• Acacia Research Corp., of Newport Beach, Calif., said Gregory Verdine, a Harvard college professor and Erving professor of chemistry in Harvard's department of chemistry and chemical biology, will use the CombiMatrix Group's arrays to map three-dimensional binding sites for oligonucleotides on folded RNA molecules. The research program is designed to discover discontinuous RNA epitopes that will serve as therapeutic targets for drug interventions. The program might enable the discovery of new drugs and approaches to modulate the operation of RNA molecules in cells.

• Acuity Pharmaceuticals, of Philadelphia, presented top-line results from a recently completed study of its lead siRNA therapeutic, Cand5, in a validated primate model of age-related macular degeneration. The research represents the first demonstration of the clinical efficacy of a small interfering RNA therapeutic in a validated large animal model of disease. Cand5 significantly reduced the neovascularization that lead to vision loss in macular degeneration by shutting down the production of vascular endothelial growth factor. Results were presented at the Knowledge Foundation's Third Annual conference in San Diego.

• Aderis Pharmaceuticals Inc., of Hopkington, Mass., withdrew its initial public offering due to market conditions. Aderis filed for an IPO in January 2002 as well, but pulled it the following August. The company, which had proposed to sell 6.5 million shares at a price range of $9 to $13, postponed the offering two weeks ago. (See BioWorld Today, Oct. 30, 2003.)

• Advanced Viral Research Corp., of Yonkers, N.Y., said preliminary results from the first 15 cachectic AIDS patients treated with the company's immunomodulator AVR118 showed improvement in appetite, weight gain or stability, and enhanced quality of life in all the patients. None of the 15 patients reported any significant side effects from AVR118 (formerly known as Product R) therapy. Cachexia is a state of body malnutrition and wasting with loss of body fat and lean body weight.

• Alchemia Ltd., of Brisbane, Australia, filed a prospectus for an A$21 million (US$15 million) follow-on public offering and to seek a listing on the Australian Stock Exchange. The company plans to issue 30 million shares at A70 cents each, increasing its total shares outstanding to 100 million. The offer is jointly underwritten by Credit Suisse First Boston Australia Ltd. and ABM AMRO Morgans Corp. Ltd. The offering is expected to open on Nov. 17 and close on Dec. 12. Alchemia uses its carbohydrate synthesis technology to manufacture and discover carbohydrate-based drugs.

• Cellegy Pharmaceuticals Inc., of South San Francisco, appointed Richard Williams chairman, assuming that responsibility from Michael Forrest, who will retain his positions of president and CEO and remain a board member. Williams is president and founder of Conner-Thoele Ltd., a consulting and financial advisory firm specializing in health care acquisition analysis. Cellegy is engaged in the development of drugs for the treatment of gastroenterology disorders, sexual dysfunction and nitric oxide donors for the treatment of certain cancers.

• Cepheid Inc., of Sunnyvale, Calif., said SF Capital Partners Ltd., the institutional investor who participated in Cepheid's $10 million common stock offering completed in August, exercised its option to purchase 555,556 additional shares generating proceeds of about $2 million. The purchase was part of a one-time option. UBS securities LLC acted as Cepheid's financial advisor for the offering.

• Chiron Corp., of Emeryville, Calif., said it granted a nonexclusive license to Vertex Pharmaceuticals Inc., of Cambridge, Mass., for the research, development and commercialization of therapeutics against certain hepatitis C virus drug targets. Chiron was granted limited rights to review Vertex's compound VX-950, a potential treatment for HCV infection, for potential licensing. Financial terms and other details of the license were not disclosed.

• Ciphergen Biosystems Inc., of Fremont, Calif., disclosed the discovery of a novel biomarker pattern for potential diagnostic use that correctly classified more than 96 percent of Alzheimer's disease individuals and more than 94 percent of normal individuals using a four-peak pattern of markers. Results were presented at the Society for Neuroscience 33rd annual meeting in New Orleans. The research used Ciphergen's SELDI ProteinChip Biomarker System and patented Expression Difference Mapping methodology.

• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., settled all pending litigations with West-ward Pharmaceutical Corp., of Eatontown, N.J. CollaGenex alleged that West-ward infringed its patents for Periostat for adult periodontitis, and that West-ward infringed its patent rights under the Hatch-Waxman act by filing an application with the FDA to market a generic capsule version of Periostat. CollaGenex's stock (NASDAQ:CGPI) gained $1.58 Monday, or 17.06 percent, to close at $10.84.

