AaiPharma Inc., of Wilmington, N.C., said it and some of its officers were named as defendants in a shareholder class-action lawsuit alleging violations of federal securities law. The suit alleges that the violations took place between July 23, 2003, and Feb. 4, 2004. AaiPharma said it intends to defend itself, calling the claims without merit. The company was involved in a bidding war for CIMA Labs Inc., of Eden Prairie, Minn., during the summer. (See BioWorld Today, Nov. 5, 2003.)
Acuity Pharmaceuticals, of Philadelphia, said data published in the Feb. 18, 2004, edition of Retina showed that in a primate disease model its lead product, Cand5, significantly inhibits both the blood vessel overgrowth and vascular leakage that lead to vision loss in wet age-related macular degeneration. Cand5 is a small interfering RNA that shuts down the genes that produce vascular endothelial growth factor, which stimulates blood vessel overgrowth and regulates blood vessel permeability. The data demonstrated that a single dose reduced both neovascularization and vessel leakage in a dose-dependent manner for more than five weeks.
Aeras Global TB Vaccine Foundation in Bethesda, Md., and the David Geffen School of Medicine at University of California at Los Angeles began a U.S.-based clinical trial of a live recombinant tuberculosis vaccine called rBCG30. Six volunteers were inoculated at the Center for Vaccine Development at St. Louis University in Missouri, and volunteers also are being recruited by Piedmont Medical Research Associates in Winston-Salem, N.C. The live vaccine, which uses the current vaccine called BCG (Bacille Calmette-Guerin) as a delivery vehicle, overexpresses the major protein secreted by the tuberculosis organism.
Alteris Therapeutics Inc., of Philadelphia, licensed additional rights to its lead therapeutic vaccine, ALT-110, from Duke University in Durham, N.C., and Johns Hopkins University in Baltimore. ALT-110 is a therapeutic vaccine targeting EGFRvIII, a tumor-specific splice variant of the epidermal growth factor receptor. It is being tested in a Phase I trial with partial support from the National Cancer Institute in Bethesda, Md. Both universities have taken an equity stake in Alteris as part of the agreement. Alteris previously licensed other technology rights relevant to ALT-110 from Thomas Jefferson University in Philadelphia.
Antigenics Inc., of New York, said underwriters of its recent public offering purchased 400,000 additional common shares pursuant to a partial exercise of their overallotment option. The company received about $4 million in net proceeds from the sale, and the underwriters retain the right to acquire up to 350,000 more shares to cover additional overallotments. The company priced a $52.5 million offering earlier this month. (See BioWorld Today, Feb. 4, 2004.)
Baylor University Medical Center in Houston said one of its researchers published findings in the Feb. 18, 2004, edition of the Journal of the National Cancer Institute, describing his development of a vaccine that eradicates lung cancer in some patients. John Nemunaitis evaluated 43 early and advanced-stage non-small-cell lung cancer patients who were administered GVAX every two weeks for a total of three to six vaccinations. The study found that in a small number of people who were sensitive to the approach, the cancer had yet to return. For a number of them, it has been more than three years since they received the vaccine. GVAX is being developed by Cell Genesys Inc., of South San Francisco.
Bioenvision Inc., of New York, filed an investigational new drug application to evaluate the efficacy of Modrenal (trilostane) in patients with androgen-independent prostate cancer. The Phase II open-label trial in prostate cancer is expected to enroll 43 patients, staged in two groups. Once a single positive response is seen in the first group of 18 patients, a further 25 will be enrolled. Enrollment is expected to take place over the next 12 months. The primary endpoint of the study will be the prostate-specific antigen response.
Biopure Corp., of Cambridge, Mass., and some of its officers were named as defendants in a shareholder class-action lawsuit alleging violations on behalf of investors who purchased the company's securities between March 17 and Dec. 24. The lawsuit alleges that during the class period, defendants issued a number of positive statements regarding the progress of its regulatory approval application to market Hemopure in the U.S. for patients undergoing orthopedic surgery.
Borean Pharma A/S, of Aarhus, Denmark, acquired Proteopharma ApS, also of Aarhus, which owns patents for a protein that might reduce arterial cholesterol plaque and prevent blood clots. Deal terms were not disclosed. Proteopharma focuses on developing improved versions of the naturally occurring Apolipoprotein A-I (ApoA-I), the major protein component of high-density lipoproteins (HDL). By way of a collaboration, the companies developed a trimerized ApoA-I protein, which is a single protein carrying three Apolipoprotein A-I entities. The trimerized ApoA-l protein has a threefold increased plasma half-life as compared to the naturally occurring monomeric version of ApoA-I. It also has been shown to reduce plaque size in mice arteries more effectively than the monomeric form.
Boston Life Sciences Inc., of Boston, said its collaborating scientists published findings in the current edition of Journal of Neuroscience showing that in animal studies to achieve extensive optic nerve regeneration requires activation of the intrinsic axonal-growth program in optic nerve cells, in addition to suppressing the activity of the Nogo receptor. In the study, activation of the intrinsic growth program of the optic nerve cells was achieved through the use of the company's Macrophage Factor, one of its three axonal-growth stimulators.
