• AaiPharma Inc., of Wilmington, N.C., extended and amended its pending solicitation from holders of its 11 percent senior subordinated notes relating to certain proposed amendments to and waivers of the indenture governing the notes. All holders of record who submit valid and unrevoked consents prior to noon EST, today will receive the consent fee of $10 in cash per $1,000 principal amount of notes for which consents have been delivered. Holders who previously have delivered consents need not take any further action in order to receive the fee.

• Advanced Biotherapy Inc., of Woodland Hills, Calif., reported the launch of a Phase I FDA-approved trial to initially treat antiretroviral drug-resistant AIDS patients with an inhibitor to tumor necrosis factor-alpha. The study's enrollment at the outset is limited to 10 patients who are in virologic failure and are no longer able to benefit from the administration of Highly Active Anti-Retroviral Therapy (HAART). Researchers will use initially an inhibitor that targets TNF-alpha, a pro-inflammatory cytokine.

• Applied Biosystems Group, of Foster City, Calif., and Roche Molecular Systems Inc., a unit of F. Hoffmann-La Roche Ltd., of Basel, Switzerland, were awarded $19.8 million in damages by a jury following a favorable decision in a federal lawsuit. The jury found that MJ Research Inc. and its principals, Michael and John Finney, infringed patents related to polymerase chain reaction process technology and thermal cycler instrument technology. In addition to direct infringement by MJ Research of two patents, the jury found that MJ Research contributed to infringement by its customers of those two and induced its customers to infringe all the patents. Applied Biosystems and Roche Molecular are pursuing an enhancement of damages, including legal fees, since several infringements were found to be willful, as well as an injunction against MJ Research, which has filed for bankruptcy court protection.

• Ardais Corp., of Lexington, Mass., and Duke University Medical Center in Durham, N.C., established a biorepository that will provide human biomaterials and clinical data for cancer research to Duke's Breast Spore programs and to its Comprehensive Cancer Center. The biorepository is based on the biomaterials initiative begun four years ago by the two parties. It will address the biomaterial requirements of Duke researchers as they conduct clinical trials analyzing and treating cancer at the molecular level, and it may be expanded in the future to diseases outside of cancer.

• Avanir Pharmaceuticals Inc., of San Diego, presented data on its lead anti-inflammatory compounds at the Experimental Biology 2004 meeting organized by the Federation of American Societies for Experimental Biology in Washington that began Saturday and continues through Wednesday. The Avanir compounds target macrophage migration inhibitory factor (MIF), a pro-inflammatory cytokine that plays a critical role in inflammatory disorders. The company said it believes it was the first publicly presented data that demonstrate therapeutic efficacy of an orally active small-molecule MIF inhibitor in established animal disease models.

• Bayhill Therapeutics Inc., of Palo Alto, Calif., appointed Mark Schwartz president, CEO and a director. John Walker will continue as chairman. Schwartz was previously CEO of Calyx Therapeutics Inc. Bayhill Therapeutics is focused on therapeutics for autoimmune diseases targeting disease management at the underlying mechanism.

• BioCurex Inc., of Richmond, British Columbia, reported preliminary results from a study designed to validate its Histo-RECAF version 2.0. The version uses a high-affinity anti-RECAF antibody that improves the contrast between cancer cells and the surrounding non-malignant tissue. The study was commissioned by Protokinetix Inc., of Vancouver, British Columbia, which was granted a license by BioCurex to commercialize therapeutic anti-RECAF antibodies modified according to Protokinetix's Super-Antibody technology and Compeigne, France-based Perigene Inc.'s catalytic antibody technology.

• Biopure Corp., of Cambridge, Mass., filed a shelf registration statement with the SEC to sell up to $50 million worth of common stock from time to time. The company said it would use any resulting proceeds for general corporate purposes, such as capital spending and working capital. Biopure is developing Hemopure, an oxygen therapeutic.

• Callisto Pharmaceuticals Inc., of New York, raised about $4.8 million in gross proceeds after completing a private placement of about 2.2 million common shares at $2.25 each. The company, which is developing drugs for multiple myeloma, other cancers and osteolytic bone disease, said it would use a portion of the net proceeds for working capital and for clinical trials of its lead drug candidate, Atiprimod. The placement was managed by Punk Ziegel & Co.

