¿ Access Pharmaceuticals Inc., of Dallas, said its board of directors declared a special dividend distribution of a preferred share purchase right for each outstanding share of the company¿s common stock as part of a stockholders rights plan.
¿ Aclara BioSciences Inc., of Mountain View, Calif., entered a collaboration with Roche Applied Science, a business area within Roche Diagnostics, of Basel, Switzerland, for the worldwide marketing and distribution of Aclara¿s Arteas product line. Arteas LabCard devices enable biological assays to be performed at volumes 10 to 100 times smaller than conventional microwell plates. Roche also obtained rights to negotiate for the distributorship of certain Aclara products based on LabCard devices.
¿ Alteon Inc., of Ramsey, N.J., expanded the clinical testing of ALT-711, its lead A.G.E. Crosslink Breaker, into patients with end-stage renal disease (ESRD) who are undergoing peritoneal dialysis (PD). ALT-711 is concurrently in two Phase IIb trials, evaluating its effectiveness on systolic hypertension in individuals with or without left ventricular hypertrophy. The Phase I safety and pharmacokinetic study will evaluate the way ALT-711 is metabolized in PD patients with ESRD. Recruited patients will receive drug or placebo in tablet form daily, and the dosage will be increased over a four-week period.
¿ Amarillo Biosciences Inc., of Amarillo, Texas, said its orally administered interferon alpha will be tested as a treatment for idiopathic pulmonary fibrosis (IPF) under an Advanced Technology Program grant awarded by the state of Texas to the Texas Tech University Health Sciences Center in Lubbock. The $100,000 grant will be used by the Health Sciences Center to support a pilot study of 20 patients with IPF. Amarillo Biosciences will collaborate on this research, and will provide in-kind support in the form of study drug, data management and biostatistical analysis.
¿ AnorMED Inc., of Vancouver, British Columbia, said results of a Phase I study of AMD-3100 showed it rapidly mobilizes stem cells out of bone marrow and into the circulatory system. The data support the potential use of AMD-3100 in stem cell transplants to treat cancers involving blood and immune systems, such as leukemias, multiple myeloma and lymphomas. The study, at the University of Washington in Seattle, involved 10 patients who received a single subcutaneous injection of the drug.
¿ Antigenics Inc., of New York, initiated a Phase I study of AG-702 for herpes simplex virus type-2 (or genital herpes) at the University of Washington Virology Research Clinic in Seattle. AG-702 is the first recombinant vaccine for the treatment of an infectious disease using Antigenics¿ heat shock protein (HSP) technology to advance to the clinic. AG-702 is a recombinant human HSP, complexed to a synthetic peptide derived from HSV-2. The dose-escalation study will enroll 40 patients, half of whom have evidence of prior HSV-2 infection and half who have no evidence of prior infection.
¿ Celera Genomics Group, of Rockville, Md., and Compaq Canada Corp., of Richmond Hill, Ontario, entered into an exclusive agreement naming Compaq Canada the preferred distributor of access to the Celera Discovery System ¿ Celera¿s bioinformatics platform of database content, analysis and visualization tools ¿ to the non-profit research community in Canada.
¿ Cell Therapeutics Inc., of Seattle, presented data demonstrating that Trisenox (arsenic trioxide) induces durable overall and relapse-free survival in patients with relapsed or refractory acute promyelocytic leukemia. After following patients for a median of 30 months, the two-year overall survival rate was 63 percent and the two-year, relapse-free survival rate was 49 percent. The data combined results of a 12-patient pilot study and a 40-patient, pivotal multicenter trial. The results were presented at the Chemotherapy Foundation Symposium in New York.
¿ Corporate Technology Development Inc., of Miami, initiated a Phase II trial to evaluate orBec¿s efficacy in treating Crohn¿s disease. This is the second clinical trial that CTD has initiated with its lead product. The study is a dose-ranging, multicenter, placebo-controlled Phase II trial in 48 patients at six U.S. gastrointestinal centers. 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 acquisition is subject to shareholder approval by each company¿s stockholders and certain other conditions.