• Dendreon Corp., of Seattle, presented data from a Phase III trial (study D9901) of Provenge in androgen independent prostate cancer at the Prostate Cancer Foundation 10th annual scientific retreat in New York. The data show a median survival time of 26.3 months for patients treated with Provenge, compared to 19.3 months for patients receiving placebo. Extended survival of 4.6 months was noted among patients who initially received placebo, experienced disease progression and subsequently were treated with active therapy in a crossover protocol. Previously reported data from the trial showed significant clinical benefit from Provenge treatment for men with a Gleason Score of 7 or less. The company said that for these men, the probability of remaining progression-free while in the study was more than two times higher than for patients treated with placebo (p=0.001), and the probability of remaining free of cancer-related pain while in the study was more than two-and-one-half times higher than for patients receiving placebo (p=0.016). (See BioWorld Today, July 16, 2003.)

• Dharmacon Inc., of Lafayette, Colo., entered an agreement to supply custom siRNA reagents to Bayer AG, of Leverkusen, Germany. The siRNA reagents supplied to Bayer will be designed using Dharmacon's SMARTselection and SMARTpool technologies and will be used by Bayer to accelerate the company's target validation and basic drug development research. Dharmacon's technologies are designed to create specific gene-silencing agents that can accelerate investigations across a range of biomedical and biological research.

• Diversa Corp., of San Diego, and the San Diego Zoo entered a collaboration that might increase knowledge of microorganisms that live in and around endangered species. Researchers from Diversa will work with the zoo's Center for Reproduction of Endangered Species to collect samples of microbial communities from endangered species at the zoo. Using Diversa's technology, the samples will be analyzed and compared to similar samples taken from wild habitats and species.

• Echelon Biosciences Inc., of Salt Lake City, is offering five new anti-phosphoinositide antibodies. The company, which also internally is developing one such mouse monoclonal IgG, said they all primarily recognize the head group of their cognate phosphoinositide and show low cross-reactivity with other phosphoinositides or phospholipids, depending on the assay format.

• Elusys Therapeutics Inc., of Pine Brook, N.J., entered an agreement with the University of Pennsylvania to further develop a thrombolytic technology developed by the school. Elusys will apply its Heteropolymer technology, which binds thrombolytics such as plasminogen activators, tPA and urokinase to red blood cells, to validate the university's technique in a clinical setting.

• Emisphere Technologies Inc., of Tarrytown, N.Y., presented results from a Phase I study evaluating an oral insulin tablet prototype (the Emisphere oral insulin tablet) at the Diabetes Technology Society's 3rd annual meeting, held in San Francisco. The study was designed to test the performance of insulin tablet prototypes prepared with an Emisphere delivery agent when orally administered to Type II diabetic patients who subsequently either fasted or were fed a standard meal. In addition to safety and tolerability, blood glucose, insulin and C-Peptide levels were monitored. The study demonstrated that an oral insulin prototype could be dosed very close to mealtime.

• Fulcrum Pharmaceuticals LLC, of Larchmont, N.Y., reported that, jointly with Ernesto Freire, professor of biology at Johns Hopkins University, and members of his laboratory, they have designed and tested a number of new compounds that inhibit an enzyme critical to the viability of the severe acute respiratory syndrome virus. After the genetic sequence of the SARS virus was published, Freire's team was able to clone the protease enzyme in order to test the activity of the designed inhibitors.

• Gene Logic Inc., of Gaithersburg, Md., and Genetraks Pty. Ltd., an Australia-based venture-funded firm, entered an agreement to develop a custom equine gene expression data resource. Gene Logic will build Genetraks a database of genomic content from equine samples and related clinical information using custom microarrays provided by Genetraks. Genetraks intends to use the gene expression reference dataset in developing diagnostics and performance monitoring technologies to expand the understanding of states of normal and diseased equine biology. Financial terms were not disclosed.

