s preclinical work with ALX-0646 for treating migraine. The ALX-0646 compound appears less likely to cause cardiovascular side effects than other migraine treatments on the market, the company said. It acts selectively on certain serotonin receptor subtypes in the brain and has low affinity for serotonin receptors in cardiovascular tissue. Forest has worldwide rights to develop ALX-0646 for the treatment of migraine.
¿ Onyx Pharmaceuticals Inc., of Richmond, Calif., presented data showing that when given intravenously at high doses to mice bearing human tumor xenografts, ONYX-411 demonstrated significant antitumor efficacy, without associated toxicity to normal organs. In data presented from preclinical studies, researchers showed that CD-ATV provided an enhanced antitumor response in the presence of 5-FC, and correlated with high intratumoral concentrations of 5-FU, but subtoxic levels systemically. These findings were presented at the AACR-NCI-EORTC conference in Miami Beach, Fla. Separately, Onyx and Bayer AG, of Leverkusen, Germany, presented Phase I data for BAY 43-9006, an anticancer small-molecule Raf kinase inhibitor. BAY 43-9006 selectively blocks signal transduction in the Ras pathway by inhibiting a specific enzyme known as Raf kinase, the company said. BAY 43-9006 was co-discovered and is being developed by Onyx and Bayer.
¿ Telik Inc., of South San Francisco, reported preclinical results with its TLK199 small-molecule product for the potential treatment of blood disorders associated with low white blood cell levels. The data suggest that elevated activity levels of glutathione S-transferease P1-1 (GST P1-1) activity can negatively influence proliferation of white blood cells. TLK199 inhibits GST P1-1 and may have therapeutic potential as a small-molecule myeloproliferative agent. These findings were presented at the AACR-NCI-EORTC conference in Miami Beach, Fla. Telik¿s stock (NASDAQ:TELK) rose $1.40, or about 18 percent, to close at $9.25.