¿ CytRx Corp., of Atlanta, reported publication of results from the Phase III trial of its investigational drug, CRL-5861 (purified poloxamer 188), for treatment of acute sickle cell crisis, in the Nov. 7 issue of the Journal of the American Medical Association. The national cooperative study was conducted at 40 medical centers in the U.S. and enrolled 255 patients with sickle cell disease, including 73 children under the age of 15. The study showed that purified poloxamer 188 shortened the duration of the painful crisis episodes commonly experienced by sickle cell patients.
¿ Disease Sciences Inc., of Boca Raton, Fla., agreed to acquire a majority interest in HealthSpan Sciences Inc., of San Diego, subject to closing conditions. Upon closing, HealthSpan indicated plans to change its name to Arogen Inc. Disease Sciences anticipates the closing to occur by the end of this month. HealthSpan has two patent filings with a class of compounds that may have potential as a treatment for a wide range of degenerative diseases in both humans and animals. Preliminary animal studies indicate that one of the compounds may stimulate the immune system in older animals. The company expects to begin preclinical development on these drug analogues sometime next year. Disease Sciences is developing tests for transmissible spongiform encephalopathy, scrapie in sheep, chronic wasting disease in wild deer and elk, and Creutzfeldt-Jakob disease in humans.
¿ 5 Starliving Online Inc., of South Pasadena, Calif., said it will change its name to Viral Genetics Inc., effective Nov. 20.
¿ Genencor International Inc., of Rochester, N.Y., signed a five-year worldwide supply contract with Procter & Gamble Co., of Cincinnati, to provide protease enzymes for laundry and dish detergents. The agreement, estimated to be worth up to $600 million in product revenues over the life of the contract, extends the companies¿ almost two-decade-long relationship. Genencor¿s stock (NASDAQ:GCOR) gained $2.18, or 18 percent, Wednesday to close at $14.30.
¿ GenStar Therapeutics Corp., of San Diego, was awarded three Small Business Innovation Research grants totaling $1.6 million over a two-year period by the National Institutes of Health. The grants will support the company¿s clinical trials for the treatment of hemophilia A and will aid in the development of its products for the treatment of HIV/AIDS.
¿ GenVec Inc., of Gaithersburg, Md., presented the first clinical trial data for its lead oncology product candidate, TNFerade. TNFerade delivers the human tumor necrosis factor alpha gene directly to tumors, using GenVec¿s adenovector gene delivery technology. Once inside the tumor, standard radiation therapy triggers a switch known as the EGR-1 promoter, initiating the localized production of the therapeutic anticancer protein, TNF-alpha. In the study, two of seven patients showed a complete response, two more showed a partial response and three demonstrated stable disease. Results were presented at the American Society of Therapeutic Radiology and Oncology meeting in San Francisco.
¿ Immunex Corp., of Seattle, and American Home Products Corp., of Madison, N.J., said Immunex is accelerating the transfer of ownership of the manufacturing facility in West Greenwich, R.I., to on or about Jan. 1. The facility is being redesigned to produce Immunex¿s Enbrel (etanercept). Immunex said the accelerated transfer will allow it to streamline completion of validation processes and conformance runs needed to gain FDA approval, which is anticipated in the second half of next year. Pending approval of permits, Immunex expects to break ground this fall on a second cell culture manufacturing facility, the BioNext Project, at the same location.
¿ Inpharmatica Ltd., of London, and Celera Genomics Group, of Rockville, Md., entered into a joint program to develop and commercialize a new version of Inpharmatica¿s Biopendium target and drug discovery platform. The companies intend to combine their expertise in genomics discovery and identification of protein function to produce a leading target discovery resource. The new product, to be called Celera Edition Biopendium, is expected to be launched early next year and apply Inpharmatica¿s protein structure/function prediction technology to Celera¿s mammalian sequences and other public domain sequences to create a unique resource of integrated sequence, structural and functional information.
¿ Locus Discovery Inc., of Blue Bell, Pa., said it raised $12 million in the second phase of its $40 million third round of preferred stock financing. The first phase, for $28 million, was completed in September. A previous investor, Prism Venture Partners, made the major investment in the second close. Locus has raised $88 million in three financing rounds since September 1999. (See BioWorld Today, Sept. 10, 2001.)
