The Aaron Diamond AIDS Research Center, an affiliate of the Rockefeller University in New York, and the International AIDS Vaccine Initiative, reported they began a clinical trial of a new investigational vaccine to prevent HIV/AIDS. The trial is designed to evaluate the safety of a new DNA vaccine called Advax. The vaccine is designed to stimulate immune responses to prevent people who are uninfected with HIV/AIDS from contracting the disease, and the trial will gather preliminary data on whether Advax stimulates those immune responses.

• Advanced Viral Research Corp., of Yonkers, N.Y., said administration of AVR118, its immunomodulator formerly known as Product R, in animals with induced experimental allergic encephalomyelitis suppressed progression of the demyelinating neurological disease. The company added that the animal model, developed by the Weizmann Institute of Science in Rehovot, Israel, serves as a potential model for the use of AVR118 in treating multiple sclerosis.

• Affymetrix Inc., of Santa Clara, Calif., reported its intention to begin an offering of $100 million principal amount of senior convertible notes due 2033 to qualified institutional buyers. The notes will be convertible into Affymetrix stock at a price to be determined. The notes will be redeemable at the company's option beginning Monday at a redemption price of 100 percent of their principal amount. Holders of the notes will have the right to require the company to repurchase some or all of their notes on Dec. 15, 2008; Dec. 15, 2013; Dec. 15, 2018; and Dec. 15, 2023; and Dec. 15, 2028.

• Allergan Inc., of Irvine, Calif., and Inspire Pharmaceuticals Inc., of Durham, N.C., entered a co-promotion agreement in the U.S. for Elestat (epinastine HCL ophthalmic solution 0.05 percent) within the ophthalmic specialty area. Elestat was approved by the FDA in October 2003 for the prevention of itching associated with allergic conjunctivitis. Inspire will provide Allergan with an up-front payment, and Allergan will pay a royalty to Inspire on Elestat net sales. In addition, the agreement calls for Allergan to significantly reduce its existing royalty payment to Inspire for Restasis that is covered by a previous agreement between Allergan and Inspire. Inspire will have the primary responsibility for selling, promotional and marketing activities and will incur associated costs. The companies will work collaboratively on overall product strategy and management.

• AmpliMed Corp., of Tucson, Ariz., said its compound Amplimexon was granted orphan drug designation for the treatment of pancreatic cancer by the FDA. Amplimexon already was granted orphan drug designation for the treatment of metastatic malignant melanoma and multiple myeloma. The drug is undergoing a Phase I dose-escalation study to establish safety and tolerability, and it is anticipated that Phase II trials will begin in 2004 in at least two cancer indications.

• Angiogenix Inc., of Burlingame, Calif., said it will employ a clinical research organization called Novotech Pty. Ltd., of Sydney, Australia, to conduct Australia- and New Zealand-based trials of Angiogenix's Acclaim (organic nitrate combined with L-arginine) for chronic angina. Novotech's role is part of an international team that also includes research organizations in North America and Europe.

• Antares Pharma Inc., of Exton, Pa., received a milestone payment from Eli Lilly and Co., of Indianapolis, the licensee of Antares' needle-free injection technology in the fields of diabetes and obesity. The milestone payment followed the successful outcome of a meeting held with representatives of the FDA on Nov. 6, at which the companies were able to clarify the regulatory expectations for the ongoing development program.

• Barrier Therapeutics Inc., of Princeton, N.J., established agreements with Alliance Pharmaceuticals Ltd., of Johannesburg, South Africa, and Neopharm Ltd., of Petach-Tikva, Israel, for the marketing, sales and distribution of Zimycan, its lead topical ointment for Candida-associated diaper dermatitis. Alliance will be responsible for marketing, sales and product distribution in the UK and Scandinavia, while Neopharm will embark on the same initiatives in Israel and Turkey. Financial terms were not disclosed.

• Bioject Medical Technologies Inc., of Bedminster, N.J., reported that the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases in Bethesda, Md., recently began its first clinical trial of a vaccine to prevent Ebola infection using the Biojector 2000. The B-2000 is a needle-free injection system powered by a compressed gas system and is the only device being used in the study.