• Cell Signaling Technology Inc., of Beverly, Mass., signed a supply and license agreement to allow Zeptosens AG, of Witterswil, Switzerland, to use and resell certain Cell Signaling reagents in conjunction with its ZeptoMARK protein microarray platform. The reagents include phosphospecific antibodies to signaling molecules and therapeutic targets such as kinases. The companies said the ZeptoMARK CeLyA (Cell Lysate Arrays) in combination with Cell Signaling's specific antibodies provide a microarray system for monitoring of protein expression and quantitative protein-activation profiling.

• Centocor Inc., of Malvern, Pa., said the FDA accepted its supplemental biologics license application for the use of Remicade (infliximab) for the treatment of ankylosing spondylitis. Remicade is an anti-tumor necrosis factor-alpha therapy and is the only biologic indicated for the treatment of both rheumatoid arthritis and Crohn's disease, Centocor said. The U.S. submission is based primarily on the results of the Assert (Ankylosing Spondylitis Study for the Evaluation of a Recombinant Infliximab Therapy) trial, which showed that patients with active ankylosing spondylitis achieved improvement in signs and symptoms associated with their disease.

• Ciphergen Biosystems Inc., of Fremont, Calif., said its wholly owned subsidiary, Ciphergen Biosystems K.K., based in Japan, was designated an official technology supplier for a Japanese project called the Drug Discovery Proteome Factory. Ciphergen sold three ProteinChip AutoBiomarker Systems and two ProteinChip Tandem MS Interfaces to the factory. The Japan Health Science Foundation formed the factory to analyze disease-related proteins as part of a five-year project, which involves a consortium of 20 pharmaceutical companies that aim to develop analytical methods in the areas of cancer, diabetes, hypertension, asthma and dementia.

• Cytogen Corp., of Princeton, N.J., and researchers at the Kimmel Cancer Institute at Thomas Jefferson University announced positive results from their collaboration to identify interactions associated with the tumor-suppressor protein Wwox. The results were published in the Proceedings of the National Academy of Sciences. A variety of in vivo experiments confirmed the functional association between Wwox and p73 using data from Cytogen's in vitro signal transduction pathway discovery platform. The study also demonstrated that the interaction results in an increased rate of cell death.

• CytRx Corp., of Los Angeles, filed a report with the SEC saying its audit committee dismissed PricewaterhouseCoopers LLP as its independent auditor and engaged BDO Seidman LLP as its new independent accountant. The company was unable to file its annual report on Form 10-K by an extended deadline due to pending accounting treatment issues and the company's change of accountants. The matters related to the July 2002 merger with Global Genomics Capital Inc., of Los Angeles, and the subsequent investment in Blizzard Genomics Inc., of Minneapolis. The company believes its prior accounting treatment for those items was correct. The final resolution of the issues will have no effect on the company's cash or working capital position or on its net worth as of Dec. 31, it said.

• Discovery Partners International Inc., of San Diego, entered a drug discovery chemistry agreement with Vertex Pharmaceuticals Inc., of Cambridge, Mass. Discovery Partners will use its knowledge of focused library synthesis and medicinal chemistry to complement and assist Vertex in advancing drug discovery for one of its research programs. Financial terms were not disclosed.

• Echelon Biosciences Inc., of Salt Lake City, initiated a collaboration with Gordon Mills of the University of Texas M.D. Anderson Cancer Center to advance cell-signaling cancer therapeutics. Mills and Echelon will work to progress drug candidates through preclinical testing and into the clinic. Echelon has identified oncology targets, including PI 3 kinase, in the area of Mills' research, which is directed at identifying the molecular mechanisms by which normal and cancer cells perceive and respond to their environment.

• Forbes Medi-Tech Inc., of Vancouver, British Columbia, reported data from its Phase II European trial of its cholesterol-lowering compound, FM-VP4, demonstrating a statistically significant dose response with 400 mg/day (p<0.007). The company noted that further studies are required to confirm such a plateau. Forbes added that the time response to FM-VP4 indicated that LDL cholesterol levels might continue to decrease when given to patients for longer than four weeks, the duration of the completed trial, and that optimal efficacy may not have been achieved.

