• Aegis Therapeutics Inc., of San Diego, entered two agreements with undisclosed research partners to evaluate the application of its Intravail technology for development of formulations for the nasal delivery of compounds to treat Type II diabetes and an undisclosed metabolic disease. Depending on results from initial feasibility studies, designed to assess the relative bioavailability of nasally delivered formulations compared to injectable dosage forms, the peptide and protein drugs will be advanced into human trials by Aegis' research partners. Financial terms were not disclosed.

• Altus Pharmaceuticals Inc., of Cambridge, Mass., said it completed a Phase I study of ALTU-238, a long-acting crystalline formulation of recombinant human growth hormone, and is preparing to begin a Phase II trial to study the safety and biological activity of repeated doses of the drug in adults with growth hormone deficiency. The company said data from the Phase I trial is expected to confirm the use of Altus' crystallization technology by extending the release and improving the stability of injectable protein therapeutics.

• Amgen Inc., of Thousand Oaks, Calif., said new data from a Phase II study demonstrated that Aranesp (darbepoetin alfa) administered as a fixed dose of 500 mg once every three weeks is at least as effective as 2.25 mcg/kg of darbepoetin alfa administered once weekly, with respect to the need for red blood cell transfusions in cancer patients with chemotherapy-induced anemia. The company said Aranesp also appears effective at increasing hemoglobin to Evidence Based Practice Guidelines target levels. Those results were presented at the 10th Congress of the European Hematology Association in Stockholm, Sweden. Amgen submitted last month a supplemental biologics license application for Aranesp as a once-every-three-weeks treatment for anemia in patients with non-myeloid malignancies.

• Applied Biosystems Group, of Foster City, Calif., and Invitrogen Corp., of San Diego, reported a co-marketing and reselling alliance to deliver solutions for proteomic analyses and biomarker studies in drug discovery and disease research worldwide. The companies will resell a combined suite of labeling technologies consisting of Applied Biosystems' suite of protein and peptide labeling technologies - iTRAQ and ICAT reagents - and Invitrogen's newly launched SILAC metabolomic labeling technology.

• Argonaut Technologies Inc., of Redwood City, Calif., closed the sale of the assets of its chemistry consumables business and certain assets of its process chemistry business, which constitute substantially all of its assets except for its cash, to Biotage AB, of Uppsala, Sweden. As a result of the transaction, the company no longer has an operating business and plans to wind-up its assets and liabilities.

• Avanir Pharmaceuticals Inc., of San Diego, presented data at the 105th general meeting of the American Society for Microbiology in Atlanta, demonstrating that its fully human monoclonal antibody, AVP 21D9, protected rabbits against inhalation anthrax at one dose. Data also showed that AVP 21D9 worked with the antibiotic ciprofloxacin to protect mice and guinea pigs.

• AVI BioPharma Inc., of Portland, Ore., presented positive results from two preclinical studies at the 87th annual meeting of the Endocrine Society in San Diego. The presentations discussed application of Neugene antisense drugs for treating prostate cancer and overcoming chemotherapy resistance in ovarian cancer.

• Azaya Therapeutics Inc., of San Antonio, appointed Michael Dwyer president, CEO and member of the company's board. Dwyer most recently served as senior vice president and chief administrative officer at Ingenix Pharmaceutical Services, of Parsippany, N.J., a global contract research subsidiary of UnitedHealth Group, and previously held executive management positions at ILEX Oncology Inc., of San Antonio.

• BioCrossroads, of Indianapolis, formed Indiana Seed Fund I, a seed-stage, pre-venture capital fund designed to promote business formation and growth in the state's life sciences sector. The $4 million Seed Fund will provide working capital in the range of $50,000 to $500,000 to promising Indiana life sciences companies at preliminary stages of operation.

• Bioenvision Inc., of New York, said its cancer drug, clofarabine, approved for relapsed/refractory acute lymphoblastic leukemia in children, demonstrated efficacy as a first-line treatment of acute myeloid leukemia in adults in Phase II study. Those results were presented at the 10th European Hematology Association meeting in Stockholm, Sweden.

• BioVex Inc., of Cambridge, Mass., relocated its headquarters from the UK to Cambridge. BioVex will base its clinical, finance and business development operations in Massachusetts. The company will retain its research function in the UK. Philip Astley-Sparke, president and chief financial officer of BioVex, will serve as operational head in the U.S. The company also reported that it received approval from the FDA to begin a Phase II trial in malignant melanoma with OncoVEX, its lead product for the treatment of solid tumors.

