• Achillion Pharmaceuticals Inc., of New Haven, Conn., and the University of Maryland at Baltimore County said their discovery of a target on the HIV molecule was published in this week's Journal of Molecular Biology. Specifically, the researchers discovered a number of compounds that bound to a specific area of the capsid protein thought to play a key role in the assembly process necessary for HIV to mature to its infectious form. Privately held Achillion said preclinical findings demonstrated that the anti-HIV activity of inhibitors was due to disruption of the HIV-1 capsid protein.

• Amylin Pharmaceuticals Inc., of San Diego, responded to Swiss regulatory authorities reviewing the company's marketing application for its diabetes drug candidate Symlin (pramlintide acetate). The response includes a summary of 16-week data from a recently completed dose-titration study, and reports from four completed pharmacology studies previously requested by the FDA. The data indicate that initiation of Symlin therapy using a dose-titration protocol reduced the impact of nausea and that the drug was associated with a positive effect on post-meal glucose. The data also showed a reduction in HbA1c at 16 weeks consistent with the non-inferiority objective for the study. Amylin plans to submit an amendment to its new drug application in the second quarter, more than a year and a half after the FDA issued an approvable letter requiring additional tests. (See BioWorld Today, Oct. 15, 2001.)

• Axon Instruments Inc., of Union City, Calif., released its four-color, upgradeable GenePix Professional 4200A scanner for genomics and proteomics microarray research. The product allows a customer to choose up to four internal lasers and 16 emission filters.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., reported positive preclinical data on its calcium phosphate (CAP) delivery system for oral insulin at the Protein and Peptide Formulation Strategies meeting in Boston. The product, called CAPIC, reduced blood glucose levels in mice by 80 percent within one to two hours of treatment, a reduction that was maintained for 10 hours. In the control group, the insulin solution alone reduced blood glucose levels by 25 percent within the first half-hour to an hour after treatment, but levels returned to baseline within a few hours. CAPIC lowered blood glucose levels in rats by 80 percent six hours after administration, but there was no notable change in glucose levels following administration of insulin solution alone.

• BioTrove Inc., of Woburn, Mass., said it relocated its corporate headquarters from Cambridge, Mass., to a 20,000-square-foot facility on Gill Street in Woburn. The new location is designed to allow BioTrove to continue to expand the commercialization and development of its lead technologies, the Living Chip and Lab-on-a-Tape.

• Cell Genesys Inc., of South San Francisco, began enrollment in a multicenter Phase II trial of its GVAX lung cancer vaccine in patients with advanced-stage, non-small-cell lung cancer. Those in the 75-patient trial, the first of two GVAX Phase II trials planned for this year, will be randomized to receive GVAX with or without low-dose cyclophosphamide. The National Cancer Institute, a unit of the National Institutes of Health in Bethesda, Md., will sponsor the second trial, which will focus on bronchoalveolar carcinoma patients.

• Cellectis SA, of Paris, a spin-off from the Pasteur Institute, granted Deltagen Inc., of Redwood City, Calif., a worldwide, nonexclusive license under the patent family relating to a process for the specific replacement or insertion of a gene in the receiver genome by homologous recombination. Cellectis granted Deltagen the right to use its technologies for in vitro and in vivo modifications and manipulations of the genetic material of rodents. Financial terms and conditions of the agreement were not disclosed.

• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., received Swiss marketing approval for its lead product, Periostat (doxycycline tablets 20mg). CollaGenex has an exclusive marketing and distribution agreement with Karr Dental AG, of Zurich, which expects to introduce the product in about six months following labeling translations in German, Italian and French.

• CV Therapeutics Inc., of Palo Alto, Calif., reported at the American College of Cardiology meeting in Chicago that angina patients with diabetes who participated in its CARISA (Combination Assessment of Ranolazine in Stable Angina) trial showed a similar increase in symptom-limited exercise duration and a similar adverse event profile as angina patients without diabetes. Further subanalysis of the Phase III trial of Ranexa (ranolazine) showed that reductions in the number of weekly angina attacks and nitroglycerin consumption were similar in diabetic and nondiabetic patients. The company filed for FDA approval at the end of last year. (See BioWorld Today, Dec. 31, 2002.)

• De Novo Pharmaceuticals Ltd., of Cambridge, UK, and Peakdale Molecular Ltd., of Derbyshire, UK, entered a joint collaboration to exploit their respective skills in molecular design and chemistry synthesis. The collaboration's first objective is to make available from Peakdale a range of screening compounds suitable for use in lead discovery, initially targeted at subfamilies within the GPCR superfamily. Further objectives are based on the application of acquired knowledge to increase the selectivity of the approach in collaboration with pharmaceutical companies. Financial terms were not disclosed.