• Genentech Inc., of South San Francisco, said its stockholders authorized an increase in shares of common stock from 1.2 billion to 3 billion, followed by approval of a 2-for-1 stock split. All stockholders of record at the close of business on April 28 will receive one additional share of stock for each share held. As of March 31, Genentech had about 531 million shares outstanding.

• Gilead Sciences Inc., Foster City, Calif., and Southern Research Institute in Birmingham, Ala., entered a partnership in which Gilead has outsourced both early chemistry and screening work to the institute in an attempt to discover drug targets. The institute's medicinal chemists have discovered or synthesized five of the FDA-approved cancer drugs on the market, and three new cancer drugs discovered at Southern Research are in clinical trials. One of those drugs, clofarabine, recently received fast-track status from the FDA. Gilead focuses its research and clinical programs on anti-infectives.

• Hemispherx Biopharma Inc., of Philadelphia, said the results of an independent study conducted by the Genome Institute of Singapore have been publicized in Emerging Infectious Diseases. The study suggested that Hemispherx's lead drug, Alferon N Injection, tested among 19 clinically approved compounds from several antiviral pharmacologic classes, exhibits antiviral activity in an in vitro model of severe acute respiratory syndrome. The aim of the study was to investigate whether a panel of available antiviral agents would exhibit in vitro anti-SARS-coronavirus activity.

• ImClone Systems Inc., of New York, said the FDA accepted for filing and review the company's chemistry, manufacturing and controls supplemental biologics license application for licensure of its BB36 manufacturing facility. The action date is set for June 18. If the company's facility receives a license, ImClone and New York-based Bristol-Myers Squibb Co. believe they can meet full commercial demand for Erbitux (cetuximab) on an ongoing basis. The FDA approved Erbitux in February for use in combination with irinotecan to treat patients with epidermal growth factor receptor-expressing, metastatic colorectal cancer who are refractory to irinotecan-based chemotherapy and for use as a single agent in those patients who are intolerant to the chemotherapy. (See BioWorld Today, Feb. 13, 2004.)

• InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., completed a Phase IV study of Visicol tablets in patients with functional constipation or constipation-predominant irritable bowel syndrome. The 40 evaluable-patient study showed Visicol was almost 100 percent effective in increasing the number of bowel movements per week, while reducing the associated symptoms of constipation. The FDA first approved the product in 2000 as a drug to clean the bowel in preparation for colonoscopy. (See BioWorld Today, Sept. 22, 2000.)

• Lilly ICOS LLC, a joint venture of ICOS Corp., of Bothell, Wash., and Eli Lilly and Co., of Indianapolis, recorded $108.3 million in worldwide sales of Cialis (tadalafil) in the quarter ended March 31. That figure is about five times the $21.5 million posted in last year's corresponding three-month period. As of March 31, the company said nearly 2 million men have been treated with the erectile dysfunction drug.

• Lipid Sciences Inc., of Pleasanton, Calif., said preclinical data for its viral immunotherapy platform showed that simian immunodeficiency virus delipidated by Lipid's process resulted in a humoral and cell-mediated immune response at a low-antigen dose. The data support the premise that delipidating HIV has the potential to be used in a treatment for HIV-infected patients. The delipidated retrovirus, SIVmac251, elicited cellular and antibody response to an array of SIV antigens with low boost concentrations of delipidated virus without the aid of an adjuvant, it said.

• Maxim Pharmaceuticals Inc., of San Diego, said preclinical results indicate that histamine might prevent lipopolysaccharide (LPS)-induced liver injury. In the study, LPS was used to increase the severity of alcohol-induced damage. The results show the ability of histamine to prevent liver injury in a rodent model when it is delivered in a manner mimicking oral administration. Histamine is known to inhibit reactive oxygen species and LPS-induced pro-inflammatory cytokines like TNF-(alpha) in circulating inflammatory cell types in blood. The company's histamine program has moved into Phase I studies.