• Celgene Corp., of San Diego, said further analysis of data from an ongoing Phase II study of Revlimid in patients with low and intermediate-1 risk myelodysplastic syndromes showed that 84 of 166 patients (51 percent) have responded to treatment, while 54 patients (33 percent) became transfusion independent, defined as eight consecutive weeks or more without requiring a blood transfusion and a 1 g/dl or greater rise in hemoglobin. Results were presented at the 10th Congress of the European Hematology Association in Stockholm, Sweden.

• Cerus Corp., of Concord, Calif., entered a definitive agreement with BioOne Corp., of Tokyo, for commercialization of the Intercept Blood System for plasma in parts of Asia. BioOne will market and distribute the Intercept Blood System for plasma in Japan, China, Taiwan, South Korea, Thailand, Vietnam and Singapore. Cerus has received an up-front payment of $3 million for signing the letter of intent. It also can receive up-front and milestone payments totaling about $33 million in cash and BioOne equity, as well as royalties.

• Cleveland Clinic in Cleveland said its researchers identified the first gene in patients who have epilepsy associated with a movement disorder called paroxysmal dyskinesia. The clinic said that the first direct genetic evidence that the co-existence of those conditions represents a new syndrome. Complete research findings appeared June 5, 2005, in the online version of Nature Genetics and in the July print edition.

• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., reported positive outcomes from two Phase III trials evaluating Oracea for the treatment of rosacea. A total of 537 patients were administered Oracea or placebo once daily for 16 weeks, and both studies achieved their primary endpoints, as determined by the reduction of inflammatory lesion count. The company said patients receiving Oracea experienced a 61 percent and 46 percent mean reduction in lesions, compared to 29 percent and 20 percent, respectively, in patients receiving placebo. The drug also demonstrated statistical significant in secondary endpoints by showing an improvement according to the investigators' global assessment scores, which measures overall disease severity.

• Depomed Inc., of Menlo Park, Calif., entered a development and license agreement with New River Pharmaceuticals Inc., of Radford, Va., to create pharmaceutical products using Depomed's oral drug delivery technology with New River's drug compounds. The use of Depomed's gastric retention system should allow New River to develop extended-release formulations of its products in certain therapeutic areas. New River will hold worldwide rights to the technology in up to three of its compounds, and reimburse Depomed on a cost-plus basis for expenses. Depomed also is entitled to milestone payments and royalties on any commercialized products.

• Genentech Inc., of South San Francisco, said data were presented at the Endocrine Society 87th annual meeting in San Diego, featuring the need for a shift in the treatment paradigm of pediatric/adult growth hormone deficient patients and reinforcing the importance of long-term safety and efficacy data using recombinant human growth hormone therapy. The company's Nutropin was introduced in 1993 for several indications, including long-term treatment of children with growth failure due to lack of endogenous growth hormone secretion and as a replacement of endogenous growth hormone.

• Inhibition Therapeutics Inc., of Englewood, Colo., said its stock symbol on the Over-the-Counter Bulletin Board has changed, from "OSLC" to "IHBT," and that is has recently completed the acquisition of all the issued and outstanding stock of Inhibetex Therapeutics Inc. Inhibition Therapeutics focuses on developing technologies and products to target cancer.

• Introgen Therapeutics Inc., of Austin, Texas, said preclinical findings of its cancer compound INGN 241 alone or in combination with other therapeutic modalities in breast, pancreatic and ovarian cancer demonstrated that expression of the mda-7 tumor-suppressor gene, the active component of INGN 241, increased cancer cell death and stimulated systemic immunity against cancer. The drug is being evaluated in a Phase II study in patients with malignant melanoma. Introgen also presented data from its INGN 007 program in oncolytic viruses for the treatment of cancer, which show that the drug has a favorable safety profile and significantly inhibits primary tumor growth, as well as metastatic disease. Results from those studies were presented at the American Society of Gene Therapy's annual meeting in St. Louis.

• Kosan Biosciences Inc., of Hayward, Calif., initiated a company-sponsored multicenter Phase I trial of KOS-1022 in patients with advanced hematologic malignancies. The company also reported that the U.S. Patent & Trademark Office granted Patent No. 6,890,917 B2 covering the KOS-1022 composition of matter and its use for treating a range of cancers. The company is the exclusive licensee of the patent in those fields and others. KOS-1022 is a second-generation Hsp90 inhibitor.

• Lev Pharmaceuticals Inc., of New York, completed a private placement of about 5 million shares of its common stock and 2.5 million warrants. The securities were sold as a unit at a price of $50,000 per unit for aggregate gross proceeds of about $5 million. Each unit consisted of 50,000 shares of common stock and a warrant to purchase 25,000 shares of common stock. The warrants are immediately exercisable at any time within five years through the date of issuance. Laidlaw & Co. Ltd. acted as placement agent.