• Dendreon Corp., of Seattle, reported the filing of a registration statement with the SEC in connection with its proposed acquisition of Corvas International Inc., of San Diego, in a stock-for-stock merger. Dendreon estimated that it will issue about 12.4 million shares of its common stock to fomer Corvas stockholders in connection with the combination of the companies and is filing the registration statement in connection with those shares. Dendreon reported the merger agreement to acquire Corvas in a $72.9 stock transaction in February. The transaction would leave Dendreon with about $110 million in cash, after paying off existing Corvas convertible debt. Upon closing, expected in the second quarter, Dendreon would own about 68.6 percent of the combined company, with Corvas shareholders holding the rest. (See BioWorld Today, Feb.26, 2003.)

• EntreMed Inc., of Rockville, Md., reported that the standstill period pursuant to its Celgene Corp. agreement ended at midnight on March 31. In addition, EntreMed said it is moving toward expanding its strategic partnership with Celgene, of Warren, N.J. The partnership is being solidified to target drug discovery and validation in the areas of cancer and inflammation. Both companies may also perform research and preclinical development for each other regarding small molecules from their preclinical programs. In January, EntreMed reported that it signed a deal valued at about $27 million with Celgene for EntreMed's thalidomide analogue program. (See BioWorld Today, Jan. 3, 2003.)

• Ester Neurosciences, of Honolulu and Herzliya, Israel, reported that the results of a successful Phase Ib trial using EN101 for myasthenia gravis were presented at a special late-breaking science session of the American Academy of Neurology. The study demonstrates for the first time effective and safe use of an orally administered antisense therapy for a neurological condition, it said, as 15 of 16 patients showed a clear symptomatic improvement due without any adverse events.

• Genaissance Pharmaceuticals Inc., of New Haven, Conn., entered an agreement to acquire substantially all of the assets of DNA Sciences Inc., of Fremont, Calif., for about $1.3 million in cash and common stock. DNA Sciences also said it voluntarily filed for reorganization under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the Northern District of California. Concurrently, DNA Sciences will seek court approval for a prenegotiated asset purchase agreement by Genaissance. DNA Sciences is a privately held applied genetics company focused on developing DNA diagnostics.

• Genta Inc., of Berkeley Heights, N.J., filed its completed supplemental new drug application submission to the FDA for Ganite (gallium nitrate injection). The sNDA was submitted for the treatment of cancer-related hypercalcemia that has not responded to hydration. The company was advised that the sNDA will be reviewed as a manufacturing supplement and will be subject to a four-month review period.

• Geron Corp., of Menlo Park, Calif., reported the publication of research results that describe the production of hepatocytes from human embryonic stem cells (hESCs). The studies demonstrate that cells with multiple characteristics of hepatocytes, including drug-metabolizing enzyme activity, can be reproducibly differentiated from hESCs. The cells have potential for widespread use in drug discovery research as well as for transplantation therapy for patients with liver failure, the company said. As published in the March issue of Cell Transplantation, Geron scientists describe protocols that differentiate hESCs into human hepatocytes that express albumin, alpha-1 antitrypsin, glycogen and other proteins found in human adult liver cells. Geron's stock (NASDAQ:GERN) rose $1.46 Tuesday, or 27.6 percent, to close at $6.75.

• Ingenuity Systems Inc., of Mountain View, Calif., entered a partnership with a pair of cancer research foundations, ABC2 and CaP CURE, to test existing chemotherapeutic agents against recently discovered gene defects associated with prostate and brain cancer pathways. Researchers from Cedars-Sinai Medical Center, the University of Michigan, the University of California at San Francisco and the University of California at Los Angeles will apply Ingenuity's Pathways Knowledge Base, software that delivers biologic insights from researchers' experimental data by computationally discerning disease pathways de novo from genomic data. Financial terms were not disclosed.

• Insert Therapeutics Inc., of Pasadena, Calif., reported positive preclinical data of its Cyclosert drug delivery technology used to systemically deliver the anticancer agent, camptothecin, in a human tumor xenograft study in mice. Specifically, treatment with Cyclosert-camptothecin produced lower median tumor size (256 mg vs. 1,568 mg), greater tumor growth delay (227 percent vs. 97 percent) and reduced median tumor burden in animals whose tumors had not reached the 1.5-gram endpoint by the end of the study.

• IntraBiotics Pharmaceuticals Inc., of Mountain View, Calif., said in order to evaluate other alternatives it postponed the vote on a proposal to approve and ratify a proposed private placement regarding the sale of 350 shares of Series A stock until April 23. The stockholder meeting to vote on other proposals will be held Wednesday as planned.

• Matritech Inc., of Newton, Mass., said it closed the sale of $5 million of 7.5 percent convertible debentures and warrants to purchase 784,314 shares of common stock at an initial exercise price of $2.27, including warrants to purchase 98,039 shares of common stock issued to a placement agent. Matritech intends to use the net proceeds from the private placement for ongoing in vitro diagnostic development, marketing, clinical trials, working capital, capital expenditures and general corporate purposes.

• MediGene AG, of Martinsried, Germany, spun out its cardiological research team of about 25 employees into Larnax GmbH, jointly established with the seed capital investment company BioM AG, also of Martinsried, to develop drugs against cardiac and metabolic diseases. MediGene, which holds about a 25 percent share of Larnax, said the spin-off will save it about €6.5 million in an effort to focus on its core tumor disease therapeutic programs.