• Hemispherx Biopharma Inc., of Philadelphia, reported data showing that Alferon, the company's lead drug, is active against severe acute respiratory syndrome coronavirus. Alferon inhibits SARS-CoV at a high specific activity in Vero 76 cells in culture. Inhibition was quantitated by visual cytopathic effect (CPE); inhibition of the cellular uptake of the vital dye, neutral red; and by virus yield reduction. Fifty percent effective doses were calculated for both CPE and NR assays by regression analysis. Quantitative values for viral yield reduction assays were expressed as 90 percent effective concentrations, representing the drug concentration required to reduce SARS-CoV titers by one log10 and were calculated by regression analysis. Vero cells infected at a MOI of 0.001 visually exhibited 100 percent CPE over a three- to five-day period.

• Immtech International Inc., of Vernon Hills, Ill., reported that its board approved a two-for-one stock split of its common stock. Immtech said it intends to present the stock split proposal to its stockholders for approval at its 2003 annual meeting. If approved, each holder of common stock would receive one additional share for each share of common stock held. Concurrently, the conversion rate of outstanding convertible securities such as preferred stock, options and warrants would be proportionately increased and the exercise prices of options and warrants would be proportionately reduced. Immtech is focused on the commercialization of oral treatments for infectious diseases.

• Incara Pharmaceuticals Corp., of Research Triangle Park, N.C., said the FDA granted orphan drug designation to its drug candidate for the treatment of amyotrophic lateral sclerosis. Incara's antioxidant compound, AEOL 10150, has demonstrated efficacy in an animal model of ALS and models of other neurodegenerative diseases. AEOL 10150-treated mice, in addition to surviving longer, remained only mildly disabled until a few days before death. Incara's stock (OTCBB:INCR) rose 14 cents Monday, or 45.2 percent, to close at 45 cents.

• Invitrogen Corp., of Carlsbad, Calif., said a new policy permits purchasers of its Gateway Technology Open Architecture to create and freely distribute clones within the scientific community. The product allows a method for cloning DNA sequences and moving the sequences into multiple systems for studying genes and proteins.

• IsoTis OrthoBiologics SA, of Lausanne, Switzerland, reported the listing of its common shares on the Toronto Stock Exchange, trading under the symbol "ISO," effective Nov. 12. IsoTis OrthoBiologics was created through the merger of GenSci OrthoBiologics, of Irvine, Calif., and IsoTis SA, a Swiss-Dutch biomedical company, and its facilities in Bilthoven, the Netherlands, and in Irvine, Calif. The company is developing natural demineralized bone matrix products and synthetic bone graft substitutes, carrier technologies and biologically based growth factors.

• Manhattan Pharmaceuticals Inc., of New York, raised gross proceeds of $10 million after completing a private placement of 1 million shares of Series A convertible preferred stock at $10 apiece. Each share is convertible at the holder's election into common shares at $1.10 apiece, and each is automatically convertible by the company into common shares upon the occurrence of certain undisclosed events. Manhattan said the funding would allow it to further develop its lead compounds, oleoyl-estrone for obesity and propofol lingual spray for pre-procedural sedation. The private placement was completed by agents Maxim Group LLC and Paramount Capital Inc., both of New York.

• MWG Biotech AG, of Ebersberg, Germany, entered an agreement to place more than 100 automated sample processor platforms with the Diagnostics Division of Bayer HealthCare LLC, of Tarrytown, N.Y., through its Canadian affiliate Bayer Inc. and its Irish affiliate Bayer Diagnostics Europe Ltd. Bayer and MWG have been collaborating over the last eight months on an application project to allow fully automated sample preparation of Bayer's Versant HIV and HCV (bDNA) viral load assays on MWG's automated sample processor.

The National Psoriasis Foundation in Portland, Ore., said researchers using data gleaned from a tissue bank it created have identified three of the first genes associated with psoriasis. Anne Bowcock of Washington University in St. Louis and her colleagues identified three genes on chromosome 17 in which the "on and off" switches are impaired in statistically significant numbers of psoriasis patients. Several other psoriasis susceptibility genes are expected to be identified in the months and years ahead, including one on chromosome 6. In all, it is suspected that more than a dozen genes are involved in psoriasis. The finding is published in the December 2003 issue of Nature Genetics.