• Ligand Pharmaceuticals Inc., of San Diego, earned a $2 million milestone payment from GlaxoSmithKline plc, of London, for filing an investigational new drug application for SB-559448 for thrombocytopenia. Ligand is entitled to further milestone payments and double-digit royalties on product sales.

• Medicago Inc., of Quebec, said it formed a multiyear co-development collaboration with Little Rock, Ark.-based InterveXion Therapeutics Inc. to use Medicago's Proficia Protein Technology for the production of monoclonal antibodies designed to treat drug abuse. InterveXion has received a $3 million grant to conduct clinical trials for the first antibody treatment for addiction to the drug phencyclidine (PCP) from the National Institutes of Health's Institute on Drug Abuse. Under terms of the collaboration, Medicago will receive milestone payments to produce the PCP antibody for the completion of the necessary trials.

• Myogen Inc., of Denver, filed a shelf registration statement to sell from time to time up to $125 million in common stock, preferred stock, depository shares, debt securities or warrants. Myogen is focused on the discovery, development and commercialization of small-molecule therapeutics for the treatment of cardiovascular disorders. It has three products in late-stage clinical development, including enoximone capsules for advanced chronic heart failure, ambrisentan for pulmonary arterial hypertension, and darusentan for resistant hypertension.

• Neuren Pharmaceuticals Ltd., of Auckland, New Zealand, said the clinical trial program for its lead drug, Glypromate, to prevent the loss of brain function following coronary artery bypass grafting surgery, has been shortened following a pre-investigational new drug meeting with the FDA. The company will proceed directly to a major efficacy study after completing a small Phase IIa trial by the end of the year and other standard prerequisites for Phase III. Neuren will avoid the cost of a previously planned Phase IIb study, and the Phase III can begin in 2006 rather than 2008, it said.

• Neurochem Inc., of Laval, Quebec, said further analysis of its Phase II/III study for the AA amyloidosis drug Fibrillex was presented at the European Renal Association-European Dialysis and Transplant Association meeting in Istanbul, Turkey. The most recent analysis takes into account both the number of events and the time to reach such an event, showing that Fibrillex reduced the risk of renal decline or all-cause mortality by 42 percent. The company announced in April that Fibrillex missed the primary endpoint. (See BioWorld Today, April 19, 2005.)

• Oscient Pharmaceuticals Corp., of Waltham, Mass., completed preliminary data analysis of its pivotal Phase III trial examining the potential use of Factive (gemifloxacin mesylate) tablets for the five-day treatment of mild to moderate community-acquired pneumonia. The study, which compared the five-day dosing to the FDA-approved seven-day dosing, achieved its primary endpoint. The company plans to submit the data to the FDA by the end of 2005 and seek a label expansion for Factive.

• Oxford BioMedica plc, of Oxford, UK, signed a license agreement for its LentiVector technology with New York-based Pfizer Inc. Oxford BioMedica will receive an up-front license payment and an annual maintenance fee. The technology is used for gene target validation in the drug discovery process, as well as for direct therapeutic applications in neurotherapy.

• Portola Pharmaceuticals Inc., of South San Francisco, entered a license agreement to advance the development of a series of promising preclinical compounds developed by Astellas Pharma Inc., of Tokyo. Astellas was formed through a merger earlier this year between Fujisawa Pharmaceutical Co. Ltd. and Yamanouchi Pharmaceutical Co. Ltd. Portola has identified the anti-thrombotic properties of Astellas compounds, which inhibit platelet adhesion to arterial walls.

• Tercica Inc., of San Diego, presented data at the 87th annual meeting of the Endocrine Society for recombinant human insulin-like growth factor-1 (rhIGF-1; Increlex) to treat short stature caused by primary IGF-1 deficiency. The company's new drug application was accepted by the FDA for priority review in April. The data included results from a human pharmacokinetic study, as well as human and animal safety data showing no evidence of immunotoxic effects with long-term rhIGF-1 treatment.

• Theratechnologies Inc., of Montreal, said data involving its lead product, TH9507, demonstrated a favorable effect on the atherogenic lipid profile in various study populations, and call for further investigation in clinical conditions associated with increased cardiovascular risk, such as HIV-associated lipodystrophy and the metabolic syndrome. Those results were presented at the 87th annual meeting of the Endocrine Society in San Diego. TH9507 is a stabilized analogue of the growth hormone-releasing factor that induces the production and secretion of growth hormone in a specific, physiological, controlled and pulsated fashion. Theratechnologies also presented data on early-stage Type II diabetes compounds, including glucagon-like peptide-1, which has shown that it induces insulin secretion in a glucose-dependent manner.