• NicOx SA, of Sophia Antipolis, France, said NCX1020, its nitric oxide-donating derivative of budesonide, started clinical development. Budesonide is a steroid used in treatment of chronic asthma by virtue of its anti-inflammatory activity. NCX1020 is the first of a new class of inhaled nitrosteroids aimed at the treatment of severe respiratory diseases such as asthma and chronic obstructive pulmonary disease. The Phase I study is designed to assess the general safety and tolerability of inhaled NCX1020 and its effect on pulmonary function at increasing doses.

• Research Corporation Technologies, of Tucson, Ariz., said preclinical studies of chimeric natriuretic peptides to rapidly treat acute congestive heart failure (CHF) showed lead candidates are nonimmunogenic and potent during repeated dosing studies in primates. The company is seeking a license to continue developing the peptides for CHF and other indications. RCT has an exclusive worldwide license to the technology developed by John Burnett and Ondrej Lisy at the Mayo Clinic in Rochester, Minn.

• SuperGen Inc., of Dublin, Calif., reported that data from a published clinical study suggest that its anticancer compound Nipent (pentostatin for injection), in combination with cyclophosphamide, is an active regimen for the treatment of previously treated patients with chronic lymphocytic leukemia. The results from a Phase II study appear in the April 1, 2003, issue of the Journal of Clinical Oncology. Of 23 patients treated, there were 17 responses (including four complete responses and 13 partial responses) for an overall response rate of 74 percent. Nipent is not approved as a combination therapy or as a treatment for chronic lymphocytic leukemia.

• Targeted Genetics Corp., of Seattle, signed a contract manufacturing agreement with GenVec Inc., of Gaithersburg, Md. Targeted Genetics will conduct initial process feasibility studies in support of the potential manufacturing of clinical-grade material to supply trials of certain GenVec products. Financial terms of the agreement, designed to leverage Targeted Genetics' manufacturing capabilities, were not disclosed.

• The Immune Response Corp., of Carlsbad, Calif., raised $2 million through the sale of a short-term convertible promissory note to Cheshire Associates LLC. The note, which bears an annual interest rate of 8 percent, is convertible into either shares of common stock at $1.23 apiece (the closing price the day before the deal closed) or an equal amount of such other securities that the company may offer in the future. The company said it would use the funding to finalize clinical plans for its lead product candidate, Remune, being developed to treat HIV.

• Tm Bioscience Corp., of Toronto, acquired a nonexclusive license from LGC Ltd., of Teddington, UK, for the use of LGC's CYP2D6 gene patents in the company's Tag-It Mutation Detection Kit for P450-2D6. The genetic test kit will be used to identify the presence or absence of mutations common in patients with atypical drug metabolism, which can lead to adverse drug responses.

• V.I. Technologies Inc., of Watertown, Mass., said the SEC declared effective its registration statement for the offering of its common stock with a maximum value of $20 million through the distribution of subscription rights to its shareholders. Shareholders of record on March 31 will receive 0.87 subscription rights for each share of stock that they own. That will entitle shareholders to purchase 19.8 million shares of Vitex stock. The exercise price would be $1.02 per share, the same price as the Pall Corp. $4 million Phase III milestone commitment. Vitex said it has received nonbinding expressions of interest from certain institutional and venture capital shareholders and affiliates. To date, the expressions of interest total between about $14 million and $19 million, Vitex said. Vitex is developing Inactine, a product designed to inactivate viruses, bacteria and parasites in blood.

• VaxGen Inc., of Brisbane, Calif., reported at the Keystone Symposia additional summaries of its Phase III HIV/AIDS vaccine trial in North America and Europe. According to the San Francisco Chronicle, the company said possible benefits found in African American and Asian study subjects might be associated with a small sample size in the trial studying AidsVax B/B. VaxGen also said there was no evidence supporting a secondary hypothesis that the viral load in vaccinated patients who contracted HIV would be less than in nonvaccinated patients. When first released, data showed that the reduction of infection among the more than 5,000 volunteers who received at least three doses was 3.8 percent (p=0.76). The news dropped the company's share value nearly in half to $6.86. VaxGen's stock (NASDAQ:VXGN) fell 70 cents Tuesday, or 23 percent, to close at $2.34. (See BioWorld Today, Feb. 25, 2003.)

• ViroLogic Inc., of South San Francisco, said results of a study published in the current issue of the Journal of Infectious Diseases support the use of its PhenoSense HIV Replication Capacity assay as an additional source of information for prognostic and therapeutic decisions in the management of HIV/AIDS patients. ViroLogic said study results showed that several factors - HIV's replication capacity, HIV co-receptor tropism, activation of immune cells and immune responses to HIV - may impact the progression of disease.

• XOMA Ltd., of Berkeley, Calif., said its board adopted a new shareholders rights plan, essentially renewing an October 1993 rights plan that expired Dec. 31. XOMA said the plan was not issued in response to any outside effort to gain control of the company.