• Biotica Technology Ltd., of Cambridge, UK, moved all its research and support facilities to Chesterford Research Park. The company is focused on discovering pharmaceuticals through a targeted alteration of biosynthetic pathways, producing natural products.

• Boston Life Sciences Inc., of Boston, raised $8 million following a private placement of convertible preferred stock and warrants with a small group of institutional and private investors. The preferred stock is convertible into common stock at an initial price of $1.25, and the warrants are for an additional 3.5 million common shares exercisable through December 2007 at prices between $1.49 and $1.55 apiece. The company expects to use the funds to support its second Phase III trial of Altropane as a diagnostic for Parkinsonian syndromes, and to eventually file a new drug application for the product. Burnham Hill Partners acted as the transaction's exclusive placement agent.

• Cel-Sci Corp., of Vienna, Va., said data reported by Naval Medical Research Center collaborators at the American Society of Tropical Medicine and Hygiene meeting in Philadelphia showed that its CEL-1000 peptide was able to reduce a challenge dose of 50,000 malaria-causing sporozoites in animals by a factor of 400 (from 100 percent down to 0.25 percent), as measured by the level of parasite mRNA detected in the liver 42 hours after challenge. The challenge amount used in these sets of experiments is 500 times higher than that used in the protection studies in which CEL-1000 was shown to protect 100 percent of the animals against malaria infection, Cel-Sci added.

• Celsion Corp., of Columbia, Md., said results were presented of preclinical studies by the FDA and the National Institutes of Health in Bethesda, Md., on the feasibility of using Celsion's drug compound, ThermoDox, in combination with radiofrequency ablation (RFA) in the treatment of liver cancer. The studies corroborated the premise that the combination of RFA with ThermaDox might reduce high local recurrence rates of liver tumors currently treated with RFA alone. ThermoDox is Celsion's temperature-sensitive liposomal formulation, which encapsulates doxorubicin. Results were presented at the 89th annual Radiological Society of North America meeting last week in Chicago.

• Cerus Corp., of Concord, Calif., is the subject of a class action filed by Milberg Weiss in the U.S. District Court for the Northern District of California on behalf of purchasers of Cerus stock during the period between Oct. 25, 2000, and Sept. 3, 2003. The complaint charges Cerus and certain of its officers and directors with violations of the Securities Exchange Act of 1934. The complaint alleges, among other things, that the defendants artificially inflated the price of Cerus stock by issuing a series of materially false and misleading statements about the company's development program for the Intercept Blood System for Red Blood Cells, a system that applies Helinx technology for the treatment of red blood cell concentrates. On Sept. 5, the company said it was stopping a Phase III trial of the system. (See BioWorld Today, Sept. 5, 2003.)

• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., appointed Colin Stewart president and CEO. Stewart also will be a member of the board. Most recently, he was president and CEO of Muro Pharmaceutical Inc., a subsidiary of Viatris GmbH. CollaGenex is a specialty pharmaceutical company focused on providing therapies to the dental and dermatology markets.

• GeneCopoeia Inc., of Frederick, Md., released two new sets of more than 15,000 OmicsLink human open reading frame (ORF) clones in vectors containing T7 and CMV promoters, respectively. The clone sets contain full-length ORFs of human genes from start-to-stop codons, and are constructed from a collection of verified human full-length cDNAs.

• Genta Inc., of Berkeley Heights, N.J., reported that the company completed the submission of its new drug application for Genasense (oblimersen sodium) used in combination with dacarbazine for the treatment of advanced malignant melanoma on Monday. The application process, which began in the third quarter, was submitted under the FDA's fast-track program. Genta, along with Aventis SA, of Strasbourg, France, initiated the rolling NDA in September. The company requested priority review for Genasense. Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced cell death. (See BioWorld Today, Sept. 11, 2003.)