• Neurocrine Biosciences Inc., of San Diego, said results from its Phase I trial of immediate-release indiplon showed that elderly subjects given 5-mg or 10-mg doses in the middle of the night did not experience next-morning residual effects compared to placebo, using standard measurements of psychomotor function and alertness. The four-way, crossover, randomized study also showed that patients who received zopiclone 3.75 mg, the approved European starting dose for elderly insomnia patients, experienced significant impairment the next morning, as compared with placebo.

• Novuspharma SpA, of Milan, Italy, said it would report preliminary Phase I results at next month's American Society of Hematology meeting in San Diego showing that use of Pixantrone (BBR 2778) as a variant of the CHOP regimen results in an overall response rate of more than 80 percent in elderly multi-relapsed patients. The data, which are available at www.hematology.org, revealed six complete responses (38 percent) and seven partial responses (44 percent) out of 16 evaluable patients. They were achieved in patients with a mean age of 66 and who had relapsed multiple times from prior chemotherapy treatment (median number of prior regimens 2; range 1-7). Updated data on more than 22 patients will be presented at the meeting.

• OSI Pharmaceuticals Inc., of Melville, N.Y., started a Phase II dose-escalation study of Tarceva (erlotinib) in patients with advanced non-small-cell lung cancer who failed prior chemotherapy. Tarceva, OSI's leading drug candidate, is designed to block tumor cell growth by inhibiting the tyrosine kinase activity of the HER1/EGFR receptor, thereby blocking the HER1/EGFR signaling pathway inside the cell. Tarceva is being developed in a three-way deal involving OSI; Genentech Inc., of South San Francisco; and Roche Holdings Inc., of Basel, Switzerland.

• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., and Cytogen Corp., of Princeton, N.J., through their joint venture, PSMA Development Co. LLC, announced publication of new information related to antibody and vaccine therapies that target prostate-specific membrane antigen (PSMA). The findings were published in the current issue of the Proceedings of the National Academy of Sciences. PSMA serves as a target for cancer therapy by virtue of its expression on the surface of prostate cancer cells and the new blood vessels that supply most other solid tumors.

• Rubicon Genomics Inc., of Ann Arbor, Mich., launched its GenomePlex whole genome amplification (WGA) point-of-use kit applications in the research market. The kit complements Rubicon's WGA in-house service business that was launched earlier this year. Rubicon said its in vitro method to convert very small amounts of genomic DNA into OmniPlex amplifiable libraries has applications in research, pharmacogenomics, molecular diagnostics and forensics.

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., completed a private placement of 1.7 million shares of common stock on Nov. 7 to select institutional investors. Net proceeds to the company were about $29 million. The company intends to use the proceeds to pursue its strategic objectives, including the development of the products in its pipeline and the in-licensing acquisition of additional products. The company develops prescription pharmaceutical products for gastrointestinal disease.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., and Teva Pharmaceutical Industries Ltd., of Jerusalem, mutually agreed to terminate their acquisition talks due to an inability to reach an agreement on terms. In early October, Teva had expressed an interest in paying $365.3 million in cash for all of Savient's outstanding shares at about $6.14 apiece. Savient's stock (NASDAQ:SVNT) fell 81 cents, or 13.6 percent, to close at $5.17.

• Serenex Inc., of Durham, N.C., entered a research agreement to use its chemoproteomics technologies within the drug discovery program at F. Hoffmann-La Roche Ltd., of Basel, Switzerland. Roche will supply Serenex with small-molecule, drug-like compounds, and Serenex will use its Proteome Mining and Functional Proteome Fractionation technologies to screen the Roche compounds against thousands of protein targets simultaneously. Financial terms were not disclosed.

• Vasogen Inc., of Mississauga, Ontario, identified a new class of pharmaceuticals targeting chronic inflammation. The company's first drug candidate in that class, VP025, is being developed for the treatment of neuro-inflammatory conditions, with first research findings presented at the 33rd annual meeting of the Society for Neuroscience in New Orleans last weekend. The new class is based on synthetic lipid technology, which comprises phospholipid microparticles with specific surface molecular groupings.

• XenoPort Inc., of Santa Clara, Calif., reported the initiation of Phase I studies of its lead investigational drug, XP13512. A new chemical entity, XP13512 is a transported prodrug of the marketed drug gabapentin and has been designed for superior pharmacokinetics and therapeutic use. The initial Phase I study is intended to demonstrate the safety and pharmacokinetic properties of the drug.

No Comments