• Athelas Ltd., of Geneva, said it secured CHF2 million (US$1.36 million) in first-round financing. The company, a spin-off from the University of Geneva School of Medicine, was formed in April to develop antibacterial products based on technology that uses a cell-based approach to anti-virulence drug discovery by first evaluating candidates in cellular models, then optimizing safety and efficacy. Arvasis led the financing that included Novartis Venture Fund and Venture Incubator.

• Aton Pharma Inc., of Tarrytown, N.Y., reported results from the oral Phase I trial on SAHA, an inhibitor of histone deacetylase, which were presented at the Molecular Targets and Cancer Therapeutics conference in Frankfurt, Germany. Aton is conducting the trial in patients with refractory solid tumors, lymphomas and leukemias in collaboration with investigators at Memorial Sloan-Kettering Cancer Center. Aton said that while the study is still open, it demonstrated that the oral formulation is readily bioavailable and results in prolongation of acetylated histone accumulation in peripheral blood mononuclear cells compared to an identical dose administered intravenously. Evidence of antitumor activity also was observed, the company said.

• AVI BioPharma Inc., of Portland, Ore., said its Neugene antisense drug (AVI-4126) proved safe in adult patients with autosomal dominant polycystic kidney disease. The Phase Ib trial represented the first time Neugene was given to adult patients with substantial impairment of kidney function. The study showed that significant renal impairment in trial participants did not impact substantially how patients distributed and cleared Neugene from the body. The primary purpose of the study was to compare the way the drug is distributed in, and cleared from, the blood in PKD patients compared to normal healthy volunteers. A second important objective was to determine the safety of the drug in the clinical setting.

• BZL Biologics LLC, of Framingham, Mass., reported that its development partner, Millennium Pharmaceuticals Inc., of Cambridge, Mass., initiated a Phase I trial of MLN2704 in patients with metastatic androgen-independent prostate cancer. MLN2704 is designed to deliver chemotherapy directly to prostate tumor cells while minimizing harm to healthy cells. The primary objectives of the open-label, dose-escalation study are to determine the dose-limiting toxicity, the maximum tolerated dose and pharmacokinetic properties of MLN2704, which was developed by Millennium. The agent combines the cytotoxic agent DM1 with a monoclonal antibody, MLN591, which binds to a specific protein on the surface of prostate cancer cells called prostate-specific antigen.

• Celgene Corp., of Warren, N.J., presented data at the Symposium on Molecular Targets and Cancer Therapeutics, sponsored by the European Organization for Research and Treatment, American Association for Cancer Research and the National Cancer Institute. Celgene said its small-molecule p27 ligase modulator promoted apoptosis and inhibits tumorigenesis in several preclinical models of cancer.

• Cell Therapeutics Inc., of Seattle, presented preliminary cellular and animal model data on a cancer target, LPAAT-beta, a lipid-regulating enzyme, in a plenary session at the International Conference on Molecular Cancer Targets in Frankfurt, Germany. CTI scientists have shown that it is highly expressed in cancers of the lung, ovary, prostate, bladder and cervix while it is minimally expressed in most normal tissues. They also have shown that inhibiting LPAAT-beta kills cancer cells. When using a genetic silencing technique known as RNAi to decrease LPAAT-beta expression, the AKT pathway is interrupted, which blocks cell proliferation and leads to tumor cell death. CTI is developing drugs to inhibit LPAAT-beta. Separately, Cell Therapeutics reported that PanGenex, its majority-owned subsidiary, presented data on its gene knockout and transcription reporter technologies in a poster session at the conference. The preclinical data outlined a process that is designed to enable the rapid and efficient inactivation, or knockout, of genes in human cells. In a pilot study, PanGenex used its technology to knockout vectors, allowing users to create customized arrays of knockout cells, which may then be screened to identify the most favorable gene targets suitable for drug development.

• Chronogen Inc., of Montreal, licensed from McGill University the proteins CLK-1, CLK-2, and ISP-1, as well as a series of targets. The proteins are involved in the production of reactive oxygen species that can cause cell damage, the company said. Financial terms were not disclosed.

• Commonwealth Biotechnologies Inc., of Richmond, Va., said it has met the requirements for Nasdaq's minimum market value rule. The company was notified on Aug. 16 that it might be delisted. The company provides research and development services to entities involved in biotechnology.

• ConjuChem Inc., of Montreal, said Jacques Lapointe has been named chairman of the board, as well as chairman of the executive committee. Most recently, Lapointe served as president, chief operating officer and director of Biochem Pharma Inc. Prior to that, he worked for 12 years with Glaxo Wellcome plc, of London. Prior to Glaxo Wellcome, Lapointe spent 17 years with Johnson & Johnson.

• Connetics Corp., of Palo Alto, Calif., received the final milestone payment from Pharmacia Corp., of Peapack, N.J., after the successful completion of a predetermined milestone with minoxidil foam. In January, Connetics reported a licensing agreement granting Pharmacia Corp. exclusive global rights, excluding Japan, to Connetics' foam drug-delivery technology for use with Pharmacia's Rogaine hair loss treatment.

