4SC AG, of Martinsried, Germany, entered a research collaboration with Schering AG, of Berlin, to identify molecules that bind to a specific undisclosed target provided by Schering to serve as the basis for drug discovery. 4SC will use its 4SCan high-throughput screening technology to evaluate a pool of 3.3 million small organic molecules for their binding efficacy to the given target. Schering will then receive a selection of ranked molecules for biological testing and further evaluation. 4SC will receive undisclosed research funding and milestone payments.
AEterna Laboratories Inc., of Montreal, reported at the American Society for Therapeutic Radiology and Oncology meeting in New Orleans that the Radiation Therapy Oncology Group joined the Community Clinical Oncology Program in patient enrollment of the Neovastat Phase III trial in non-small-cell lung cancer. The 760-patient trial, which will be completed in 2005, is sponsored by the National Institutes of Health in Bethesda, Md., and led by the University of Texas M.D. Anderson Cancer Center in Houston.
Ardais Corp., of Lexington, Mass., was awarded a two-year, $2 million Advanced Technology Program grant from the National Institute of Standards and Technology in Gaithersburg, Md. The funding will support the development of software technologies to help researchers understand the molecular basis of disease and select the biological targets of greatest clinical relevance for drug discovery.
Arius Research Inc., of Toronto, entered a research agreement with Protein Design Labs Inc., of Fremont, Calif., to evaluate two anticancer antibodies developed by Arius. During the research, Arius will receive funding. Should PDL exercise its option to license the antibodies, Arius would receive licensing fees and milestone payments, contingent upon future development outcomes, and would be entitled to a percentage royalty on any future net sales of anticancer drugs developed from the antibodies. PDL has the option to humanize, develop and market the two antibodies, ARH460-22-1 and ARH460-16-2.
Cell Pathways Inc., of Horsham, Pa., selected hormone-refractory prostate cancer as the lead cancer indication for clinical development of its investigational drug, CP461. Cell Pathways called the target attractive because of the activity seen even at low doses of CP461 in patients with prostate cancer. Also, past prostate cancer results with Aptosyn (exisulind), a drug that attacks the same molecular target as CP461, suggested moving forward with hormone-refractory prostate cancer as a lead oncology indication for CP461. Cell Pathways will continue to define a maximum tolerated dose for CP461, as well as complete Phase II studies in kidney cancer and chronic lymphocytic leukemia.
Cell Therapeutics Inc., of Seattle, reported at the American Society for Therapeutic Radiology and Oncology meeting in New Orleans that preclinical data showed that its drug candidate, Xyotax, when combined with radiation, improves tumor radioresponse, with an enhancement factor of 8.4 in fractionated radiation for a tumor-cure endpoint. It enhanced the radiotherapy effects without affecting normal cells. This fall, the M.D. Anderson Cancer Center in Houston will perform a Phase I/II study of Xyotax in patients undergoing radiation therapy for locally advanced lung cancer, sponsored in part by the National Cancer Institute, a unit of the National Institutes of Health in Bethesda, Md.
CytRx Corp., of Los Angeles, said its board approved the hiring of Sands Brothers & Co. Ltd. through an investment banking agreement focusing on potential strategic alliances, mergers and acquisition matters and corporate finance. Sands has offices in New York and London, among other locations. CytRx focuses on the development of high-value human therapeutics.
Entelos Inc., of Menlo Park, Calif., appointed Jon Saxe chairman of its board. From 1995 to mid-1999, Saxe was president of Protein Design Labs Inc., of Fremont, Calif. Entelos focuses on predictive biosimulation for in silico drug discovery and development.
Epicyte Pharmaceutical Inc., of San Diego, received from the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health in Bethesda, Md., a $600,000 grant to apply Epicyte's technology to produce on a large-scale hybrid antibodies to block the transmission of HIV. Epicyte will produce the hybrid antibody PRO 542, an HIV viral entry inhibitor developed at Progenics Pharmaceutical Inc., of Tarrytown, N.Y. PRO 542 yielded promising results in a recently completed Phase II trial. A second HIV hybrid antibody, sCD4-17b, developed at NIH, and PRO 140, an antibody to the HIV co-receptor CCR5 also developed by Progenics, will be produced in plants as part of the grant.
