• Acuity Pharmaceuticals Inc., of Philadelphia, reported that the interim top-line safety data from the Phase I study of its lead candidate for macular degeneration, Cand5, continue to be positive, with no drug-related adverse events. The company expects full study data to be available later this year and is preparing for Phase II trials. Cand5 is an RNA-interference-based therapeutic.

• American Pharmaceutical Partners Inc., of Schaumburg, Ill., and American BioScience Inc., of Santa Monica, Calif., said patient accrual has been completed in an initial Phase II study of dose dense Abraxane administered as adjuvant therapy following Adriamycin plus Cytoxan in early stage breast cancer. The study's primary goal is to evaluate the safety of Adriamycin plus Cytoxan given every two weeks for four cycles, followed by 260 mg/m2 of Abraxane administered in a dose dense regimen, every two weeks for four cycles. Abraxane received FDA approval in January for breast cancer. American Pharmaceutical is a majority-owned subsidiary of American BioScience.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, said its partner, Cook Inc., of Bloomington, Ind., will expand its efforts to bring a paclitaxel-eluting stent for peripheral artery disease to market by launching an international trial of Cook's Zilver PTX drug-eluting stent, which will enroll 760 patients at up to 50 sites across Europe, Asia, Australia and Canada. A pilot trial is ongoing in the U.S. Cook holds a coexclusive license from Angiotech for the use of paclitaxel in the peripheral vascular and gastrointestinal fields of use.

• Ariad Pharmaceuticals Inc., of Cambridge, Mass., initiated enrollment of 35 patients with prostate cancer who have become refractory to standard hormone therapy in a multicenter Phase II trial of AP23573. In the non-randomized study, AP23573 will be administered intravenously using a weekly dosing regimen. Patients will be followed for at least nine months after enrollment but can continue on the drug until disease progression occurs.

• ArQule Inc., of Woburn, Mass., sold its headquarters building in Woburn to an affiliate of Alexandria Real Estate Equities Inc. for $40.1 million, and then entered a 10-year lease, with two five-year options to renew, for the building and one of two parcels of land it sold. ArQule said the move provides the company with additional funding for its oncology research and development efforts, and meets the goal of ending the year with sufficient resources to fund programs through 2008.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., formed a new manufacturing agreement with a U.S.-based cGMP manufacturer for large-scale quantities of its calcium phosphate-based nanotechnology (CAP). CAP will be used to expand testing by a global pharmaceutical company in the development of an oral formulation of a currently marketed injectable protein product.

• BioVision AG, of Hanover, Germany, sold its spin-off ImVision GmbH to Zurich, Switzerland-based Nextech Venture LP for an undisclosed amount. ImVision focuses on immunotherapeutics based on its Modular Antigen Transport technology to treat allergic diseases, infectious diseases and, possibly, cancer. The lead product, IVN201, for cat dander allergy, is undergoing late preclinical development and should enter the clinic in early 2006.

• Chiron Corp., of Emeryville, Calif., said The Chiron Foundation awarded a total of $90,000 to four organizations that are accelerating the discovery of novel therapies and furthering the use of science and technology in health care. The recipients are the American Society of Transplantation, the Alliance for the Prudent Use of Antibiotics, the Myelin Repair Foundation and the National Academy of Sciences. The grants will support research in the areas of organ transplants, global drug-resistance threats, myelin-repair treatments, and efforts in intellectual property policy concerning patenting and licensing genomic and protein research.

• Copernicus Therapeutics Inc., of Cleveland, said the FDA granted orphan drug designation for its DNA drug intended to treat cystic fibrosis. The company's non-viral DNA drug is designed to deliver a normal copy of the CF gene to the affected airway cells of CF patients, and could eventually provide long-term treatment for the lung manifestations of the disease.

• Cyntellect Inc., of San Diego, entered an agreement granting St. Louis-based Sigma-Aldrich Corp. an exclusive, worldwide license to commercialize Cyntellect's Cell Xpress service. Sigma-Aldrich has made a multi-million equity investment in Cyntellect, and will pay Cyntellect royalties and certain payments to access LEAP (Laser Enabled Analysis and Processing) technology. Cell Xpress is based on the LEAP platform, which is designed to enable high-throughput processes for in situ measurement of protein secretion on an individual cell basis, coupled with laser-based elimination of undesired cells.

• eXegenics Inc., of Pittsford, N.Y., said the Delaware Court of Chancery has dismissed a lawsuit filed in 2003 by the M&B Weiss Family Ltd. Partnership of 1996, alleging that the company's former directors had made unwarranted and wasteful loans, disseminated a false proxy statement to shareholders and breached their fiduciary duties to act in the best interest of the company and stockholders. The company, which discontinued its drug discovery operations in 2002 and called off a proposed merger, said it is focusing on identifying new business opportunities.