• Elixir Pharmaceuticals Inc., of Cambridge, Mass., a genomics-based drug discovery company developing drugs that slow aging and delay the onset of age-related diseases, and Evotec OAI AG, of Hamburg, Germany, signed a three-year agreement under which Evotec will provide Elixir with a range of chemical and biological drug discovery and development services. Elixir's relationship with Evotec OAI will be governed by a broader, three-year agreement between Oxford Bioscience Partners, of Abingdon, UK, with Evotec to supply chemistry and biology services to OBP portfolio companies.

• Endovasc Ltd. Inc., of Montgomery, Texas, formed Stentgenix Inc., a 50-50 joint venture company. Stentgenix will be funded by MIV Therapeutics Inc., of Vancouver, British Columbia, which agreed to invest $2.5 million over the next three years. Stentgenix will focus on developing Endovasc's Angiogenix in a pharmaceutical coating block to block restenosis while stimulating angiogenesis for coronary and peripheral stents. Stentgenix also will develop Endovasc's next generation of biodegradable/resorbable stent and catheter accessory technologies.

• EntreMed Inc., of Rockville, Md., requested that the U.S. District Court for the District of Columbia dismiss a lawsuit filed by Celgene Corp., of Warren, N.J., against the U.S. Patent and Trademark Office and EntreMed to block the issuance of patent applications protecting EntreMed's ENMD 0995, a thalidomide analogue. Also, EntreMed filed its own lawsuit against Celgene in the United States District Court in the Southern District of Maryland, asking that the court declare three of Celgene's patents invalid, find that Celgene has violated U.S. antitrust laws and award EntreMed unspecified damages. ENMD 0995 entered Phase I trials last week.

• ESBAtech AG, of Zurich, Switzerland, said it closed on CHF4 million more in its second round of financing, bringing the total of the round to CHF14.5 million (US$9.9 million). Investors in the new closing were Innoventure Capital AG (Credit Suisse) and Venture Incubator AG. The company, which specializes in preclinical research comprising the identification of disease-relevant genes and functional screenings for lead compounds in cell-based assays, said the money should last until at least mid-2004.

• Exhale Therapeutics Inc., of Belmont, Calif., initiated Phase I trials of ETX-100 for the treatment of genetic emphysema associated with alpha-1 antitrypsin deficiency. Exhale also said its investigational new drug application to the FDA is in effect. AAT deficiency is a common heritable pulmonary disorder that can result in life-threatening emphysema in adults.

• Genentech Inc., of San Francisco, reported results from the Assent 3 Plus trial that demonstrated pre-hospital administration of the single-bolus thrombolytic agent TNKase (tenecteplase) to patients suffering from acute myocardial infarction to be technically feasible and faster than in-hospital treatment. The results were reported at the American Heart Association meeting in Chicago. Administration of clot-dissolving agents in the pre-hospital setting was shown to accelerate the treatment of heart attack patients by an average of more than 40 minutes. The multicenter, randomized, open-label study involved 1,639 patients.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, reported positive results from a Phase II trial of a buccal formulation of HE2000, its lead immune-regulating hormone, in malaria patients. The company also reported that in preclinical studies of tuberculosis, HE2000 dramatically decreased the number of tuberculosis bacteria present in the lungs and significantly reduced the loss of functional lung tissue when compared to control animals. Overall, 20 of the 21 patients treated reached the primary endpoint of the trial (50 percent reduction of parasites), and 15 of 21 patients cleared the parasites from the blood within seven days of treatment.

• Inhale Therapeutic Systems Inc., of San Carlos, Calif., said Somavert, developed by Pharmacia Corp., of Peapack, N.J., was approved in Europe. Somavert, which uses Inhale's PEGylation technology, has been approved for the treatment of certain patients with acromegaly. Somavert is the fifth product using Inhale's technology that has been approved for marketing in Europe.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., initiated a Phase II trial of alicaforsen (ISIS 2302), an antisense inhibitor of intercellular adhesion molecule-1, in people with ulcerative colitis. The study will compare the safety and efficacy of an enema formulation of alicaforsen to mesalamine enema, a widely used medication for the disease. The randomized, double-masked, active-controlled study is planned to enroll about 170 patients at 25 U.S. sites. An intravenous formulation of alicaforsen is being evaluated in a Phase III program in people with Crohn's disease.

• Ligand Pharmaceuticals Inc., of San Diego, priced a private placement of $135 million of its 6 percent convertible subordinated notes due Nov. 16, 2007. The offering is expected to close Nov. 26. The notes are convertible into shares of Ligand common stock at $6.17 per share, a 22 percent premium to the closing bid price of $5.06 on November 20. Ligand also granted the initial purchaser an option to acquire, within 30 days, an additional $20.25 million of notes. Ligand said it intends to use the net proceeds of the offering to fund the restructuring of its Avinza relationship with Elan Corp. plc, of Dublin, Ireland; to repurchase shares of the company's common stock from Elan and to acquire government securities that Ligand is required to pledge as security for the notes for the first two years. Ligand also plans to use the proceeds for general corporate purposes. (See BioWorld Today, Nov. 14, 2002.)