Genencor International Inc., of Palo Alto, Calif., and the University of Leicester in the UK will participate in a collaboration for microbial biotechnology between the European Union and the People's Republic of China. In the three-year, €1 million project to identify metabolic and genetic diversity as a source of new and valuable products, Genencor and the university will work with three other organizations to discover microbes, genes and enzymes from unique and remote Chinese environments in Inner Mongolia and Tibet. The other parties include the Institute of Microbiology of the Chinese Academy of Sciences in Beijing, the Department of Microbiology and Parasitology at the University of Seville in Spain and the Advanced Research Center for Applied Microbiology at the department of biotechnology of the University of the Western Cape at Cape Town, South Africa.
GenomeVision Services, the commercial services division of Genome Therapeutics Corp., of Waltham, Mass., received from the National Human Genome Research Institute, a unit of the National Institutes of Health in Bethesda, Md., a $1.6 million, two-year grant to further develop genomic technologies. GenomeVision Services will work to reduce the minimum amount of DNA needed, from microliters to nanoliters, for standard instruments to perform analysis using microtiter plates. GenomeVision Services also is developing plates that allow the removal of contaminants while still enabling the retrieval of the DNA in the sample for additional analysis. Genome Therapeutics retains all rights to the microtiter plates, which are available for licensing.
Human Genome Sciences Inc., of Rockville, Md., reported at the joint meeting of the Growth Hormone Research Society and the International Society for Insulin-like Growth Factor Research in Boston that Phase I results showed that Albutropin is well tolerated, has a prolonged half-life in the circulation and is biologically active in adults with growth hormone deficiency. Albutropin was capable of restoring IGF-1 levels to within the normal range in a dose-dependent manner. Nine of 14 patients, or 64 percent, responded after receiving single doses of Albutropin at 60 mcg/kg, and 66 percent (six of nine) responded after receiving two doses of Albutropin seven days apart at 60 mcg/kg.
IGEN International Inc., of Gaithersburg, Md., said its Origen Analyzer and related reagents were used by the U.S. Army Medical Research Institute of Infectious Disease and the Canadian government's Defense Research and Development laboratories to conduct anthrax field research tests. IGEN said the system was selected based on its capability to identify biological agents within 30 minutes. The field trials, conducted in July and August, tested soil, vegetation and naturally infected tissue samples.
ILEX Oncology Inc., of San Antonio, through its affiliate ILEX Pharmaceuticals LP, acquired global exclusive commercial rights to Campath (alemtuzumab)-related diagnostics, including CD52 antigen testing, from BTG International Ltd., of London. Campath targets the CD52 antigen to remove malignant lymphocytes from the blood, lymph nodes, bone marrow and other affected organs, though no standard diagnostic test exists to identify and quantify the presence of the CD52 antigen in cancer. Financial terms were not disclosed.
ISTA Pharmaceuticals Inc., of Irvine, Calif., submitted to the FDA on Sept. 30 the chemistry, manufacturing and controls clinical section of the new drug application for Vitrase, designed to treat vitreous hemorrhage. ISTA said it expects to submit the application's final component, concerning manufacturing validation, in the first quarter of next year.
Large Scale Biology Corp., of Vacaville, Calif., received a three-year, $2 million award from the Gaithersburg, Md.-based National Institute of Standards and Technology Advanced Technology Program to develop a new vaccine discovery and production platform. The award is expected to accelerate the development of a new generation of Geneware, the company's gene expression technology.
Orphan Medical Inc., of Minneapolis, released in the U.S. its Xyrem (sodium oxybate) oral solution. Sold to sleep centers and other physicians, Orphan called Xyrem the first and only approved medication to treat cataplexy, a debilitating symptom of narcolepsy. The drug received FDA approval nearly three months ago. (See BioWorld Today, July 19, 2002.)
Pharmacyclics Inc., of Sunnyvale, Calif., on Tuesday presented results from its first Phase III trial of Xcytrin (motexafin gadolinium) injection designed to treat brain metastases, at the 44th annual meeting of the American Society for Therapeutic Radiology and Oncology in New Orleans. Researchers concluded that Xcytrin, when added to whole-brain radiation therapy, significantly prolonged the time to neurologic progression and decreased deaths due to brain tumor progression in patients with brain metastases from lung cancer. Researchers also described the company's second Phase III trial, called the SMART trial (study of neurologic progression with motexafin gadolinium and radiation therapy), which is expected to begin enrolling patients by the end of this quarter. (See BioWorld Today, Jan. 8, 2002, and April 17, 2002.)
Pozen Inc., of Chapel Hill, N.C., submitted to UK regulatory authorities a marketing authorization application for MT 100, an oral tablet designed for first-line migraine therapy. Once approved, Pozen said it would seek European Union approval with the UK acting as a reference member state. Pozen is awaiting FDA approval in the U.S.