• Eyetech Pharmaceuticals Inc., of New York, said no new safety concerns were identified in year two of Macugen (pegaptanib sodium injection) use in patients, and a pharmacokinetics study also showed that the drug was well tolerated, with no evidence of systemic vascular endothelial growth factor inhibition or clinically significant ocular inflammation. Macugen is approved for neovascular (wet) age-related macular degeneration. Those data were presented at the 2005 Association for Research in Vision and Ophthalmology annual meeting in Fort Lauderdale, Fla. Also during the meeting, Eyetech presented research in vascular endothelial growth factor (VEGF) that suggests that specific isoforms might play important roles in neovascular disease in the human eye. Although results from a study in mice provided evidence that the presence of the isoform called VEGF164 is not required to drive normal vascular development in the retina, data indicated that, by specifically targeting the isoform, there was a reduction in abnormal blood vessel growth that results in diseases of the retina.

• Genaera Corp., of Plymouth Meeting, Pa., announced positive interim trial results, including safety data and visual acuity outcomes, from a Phase II trial of Evizon (squalamine lactate) in choroidal neovascularization associated with age-related macular degeneration. Data were presented at the Association for Research in Vision and Ophthalmology annual meeting. Indicating that Evizon, administered with concomitant photodynamic therapy with verteporfin (Visudyne, QLT Inc., of, Vancouver, British Columbia) was well tolerated in all subjects. ImmunoGen Inc., of Cambridge, Mass., said that South San Francisco-based Genentech Inc. renewed the agreement for certain rights to test and use ImmunoGen's Tumor-Activated Prodrug technology with Genentech's therapeutic antibodies. The original May 2000 agreement included a provision that allows Genentech to renew the agreement for one additional three-year term by paying a $2 million technology access fee. Shares of ImmunoGen (NASDAQ:IMGN) gained 51 cents Tuesday, or 9.9 percent, to close at $5.67.

• Generex Biotechnology Corp., of Toronto, said that Oral-lyn, its oral insulin spray formulation, was approved for commercial marketing and sale by the Ecuadorian Ministry of Public Health for the treatment of both Type I and Type II diabetes. The company said it expects to begin Phase III trials of Oral-lyn in Europe and Canada later this year.

• InterMune Inc., of Brisbane, Calif., said the American Journal of Respiratory and Critical Care Medicine published results from a double-blind, randomized, placebo-controlled Phase II trial evaluating pirfenidone for idiopathic pulmonary fibrosis. The 107-patient study was conducted in Japan and demonstrated that in the nine months of treatment, acute exacerbations occurred in 14 percent and 0 percent of placebo and pirfenidone patients, respectively (p=0.0031). The analysis of the primary endpoint, change from baseline in the lowest oxygen saturation during a six-minute exercise test, revealed a trend in the overall population (p=0.072) with a more pronounced treatment effect in a prespecified subgroup of patients with milder disease (p=0.0305).

• Isolagen Inc., of Exton, Pa., reported that Frank DeLape, chairman, will assume the position of interim CEO. Since 2001, DeLape has led the board and the company through its capital expansion, raising $187 million. Isolagen specializes in the development and commercialization of autologous cellular therapies for soft- and hard-tissue regeneration.

• Medivir AB, of Huddinge, Sweden, reported that an orally active, small-molecule inhibitor of Cathepsin K was selected as a candidate drug. Cathepsin K is a key protease with activity that regulates skeletal breakdown. The project's goal is to develop a drug that reduces excessive bone degradation.

• Memory Pharmaceuticals Corp., of Montvale, N.J., received a $2 million milestone payment from F. Hoffmann-La Roche Ltd., of Basel, Switzerland, related to a 2003 alliance focused on the development of nicotinic alpha-7 receptor agonists to treat neurological and psychiatric disorders. Roche made the milestone payment to maintain its option to obtain an exclusive license for MEM 3454, Memory's lead candidate in the program. The payment was triggered with the initiation of a Phase I trial for MEM 3454.

• Merrimack Pharmaceuticals Inc., of Cambridge, Mass., elected Gary Crocker chairman. Crocker initially was elected to the board in 2004, when he participated in the company's $28 million Series C funding round. Crocker currently serves as CEO and chairman of AnzenBio. Merrimack is focused on the discovery and development of treatments for autoimmune disease and cancers.

• Miikana Therapeutics Inc., of Fremont, Calif., attained an exclusive worldwide license to Basel, Switzerland-based F. Hoffmann-La Roche Ltd.'s compound, MKC-1. The cancer product has demonstrated activity against breast cancer and non-small-cell lung cancer in Phase II trials. Miikana receives rights to develop, manufacture and commercialize MKC-1, while Roche gains an equity stake in Miikana, as well as undisclosed up-front money, and potential milestone and royalty payments.