• MDL Information Systems Inc., of San Leandro, Calif., released its xPharm database, which offers pharmacological information on targets, disorders, agents and principles. The company said the product allows researchers to apply an understanding of interactions and relationships between compounds and biological systems early in the discovery process.

• Nabi Biopharmaceuticals Inc., of Boca Raton, Fla., reported publication of the full results of the Calcium Acetate Renagel Evaluation (CARE) study in the May 2004 issue of Kidney International. The company said the CARE study is the first randomized, double-blind, controlled, head-to-head comparison between PhosLo and Renagel (Genzyme Corp.). The studies include previously reported data presented at the November 2003 American Society of Nephrology meeting, as well as new data supporting PhosLo as first-line treatment for hemodialysis patients. The data support PhosLo's use as a first-line therapy for control of blood phosphorus levels in patients with kidney failure on maintenance dialysis, Nabi said.

• Nuevolution A/S, of Copenhagen, Denmark, said it generated what it believes to be the world's largest drug-like library comprising 100 million diverse compounds synthesized in a single test tube. The company also identified drug lead candidates that inhibit the cancer target, integrin avb3 directly from the library. Both library generation and lead candidate identification were performed using Nuevolution's Chemetics drug discovery technology.

• Oxigene Inc., of Waltham, Mass., said the European Agency for the Evaluation of Medicinal Products awarded the company orphan medicinal product designation for its lead vascular targeting agent, Combretastatin A4 Prodrug, as a treatment for anaplastic thyroid cancer (ATC). The product received the FDA's orphan drug and fast-track status designations last year. CA4P is in a Phase II trial in patients with advanced ATC and a Phase Ib/II trial in combination with chemotherapy and radiation in patients with newly diagnosed ATC.

• The Palo Alto Research Center, of Palo Alto, Calif., and The Scripps Research Institute in of La Jolla, Calif., are forming the Scripps-PARC Institute for Advanced Biomedical Studies with the intent of accelerating discovery processes in the life sciences. The two centers are collaborating to create technologies in biomedical science that will have scientific and commercial impact. The announcement coincided with a paper presented to unveil the Scripps-PARC Institute's first achievement, which is a system of detecting and monitoring cancer through blood testing at unprecedented speeds, enabling early diagnosis of cancer and other conditions.

• Provalis plc, of Flintshire, UK, said its pharmaceuticals business entered an agreement with Edmond Pharma SpA, of Milan, Italy, under which Provalis will distribute Erdotin in the UK and Republic of Ireland. The agreement is for a minimum of 10 years, with Provalis being the exclusive distributor for the first five years. It also includes an option for Provalis to purchase the product, under agreed terms, after the end of the third year. Provalis is to pay €200,000 to Edmond Pharma as a contribution toward development and regulatory costs. Erdotin (erdosteine) is one of the latest generation of mucolytic agents.

• Signet Laboratories Inc., of Dedham, Mass., made available two high-affinity purified polyclonal antibodies used for the identification and measurement of the 40- and 42-amino-acid isoforms of the protein beta amyloid. Its 40 and 42 specific antibodies represent a way to determine levels of beta amyloid 1-40 and 1-42 protein isoforms in cerebrospinal fluid, plasma and brain tissue.

• Valeant Pharmaceuticals Inc., of Costa Mesa, Calif., presented 24-week Phase II data of Viramidine demonstrating antiviral activity comparable to that of ribavirin, but with a lower incidence of anemia. Viramidine was used in combination with peginterferon alfa-2a in treatment-na ve patients with chronic hepatitis C virus. The open-label, randomized study enrolled about 180 patients. Data showed a sustained reduction in HCV RNA of about two and one-half log for all three doses of Viramidine. There were also fewer patients in the Viramidine groups with anemia.

• Xechem International Inc., of New Brunswick, N.J., executed a definitive closing agreement for its alliance with Baroda, India-based Alembic Ltd. Xechem believes the alliance will help it bring Nicosan/Hemoxin to market in Nigeria within the next 12 months. The drug has shown efficacy in clinical studies in Nigeria in treating sickle cell disease. The definitive agreement calls for the funding of up to $3 million in four-year loans from Alembic, in addition to its $640,000 equity investment in Xechem. The FDA granted orphan drug status to Nicosan/Hemoxin.