Rigel Pharmaceuticals Inc., of South San Francisco, said it is on track to have three drugs in clinical testing by the end of 2003. Rigel said that the Phase I safety trial for its first product, a drug for allergic rhinitis, was completed. The company plans to file an investigational new drug application with the FDA for that drug by year's end. The company's drug in the clinic, R112, is the first of a new class of drugs that works against mast cells, the company said. Rigel's third lead drug development program focuses on a new type of cancer target called ligases. The company's CEO made the comments at the UBS Warburg Global Life Sciences Conference in New York.
Scios Inc., of Sunnyvale, Calif., presented at the American College of Emergency Physicians Scientific Assembly 2002 in Seattle four abstracts related to Natrecor (nesiritide). The presentations showed the benefits of Natrecor as an early treatment strategy in patients with acutely decompensated heart failure presenting at the emergency department. One study found that the length of stay for patients who received IV vasoactive infusion therapy in emergency was 6.4 days vs. 9.5 days for those who started the therapy after admission (p<0.001).
Stressgen Biotechnologies Corp., of San Diego, presented at the International Papillomavirus Conference in Paris new scientific data on the mechanism of action for HspE7, the company's HPV-specific immunotherapeutic. Preclinical data demonstrated that HspE7 takes advantage of innate immunity, an early warning system used to generally detect and fight infection. The early defensive cells then send signals to the adaptive, antigen-specific immune system, such as T cells, which possess additional mechanisms to protect the body.
Targeted Genetics Corp., of Seattle, received $4 million after issuing 5.8 million shares of common stock at about 69 cents each to Biogen Inc., of Cambridge, Mass. Based on a September 2000 equity purchase commitment, the research and development collaboration is designed to develop up to four gene therapy products. Two programs have been identified in infectious disease and a genetic disorder.
V.I. Technologies Inc., of Watertown, Mass., reported publication in the Oct. 4, 2002, issue of Transfusion, the journal of the American Association of Blood Banks, of preclinical studies indicating Vitex's Inactine PEN110 treatment is an effective potential replacement for gamma-irradiation, currently the most common treatment for transfusion-associated graft-vs.-host disease, a severe complication following blood transfusions. The preclinical studies also suggest the potential of the Inactine PEN110 treatment to prevent alloimmunization, which occurs when a person who has repeated blood transfusions develops antibodies against the donated blood.
Xantos Biomedicine AG, of Munich, Germany, said it increased to 20,000 its collection of full-length human cDNA clones in mammalian expression vectors. Xantos said the expanded collection would increase the speed of its XantoScreen functional screening system and improve the frequency with which different biological assays can be conducted, resulting in more rapid and cost-effective target identification and validation.
Xerion Pharmaceuticals, of Martinsried, Germany, reported the closing of its third round of financing, which raised €12.3 million (US$12 million). New investor Heidelberg Innovation led the round, joined by Nextech Ventures, which co-led the round. Existing investors 3i, IKB Venture Capital and BioM AG also participated. Xerion attempts to bridge the process from target discovery to drug development by integrated functional identification and evaluation of disease-relevant drug targets followed by therapeutic antibody development against those high-quality targets.
YM Biosciences Inc., of Mississauga, Ontario, instructed its subsidiary, CIMYM, to return its license of the EGF vaccine to the licensor, CIMAB SA. Enrollment in a 66-patient, randomized, international trial of the EGF vaccine was completed recently; however, the license was returned based on an evaluation of the cost of continuing development of the product. YMB is an oncology-focused drug development company.
XOMA Ltd., of Berkeley, Calif., and Diagnostic Products Corp., of Los Angeles, expanded their licensing collaboration relating to XOMA's LBP (lipopolysaccaride binding protein) assay technology for the diagnosis and prognosis of diseases associated with exposure to Gram-negative bacteria and endotoxin. The original agreement, in which Diagnostic Products had the exclusive right to use XOMA's technology to develop diagnostic and prognostic products incorporating automated multisample analyzers generally used in hospitals and commercial reference laboratories, was expanded to give Diagnostic Products exclusive worldwide rights to use XOMA technology to develop non-automated, point-of-care, single-sample products. Additional financial and other terms were not disclosed.
Zymark Corp., of Hopkinton, Mass., said Vertex Pharmaceuticals Inc., of San Diego, purchased and installed two of Zymark's Allegro high-throughput screening systems for internal drug discovery work. The screening systems, a series of interlinked modular workstations with transfer stations, dispensers, storage carousels, incubators, plate washers and plate readers, will be used in conjunction with Vertex's technologies in several unnamed target areas. Financial terms were not disclosed.