• Par Pharmaceutical Companies Inc., of Spring Valley, N.Y., entered a purchase agreement to acquire a 16 percent partnership interest in San Diego-based Optimer Pharmaceuticals Inc. The companies also have entered a joint development and collaboration agreement for a compound, known as PAR-101, a narrow-spectrum antibiotic to treat Clostridium difficile-associated diarrhea that has been granted fast-track status and is in Phase IIa studies. Under the agreement terms, Optimer will fund all expenses associated with the trials of PAR-101, while Par will be responsible for clinical development, and the submission of a new drug application. If the product receives marketing approval, Par will manufacture and market PAR-101 and retains exclusive distribution rights in the U.S. and Canada. Par also has the option to extend the collaboration agreement to include up to three additional drug candidates from Optimer's pipeline.

• PharmaFrontiers Corp., of The Woodlands, Texas, and INC Research Inc., of Raleigh, N.C., formed a strategic relationship to develop multiple sclerosis therapies. PharmaFrontiers is moving into Phase II trials with Tovaxin, a treatment based on its T-cell therapy technologies. The company chose INC based on the contract research organization's history developing CNS therapies.

• Pharmos Corp., of Iselin, N.J., received a $1.3 million grant from the Office of the Chief Scientist of Israel's Ministry of Industry and Trade. The funds will support development of drug candidates from the company's CB2-selective platform of synthetic cannabinoids. A portion of the grant will be applied to late-stage preclinical and clinical costs for developing cannabinor, the company's lead CB2-selective drug candidate, to treat pain indications.

• Predix Pharmaceuticals Inc., of Woburn, Mass., initiated Phase I trials with PRX-08066, a 5-HT2B receptor antagonist, to treat pulmonary hypertension and hypoxia-induced PH syndromes caused by chronic obstructive pulmonary disease and mountain sickness. The compound has the potential to act both as a vasodilator of pulmonary but not systemic blood vessels, and as a disease-modifying agent to slow the progression of the disease.

• Proteologics Ltd., of Rehovot, Israel, signed a feasibility study agreement with Teva Pharmaceutical Industries Ltd., of Jerusalem, involving drugs targeting ubiquitin ligases for cancer therapy. Proteologics will carry out a feasibility study involving target discovery and early drug development in return for certain payments. Teva has an option to continue drug development through commercialization by signing a definitive license and collaboration agreement with Proteologics, under which Proteologics will be entitled to milestone payments and royalties. Teva also made an equity investment in Proteologics as part of the agreement.

• Qiagen NV, of Venlo, the Netherlands, acquired the worldwide, exclusive rights and licenses to manufacture and market the complete portfolio of RNAture Inc.'s nucleic acid-isolation products from Hitachi Chemical Research Center. RNAture is a wholly owned subsidiary of Hitachi Chemical Research Center Inc., part of Hitachi Ltd., of Japan. Hitachi Chemical Research will transfer all commercial operations to Qiagen.

• Sanaria Inc., of Rockville, Md., received a $4.1 million research and development award from the U.S. Army Medical Research Acquisition Activity Group in Fort Detrick, Md. Sanaria was founded in 2003 to focus on an attenuated malaria sporozoite vaccine against Plasmodium falciparum.

• Stressgen Biotechnologies Corp., of Victoria, British Columbia, completed the $8 million sale of its bioreagent business to Stressgen Bioreagents Corp., a new company funded by Ampersand Ventures. Stressgen transferred 26 employees to the new company and will provide transitional administrative services. Proceeds from the sale will be used to advance the development of HspE7, Stressgen's lead candidate for human papillomavirus-related diseases. The company announced last week that it would cut its work force in half to focus on HspE7. (See BioWorld Today, April 15, 2005, and April 29, 2005.)

• Synta Pharmaceuticals Corp., of Lexington, Mass., is postponing its initial public offering. Its registration statement, filed in January, will remain on file with the SEC. The company did not provide any reasons for the delay. Synta set the price range last month between $14 and $16 per share for 6 million shares, with proceeds totaling from $84 million to $96 million. Funds were going to be used to advance its product pipeline, including two products that are in Phase II trials for inflammatory disease and cancer, as well as other clinical and preclinical work, corporate expenses and potential acquisitions or investments. (See BioWorld Today, Jan. 20, 2005.)

• VaxGen Inc., of Brisbane, Calif., said the U.S. District Court for the Northern District of California dismissed with prejudice a class-action lawsuit filed against the company in March 2003. The court dismissed the case in April but provided the plaintiffs an opportunity to amend their complaint, which they did not do. The lawsuit followed news that VaxGen's AidsVax product reduced HIV infection by 3.8 percent, missing its primary endpoint. (See BioWorld Today, Feb. 25, 2003.)

• YM BioSciences Inc., of Mississauga, Ontario, completed the purchase of Delex Therapeutics Inc., also of Mississauga, a private company developing inhalation-delivered fentanyl products to treat cancer pain. Delex's lead product, AeroLEF, for acute and breakthrough pain, has completed preliminary efficacy trials and will undergo further Phase II trials this year. YM issued 1.6 million common shares to Delex shareholders and may issue up to 1.8 million shares in escrow to be released in tranches on specific dates, as well as up to 2.8 million shares for achieved milestones. If AeroLEF is approved in the U.S., YM will pay Delex shareholders $4.75 million in cash or common shares.