• GenVec Inc., of Gaithersburg, Md., said the National Eye Institute in Bethesda, Md., awarded two independent Small Business Innovation Research grants totaling $200,000 to enhance research efforts using PEDF (Pigment Epithelium-Derived Factor) for the treatment of eye diseases, such as wet age-related macular degeneration. PEDF is a natural inhibitor of angiogenesis in the eye and is being used in GenVec's ophthalmology product candidate, AdPEDF, in Phase I trials for the treatment of wet age-related macular degeneration. The most recent grant, awarded in October, will focus on the production and testing of a high-capacity adenovector, which might produce PEDF protein in the eye for longer periods of time.

• Genzyme Corp., of Cambridge, Mass., closed its previously announced sale of 1.25 percent convertible senior notes. The purchases exercised their option to purchase an additional $90 million in notes, raising gross proceeds to $690 million. The notes are convertible into Genzyme common stock at a price of $71.24 per share. Genzyme used $300 million of the proceeds to pay off amounts outstanding under its credit facility. It expects to use the remainder to redeem outstanding 3 percent debentures and for general corporate purposes.

• Innate Pharma SAS, of Marseille, France, granted exclusive rights to a family of receptor targets expressed by natural killer cells to Novo Nordisk A/S, of Bagsvaerd, Denmark. They will collaborate with Italian, French and Swedish academic institutions to further research the products for cancer treatment. Novo Nordisk received full development and commercialization rights, though Innate retained some rights to later develop the product in some undisclosed orphan indications, and also is eligible for license fees, milestone payments and royalties. More specific financial terms were not disclosed.

• InNexus Biotechnology Inc., of Vancouver, British Columbia, said findings published at www.kluweronline.com pointed to a monoclonal antibody-based delivery system for intracellular targets using its SuperAntibody technology (SAT). Researchers at Immpheron Inc., of Lexington, Ky., used an SAT-modified monoclonal antibody to caspase 3, an enzyme involved in the apoptotic cascade, which imparted the ability to penetrate into cells without incurring toxicity. The modified antibody rapidly entered cells, bound to its target, and inhibited its activity. The SuperAntibody compared to a small molecule peptide inhibitor produced comparable inhibition.

• Janssen Pharmaceutica Products LP, a unit of Johnson & Johnson, of New Brunswick, N.J., said Swedish schizophrenia patients treated with Risperdal Consta ([risperidone] long-acting injection) for more than two years to almost five years were significantly less likely to be hospitalized due to symptom relapse than before they were treated with the therapeutic option. Also, patients in the retrospective analysis study who were hospitalized after treatment with Risperdal Consta had significantly shorter hospital stays, on average, than before initiation of new therapy. The product was developed in collaboration with Alkermes Inc., of Cambridge, Mass.

• Kemin Pharma, of Herentals, Belgium, entered a collaborative molecule-screening program with the U.S. Army Medical Research Institute for Infectious Diseases in Fort Detrick, Md., which will screen Kemin's library of carbohydrate-based small molecules for effectiveness against severe acute respiratory syndrome and smallpox. Kemin said its internal screenings have identified several active and selective lead molecules effective against cytomegalorvirus, hepatitis C virus and herpes simplex virus.

• Maxim Pharmaceuticals Inc., of San Diego, reported that the U.S. District Court for the Southern District of California dismissed, with prejudice, the federal class-action securities complaint filed by Blake Martin, on behalf of himself and purportedly on behalf of a class of others similarly situated. On Dec. 14, 2000, Martin filed a complaint in the same court against Maxim alleging that the defendants violated the federal securities laws by purportedly issuing false and misleading statements to the securities markets. In December 2000, an FDA panel voted 14-0 against Maxim's Maxamine, a product developed for advanced metastatic melanoma. (See BioWorld Today, Dec. 14, 2000.)

• MGI Pharma Inc., of Minneapolis, said it presented two posters and had an abstract published regarding Aloxi (palonosetron hydrochloride) injection data that were presented at the 26th annual San Antonio Breast Cancer Symposium, the 38th American Society of Health System Pharmacists mid-year clinical meeting, and the American Society of Hematology 45th annual meeting. Aloxi was approved by the FDA on July 25 for acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy and for delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

• Micrologix Biotech Inc., of Vancouver, British Columbia, out-licensed exclusive worldwide rights to MBI-1313 to Spring Bank Technologies Inc., of Milford, Mass. Micrologix will receive up to $3.5 million in milestone payments during development of the compound, which is a nucleotide analogue under development for hepatitis B virus; collect royalties upon commercialization; and obtain an equity position in Spring Bank, which received a $2.6 million grant from the National Institutes of Health in Bethesda, Md., to advance the compound's development.