Bruker Daltonics Inc., of Billerica, Mass., reported the availability of autoflex II series of Maldi-Tof and high-performance Maldi-Tof/Tof mass spectrometers. The systems are now available in the company's applications laboratories and biomarker discovery centers.
CellaVision AB, of Lund, Sweden, said the CellaVisionDM96 automated digital-cell morphology system was cleared by the FDA for sale in the U.S. The system is the next generation of the company's first product, DiffMaster Octavia. The CellaVisionDM96 locates and pre-classifies blood cells by means of automatic microscopy and advanced image processing.
Compugen Ltd., of Tel Aviv, Israel, said Abbott Laboratories, of Abbott Park, Ill., extended its agreement with Compugen, under which Abbott uses Compugen's technology for the identification and prioritization of drug targets across multiple therapeutic areas. Terms of the agreement provide Abbott with several updates of Compugen's Genecarta genome, transcriptome and proteome database, which also includes an intuitive graphical user interface and flexible query tools. Financial details were not disclosed.
Elixir Pharmaceuticals Inc., of Cambridge, Mass., appointed Vaughn Kailian chairman. Previously, Kailian was president of Cor Therapeutics, vice chairman of Millennium Pharmaceuticals and a board member of the Biotechnology Industry Organization. Elixir is a genomics-based drug discovery company developing pharmaceuticals that treat and/or prevent the spectrum of diseases that accompany aging.
EPIX Medical Inc., of Cambridge, Mass., a developer of pharmaceuticals for magnetic resonance imaging, said the FDA accepted for filing its new drug application submitted for MS-325 (gadofosveset) and designated it for a standard review cycle. MS-325 binds reversibly to human serum albumin, brightening the blood for an extended period and allowing for magnetic resonance angiographic imaging of multiple vascular beds. The NDA was filed in December. (See BioWorld Today, Dec. 17, 2003.)
Genome Therapeutics Corp., of Waltham, Mass., received FDA fast-track status for Ramoplanin in the treatment of Clostridium difficile-associated diarrhea. The firm expects to announce preliminary data from a Phase II program in the coming months. Subsequently, the Phase III program is slated to commence later this year. Ramoplanin, an antibiotic, also is in Phase III development for prevention of vancomycin-resistant enterococci bloodstream infections.
Hemispherx Biopharma Inc., of Philadelphia, said Fujisawa Deutschland GmbH, a subsidiary of Fujisawa Pharmaceutical Co. Ltd., of Osaka, Japan, entered an option agreement with the intent of becoming a distributor for Ampligen, Hemispherx's potential treatment of chronic fatigue syndrome in Germany, Switzerland and Austria. An option fee of $512,480 has been paid pursuant to the terms of the option agreement. Fujisawa also will pay several additional milestone payments, which could result in a multimillion-dollar payment to Hemispherx. On Jan. 30, Hemispherx said it completed the placebo-controlled dosage stage of the Phase III trial for chronic fatigue syndrome. Clinical data are expected to be presented at peer-reviewed scientific meetings in the second quarter.
Introgen Therapeutics Inc., of Austin, Texas, said three abstracts evaluating the role of mda-7/IL-24, the active ingredient in its INGN 241, in models of lung and breast cancer were presented at the 65th annual meeting of the Society of University Surgeons. Data from a Phase I/II trial of INGN 241 indicated that the therapy demonstrated activity in several cancer indications. The company said that due to the multifunctional activity of the ingredient, which acts as a tumor suppressor, an inhibitor of angiogenesis and an immunostimulating cytokine, INGN 241 might have utility as a monotherapy or as a component of combination regimens in a variety of cancer indications.
Lorus Therapeutics Inc., of Toronto, was approved for trading on the American Stock Exchange under the symbol "LRP," subject to fulfillment of certain conditions. Trading is expected to begin on Monday. Lorus is focused on the research and development of cancer therapies.
Medicure Inc., of Winnipeg, Manitoba, said its common shares began trading on the American Stock Exchange under the ticker symbol "MCU." Medicure is a cardiovascular drug discovery and development company.
Navidec Inc., of Greenwood Village, Colo., said Entropin Inc., of Indio, Calif., raised $3.85 million after completing a stock offering. Navidec provided Entropin with investor relations planning and consulting services, while InvestLinc Securities LLC, of Chicago, acted as the offering's placement agent. Entropin is developing compounds to treat pain.
Northwest Biotherapeutics Inc., of Bothell, Wash., accepted the resignation of Daniel Wilds, who previously held the positions of chairman and CEO and also resigned as a board member. Wilds originally stepped down as president and an employee of the company in May in order to help conserve cash, though he remained with Northwest Biotherapeutics in the position of a non-employee chairman and CEO.