¿ Nastech Pharmaceutical Company Inc., of Hauppage, N.Y., entered a research collaboration with the Center for Neurodegenerative Disease Research (CNDR) at the University of Pennsylvania in Philadelphia to explore the potential of its nasally administered beta-sheet breakers in inhibiting or reversing the formation of brain plaque associated with Alzheimer¿s disease. The endeavor was unveiled at the CNDR¿s Retreat on Emerging Alzheimer¿s Disease Therapies. Nastech will provide its compounds to CNDR and fund the research with the goal of determining their potential for human clinical development. Nastech will retain commercialization rights to all data generated from the research program.
¿ NeoRx Corp., of Seattle, said it met with FDA officials last week, and plans before the year¿s end to submit to the FDA for approval a protocol for a new radiation dosimetry study for STR, a targeted therapeutic, in patients with multiple myeloma. This study is aligned with the revised clinical development proposal the company has presented to the FDA. Beginning with the new dosimetry study, the company plans to resume the STR clinical development program.
¿ Paladin Labs Inc., of Montreal, reported the acquisition of the Canadian rights to Rogitine (phentolamine mesylate injection) from Novartis Pharmaceuticals Canada Inc., of Dorval, Quebec. Rogitine is an alpha-adrenoreceptor blocker and is indicated to prevent and control hypertensive episodes in patients with pheochromocytoma. The effective date of the acquisition will be Jan. 2. Terms were not disclosed. Sales of the product in Canada were C$500,000 over the past year.
¿ Pharmacyclics Inc., of Sunnyvale, Calif., reported updated Phase I trial results suggesting the potential utility of Xcytrin in treating glioblastoma multiforme, the most common primary nervous system tumor in adults. Results were presented at the American Society of Therapeutic Radiology and Oncology meeting in San Francisco.
¿ Replicon Technologies Inc., of Birmingham, Ala., was awarded a Phase II grant of more than $750,000 to develop replicons (modified viruses that seek out and destroy cancer cells) as brain tumor therapies, by the National Cancer Institute and Small Business Innovation Research program. Funding is through September 2003.
¿ Trimeris Inc., of Durham, N.C., and Hoffmann-La Roche Inc., of Nutley, N.J., reported that site selection and patient enrollment will begin in the U.S. for T20-305, an open-label study of the investigational HIV drug T-20 in combination with oral antiretrovirals that will be conducted in North America, Europe, Brazil and Australia. This study, running parallel with two ongoing, controlled Phase III trials, initially will enroll a total of 450 adults. Drug supply of T-20 for this trial will be made available across all participating countries simultaneously.
¿ SignalGene Inc., of Montreal, said its internal drug discovery program in selective estrogen receptor modulators (SERMs) reached a significant milestone in preclinical studies. In the first of a series of tests using animal models, three novel, proprietary compounds developed as SERMs were shown to have no significant uterotrophic activity at pharmacologically relevant doses. This test assesses whether compounds stimulate growth of the uterus and thereby increase the risk of uterine cancer. The compounds stimulated less uterine growth than two SERMs currently used in therapy. In addition, the SignalGene compounds showed no obvious toxicity in mice after three days.
¿ The Parker Hughes Cancer Center, of St. Paul, Minn., said its scientist, Chen Mao, crystallized the Bruton¿s tyrosine kinase and determined the exact coordinates of its active site to a 2.1 Angstrom resolution, a discovery being reported in this week¿s Journal of Biological Chemistry. Bruton¿s tyrosine kinase is an enzyme that has been shown to cause chemotherapy resistance in leukemia and lymphoma patients, with no drugs available to target and inactivate it because its structure and 3-dimensional makeup were not deciphered. The Parker Hughes chemistry department applied this new information to design a new anticancer drug that attacks the active site of BTK and inactivates it. The new drug is being tested in animals for safety and efficacy.
¿ Tularik Inc., of South San Francisco, said that its anti-thrombotic research collaboration with Eli Lilly and Co., of Indianapolis, progressed to an advanced stage of preclinical development, triggering an undisclosed milestone payment to Tularik. As part of the July 2001 acquisition of the computer-aided molecular design (CAMD) unit of Protherics plc, Tularik inherited all existing CAMD research agreements, including the anti-thrombotic research collaboration with Lilly. The multiyear collaboration was established to design and optimize inhibitors of Factor Xa using Tularik¿s CAMD technology, as well as to investigate other potential anti-thrombotic targets. Tularik is entitled to additional payments for Factor Xa inhibitors as they progress through clinical trials to registration.