• Neurochem Inc., of Montreal, said that at its annual general and special meeting of shareholders, it reported additional positive interim results on cognitive function as measured by the ADAS-cog test in mild to moderate Alzheimer's disease patients participating in its ongoing open-label Phase II extension study. The patients reported on have completed nine and 12 months of treatment on the highest dose (300 mg daily) of Alzhemed. Data include the most recent results in 23 mild to moderate patients using the ADAS-cog test showing that patients treated with Alzhemed have shown an average score of +2 points after nine months, as opposed to +5 points on average in comparable historical controls in a longitudinal study with AD patients. Of that group, 14 mild AD patients showed a score after nine months of treatment of -0.8 points on average as opposed to + 4.3 points on average in comparable historical controls.

• Neurogen Corp., of Branford, Conn., corrected a media report concerning its exclusive worldwide alliance with Merck & Co. Inc., of Whitehouse Station, N.J., to develop next-generation drugs for pain and other disorders, originally reported on Dec. 1. A media report incorrectly stated that Neurogen was not eligible to receive milestone payments and royalties on one compound that originated with Merck's research. In fact, Neurogen said, the companies are pooling all VR1 drug candidates previously discovered by each company, and Neurogen is eligible to receive identical milestone payments and royalties on all VR1 drug candidates discovered by either party prior to or during the exclusive collaboration with the exception of a single early milestone payment. The agreement assured Neurogen of at least $42 million. (See BioWorld Today, Dec.2, 2003.)

• Panacea Pharmaceuticals Inc., of Gaithersburg, Md., entered an agreement with JSR Corp., of Tokyo, to develop and improve various assays within Panacea's HAAH oncology program. JSR will provide its expertise and capabilities in magnetic particle fabrication and surface chemistries toward the development of specialized particles designed for maximum performance in various assays that measure HAAH. The assays represent potential tools for cancer detection, diagnosis, prognosis, treatment selection and follow-up. Financial terms were not disclosed.

• Protein Mechanics Inc., of Mountain View, Calif., said the first paper on its Imagiro drug discovery platform was published in the Nov. 26, 2003, issue of the Journal of the American Chemical Society. In a demonstration, Protein Mechanics scientists simulated an accurate ab initio folding of a well-studied small protein in two orders of magnitude less CPU time than the previous record, which was published one year earlier in the same journal.

• Schering AG, of Berlin, said the first multiple sclerosis patient entered the second phase of the Beyond trial, a Phase III trial aiming to enroll more than 2,100 patients. That trial will compare the efficacy of a new, higher-dose Betaferon (500 mcg) with Betaferon 250 mcg and glatiramer acetate in patients with relapsing-remitting MS. Recently, the company reported positive safety and tolerability data from the first phase of the study program examining Betaferon 250 mcg and Betaferon 500 mcg. Also, one of the treatment arms in Beyond will compare Betaferon with glatiramer acetate.

• Sepracor Inc., of Marlborough, Mass., said it priced a new issue of $600 million of convertible senior subordinated notes, which are being issued in a private placement. The sale of the notes is expected to close Friday, subject to customary closing conditions. Sepracor intends to use a portion of the net proceeds from the offering to redeem all of its outstanding 5.75 percent convertible subordinated notes due 2006, representing about $435 million in aggregate principal amount plus accrued but unpaid interest. In connection with the call spread transaction, the company purchased call options on 19.7 million shares of Sepracor stock, with a strike price of $29.84 per share.