Oragenics Inc., of Alachua, Fla., broke ground on a new headquarters building in a corporate office park in Alachua, becoming the first graduate of the University of Florida's Sid Martin Biotechnology Incubator to build in the park. The publicly held company is developing an antibiotic with broad-spectrum activity against Gram-positive bacteria, as well as an oral rinse for the prevention of tooth decay and a probiotic product aimed at maintaining oral health.
Origen Therapeutics Inc., of Burlingame, Calif., received a one-year Phase I Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health in Bethesda, Md. The grant supports research aimed at generating human polyclonal antibodies in chicken eggs for use as passive immunotherapy to combat the growth and infection of pathogens or to block the action of toxins. The grant provides $340,000 of research funding, and is convertible on the achievement of certain milestones to a potentially $6 million Phase II grant that would provide $2 million per year for three years.
Pharsight Corp., of Mountain View, Calif., said that Wyeth, of Madison, N.J., selected Pharsight's Knowledgebase Suite of software products for its enterprise pharmacokinetic data management and analysis solution. Pharsight will work with Wyeth to implement the Pharsight Knowledgebase Server, PKS Reporter and PK Automation Services into its drug development process at various Wyeth locations.
Prana Biotechnology Ltd., of Melbourne, Australia, was awarded a government grant worth A$1.4 million (US$1.1 million) to take PBT-2, its second-generation Alzheimer's disease drug candidate, through safety testing and Phase I trials. More specifically, Prana will use the grant to fund ongoing toxicology testing and early human trials scheduled to begin late this year.
Predix Pharmaceuticals Inc., of Woburn, Mass., began a Phase I trial of PRX-00023, its drug based on computer-generated GPCR models and optimized with integrated computational-medicinal chemistry. The compound is a dual-action serotonin 1A (5HT1A) receptor agonist/sigma-1 antagonist intended to treat anxiety, attention deficit hyperactivity and other neuropsychiatric disorders. The single dose-escalation study, which will include more than 40 healthy volunteers, is designed to evaluate the compound's safety, tolerability, pharmacokinetics and pharmacodynamics, with results expected by the first half of the year. A multiple-dose study in healthy volunteers could begin in the next quarter.
Procyon Biopharma Inc., of Montreal, reported additional positive results from an ongoing, UK-based Phase IIa trial of PCK3145, its therapeutic peptide metastatic hormone-refractory prostate cancer product. The new data from the third cohort confirms PCK3145's safety profile as well as potential therapeutic effect on the reduction of metastasis as suggested by the results of the first two cohorts released in September. Results from 12 patients to date confirm prostate-specific antigen reduction or stabilization in nine of them, and reduction or normalization of plasma MMP-9 (matrix metalloproteinase 9, an enzyme involved in tumor invasion) in all patients.
SciClone Pharmaceuticals Inc., of San Mateo, Calif., reported positive data from a pilot clinical trial in hepatitis C patients who have not responded to previous therapy. Forty-one percent of the non-responder patients tested HCV/RNA negative and 50 percent showed a virologic response after 24 weeks of a new triple therapy of Zadaxin in combination with pegylated interferon-alpha and ribavirin. By comparison, separate recent studies show that after 24 weeks of double therapy with pegylated interferon-alpha plus ribavirin, about 30 percent of hepatitis C non-responder patients tested HCV/RNA negative.
Sucampo Pharmaceuticals Inc., of Bethesda, Md., said the second of three Phase III safety trials duplicated the positive results of its first Phase III study that demonstrated long-term safety and sustained effectiveness in treating constipation with SPI-0211. The 48-week, open-label study enrolled 299 patients to support a new drug application. The company said the data confirmed safety and effectiveness in both short- and long-term treatment, without tolerability or loss of effectiveness issues. SPI-0211 activates specific chloride channels on cells lining the gut, thus increasing intestinal fluid secretion that softens a stool, facilitates intestinal motility and promotes bowel movements.
Tercica Inc., of South San Francisco, lowered the price range of its initial public offering to $11 to $13 from $14 to $16. At the same time, the company increased the number of shares to be offered to 5.5 million, up from 5 million, and added two new underwriters - Harris Nesbitt Gerard and SG Cowen Securities Corp. Tercica removed Morgan Stanley Dean Witter & Co. and Pacific Growth Equities Inc. as underwriters. The company, which is developing therapies for endocrine disorders such as diabetes and human growth diseases, postponed its IPO in November due to market conditions. (See BioWorld Today, Sept. 15, 2003.)
Viragen Inc., of Plantation, Fla., initiated its Multiferon marketing and sales program in Mexico with the natural human alpha-interferon drug being shipped to its distributor, Laboratorios Pisa. As part of the product's launch, a presentation was made on Saturday at the Mexican National Oncology Congress in Veracruz that discussed Multiferon as an adjuvant treatment for malignant melanoma.
Xcyte Therapies Inc., of Seattle, added two new underwriters to in its initial public offering registration - RBC Capital Markets and JMP Securities. The company, which pulled UBS Investment Bank as an underwriter, is developing a T-cell product for use against cancer, autoimmune disorders and infectious diseases. Xcyte filed for its IPO in October. (See BioWorld Today, Oct. 14, 2003.)