• Morphochem AG, of Munich, Germany, entered an agreement with AstraZeneca AB, of Sweden, wherein Morphochem will apply its MOREsystem technology to the discovery of compounds with activity against an undisclosed novel target in the area of thrombolytic disorders. Morphochem will apply its evolutionary discovery approach that uses multicomponent reaction chemistry along with software based on genetic algorithms. AstraZeneca will fund the research. Additional details were not disclosed.

• NeoPharm Inc., of Lake Forest, Ill., said it terminated its Feb. 19, 1999, license agreement with Pharmacia Corp., of Peapack, N.J., for what NeoPharm said was Pharmacia's failure to use commercially reasonable efforts in the development programs from LEP (liposome-encapsulated paclitaxel) and LED (liposome-encapsulated doxorubicin). NeoPharm filed for arbitration in April following a Pharmacia spokesman's claim that LEP failed to show benefit in studies run by Pharmacia. (See BioWorld Today, April 24, 2002.)

• NeoTherapeutics Inc., of Irvine, Calif., said it issued 356,926 shares of common stock in a private placement to five vendors as payment for $628,190.09 in payables. NeoTherapeutics develops in-licensed drugs for the treatment and supportive care of cancer patients.

• Northwest Biotherapeutics Inc., of Bothell, Wash., received notice from the Nasdaq National Market that its common stock no longer meets the requirements for listing. Pursuant to Marketplace Rule 4450(a)(2), the company must maintain a public float of at least $5 million. In a letter dated Nov. 19, Nasdaq said its common stock failed to meet that requirement for the past 30 consecutive trading days. The company has until Feb. 17 to demonstrate compliance for at least 10 consecutive trading days.

• Oxford GlycoSciences plc, of Oxford, UK, said it received feedback from FDA concerning Zavesca, in which the FDA said it believes that management of benefit/risk ratio can be achieved through restricted use of the drug. Oxford said it intends to submit an amendment to the new drug application for Zavesca early next year. OGS submitted an NDA for Zavesca for the treatment of patients with Type I Gaucher's disease in August 2001. In June, the FDA issued a complete response letter indicating that the product was not approvable based on the FDA's opinion that OGS had not provided sufficient support of safety and efficacy of the drug. The product is approved in Europe. (See BioWorld Today, June 25, 2002, and July 29, 2002.)

• Pharsight Corp., of Mountain View, Calif., is implementing a restructuring plan in connection with its decision to continue to focus its efforts on its core businesses of software and consulting services for pharmaceutical and biotechnology companies. The plan reduces resources not integral to the software products and consulting services. The company will cut 20 percent of employees and is expected to reduce annualized operating expenses of $2 million to $2.5 million. The company expects to record a restructuring charge of about $200,000 in the fourth quarter.

• Serenex Inc., of Durham, N.C., said that Richard Kent was appointed president and CEO of the drug discovery company. Kent is a former executive at London-based GlaxoSmithKline plc. Most recently, Kent served as president and CEO of Ardent Pharmaceuticals Inc., a Durham-based start-up focused on the discovery and development of delta receptor compounds.

• Teva Neuroscience Inc., of Kansas City, Mo., said European researchers uncovered new evidence that Copaxone (glatiramer acetate injection) not only reduces relapse rate in relapsing-remitting multiple sclerosis but also encourages the release of a factor that helps protect the brain from axonal loss. The study, published in the November 2002 issue of Brain, showed that Copaxone stimulates T cells to produce the neuroprotection factor BDNF (brain-derived neurotrophic factor) in tissue culture using T cells from a Copaxone patient. Copaxone is indicated for the reduction of frequency of relapses in relapsing-remitting MS.

The PSMA Development Company LLC, a joint venture of Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., and Cytogen Corp., of Princeton, N.J., reported that a PSMA antibody substantially reduced tumor growth in an animal model of human prostate cancer. Administration of single doses of a radio-labeled, fully human monoclonal antibody arrested tumor growth for more than two weeks, the companies said. The findings were scheduled to be presented today at the Molecular Targets and Cancer Therapeutics annual conference in Frankfurt, Germany. Progenics' stock (NASDAQ:PGNX) gained $1.20 Thursday, or 17.2 percent, to close at $8.16.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., said results of the SOLO trial, an open-label, multicenter study evaluating the safety and efficacy of once-a-day dosing of the investigational protease inhibitor GW433908 boosted with ritonavir in antiretroviral therapy-na ve patients vs. twice-a-day nelfinavir, were presented at the 6th International Congress on Drug Therapy in HIV infection in Glasgow, UK. SOLO is one of the first pivotal studies to investigate the potential of once-a-day dosing of an HIV protease inhibitor. In the final analysis of the 48-week trial data, 68 percent of HIV-positive patients achieved undetectable viral load with 908/r compared to 65 percent of patients taking NFV twice a day. The '908 compound was co-discovered by GlaxoSmithKline plc, of London.