• Shire Pharmaceuticals Group plc, of Basingstoke, UK, entered an agreement to out-license Japanese rights to Fosrenol (lanthanum carbonate) to Bayer AG, of Leverkusen, Germany. The non-aluminium, non-calcium-based phosphate binder is approved for hyperphosphataemia associated with end-stage renal disease, which afflicts about the same number of Japanese patients as in the U.S. Shire, which will receive a $12 million up-front payment and potentially more than $70 million total, called the out-licensing arrangement in line with its strategy of focusing direct operations in North America and Europe, while finding complementary partners in other worldwide territories.

• SurroMed Inc., of Mountain View, Calif., and Ingenuity Systems, of Mountain View, Calif., reported that SurroMed licensed Ingenuity Pathways Analysis, a web-delivered application designed to enable biologists to discover, visualize and explore therapeutically relevant networks significant to their experimental results. SurroMed focuses on biomarker-enabled drug discovery and development.

• Targeted Genetics Corp., of Seattle; the nonprofit International AIDS Vaccine Initiative (IAVI); and Columbus Children's Research Institute have begun testing in humans a new vaccine candidate to prevent HIV/AIDS. A clinical trial of vaccine candidate tgAAC09 has begun in Belgium. TgAAC09 uses Targeted Genetics' rAAV (recombinant adeno-associated viral vector) technology to elicit immune system responses in an effort to prevent people uninfected with HIV/AIDS from contracting the disease. TgAAC09 is designed to elicit two different types of immune responses, an antibody response and a cell-mediated response.

• Third Wave Technologies Inc., of Madison, Wis., said the Armed Forces Institute of Pathology (AFIP) selected the company's Invader analyte-specific reagents (ASRs) exclusively for its cystic fibrosis (CF) genetic screening. AFIP will use the Invader ASRs to screen select U.S. military personnel for genetic mutations associated with CF to determine whether those individuals are carriers for the disease. Financial terms were not disclosed.

• Tularik Inc., of South San Francisco, said Sankyo Co. Ltd., of Tokyo, selected a target for further development under their collaboration focused on orphan G protein-coupled receptors (GPCRs). Sankyo will fund research and preclinical development activities relating to compounds with activity against the selected target for up to four years. The parties will share equally all clinical development costs and profits in the U.S. and Europe. Tularik is entitled to milestone and royalty payments. Other financial terms were not disclosed.

The University of Sheffield in the UK said its researchers published Phase III findings in the Dec. 9, 2003, online edition of the Journal of Clinical Oncology showing that the use of low-dose interferon following surgery in patients with high-risk melanoma failed to improve survival. After five years, the 674-patient study showed that 63 percent of patients who received interferon following surgery and those who did not experienced a recurrence of disease. Also, 46 percent of patients in both groups died. Five-year overall and recurrence-free survival was the same for both groups, estimated at 44 percent and 32 percent, respectively.

• Valeant Pharmaceuticals International, of Costa Mesa, Calif., priced $300 million worth of senior notes due 2011. The notes will pay interest at a rate of 7 percent per annum. Valeant Pharmaceuticals may, at its option, redeem some or all of the notes after Dec. 15, 2007. Ribapharm Inc., a wholly owned subsidiary of Valeant Pharmaceuticals, will also be an obligor with respect to the notes, jointly and severally with Valeant Pharmaceuticals, until all of the company's outstanding 6.5 percent convertible subordinated notes due 2008 are retired. The offering is expected to close on Dec. 12.

• Xechem International Inc., of New Brunswick, N.J., entered a binding letter of intent to acquire all the outstanding shares of Ceptor Corp., a privately held drug-targeting company focused on neuromuscular diseases. Xechem will issue $6 million of convertible preferred stock to Ceptor's shareholders, and assume about $300,000 of debt. No shares will be converted until at least 12 months from the closing of the transaction, which is to occur no later than next month. Ceptor's shareholders will receive milestone payments related to the development progression of its compounds.

• Xencor Inc., of Monrovia, Calif., named Harry Stylli CEO and president. He most recently was the president and CEO of CovX Pharmaceuticals, a private company founded in 2001 to exploit antibody technology developed at the Scripps Research Institute in La Jolla, Calif. Privately held Xencor is a preclinical-stage company developing protein therapeutics using its rational protein design platform.