• Aastrom Biosciences Inc., of Ann Arbor, Mich., said its lead U.S. clinical trial of its bone-generation, tissue-repair cell, adult stem cell product was initiated at a second site, the University of Michigan Health System in Ann Arbor. The trial is to be conducted at the university's orthopedic trauma center. As many as 20 patients could be treated who have either long-term (a minimum of eight months) non-healing tibial leg fractures or tibial non-union fractures that are severe enough to require a bone graft to aid repair.

• Applied Biosystems Group, of Foster City, Calif., expanded its TaqMan SNP Genotyping Assays for functional genomics research. The assays include an inventory of more than 30,000 TaqMan Coding SNP Genotyping Assays for researchers studying single nucleotide polymorphisms within protein-coding regions of genes, and more than 1.8 million TaqMan Pre-Designed SNP Genotyping Assays that can be made to order.

• Archemix Corp., of Cambridge, Mass., and Nuvelo Inc., of Sunnyvale, Calif., submitted an investigational new drug application to the FDA to begin a Phase I trial of the thrombin inhibitor ARC183 for potential use in coronary artery bypass graft surgery. ARC183 is an anti-thrombin aptamer. The Phase I trial is expected to begin in the second half of this year. In January, Archemix and Nuvelo entered a collaboration to develop and commercialize ARC183.

• AVI BioPharma Inc., of Portland, Ore., terminated its license agreement with Medtronic Inc., of Minneapolis, for the delivery of AVI's antisense therapy, Resten-NG, via medical devices, including stents and catheters. AVI and Medtronic first entered an agreement to develop Resten-NG for stent and catheter delivery in 2001, and they modified the agreement in September. AVI regains full exclusive rights to development of Resten-NG in all cardiovascular applications, including device delivery. Resten-NG works by inhibiting c-myc expression.

• Axonyx Inc., of New York, was added to the Russell 3000 Index. Annual reconstitution of the Russell indices captures the 3,000 largest U.S. stocks as of the end of May. The company's lead Alzheimer's disease drug candidate is Phenserine, a dual-action acetylcholinesterase and beta-amyloid precursor protein inhibitor that is in Phase IIb and Phase III trials.

• Berlex Inc., of Montville, N.J., began recruitment for two Phase III trials of Leukine (sargramostim) for Crohn's disease. The growth-factor studies are part of NOVEL. (New Opportunities to Verify Evolving Logic in Crohn's disease), which will include more than 1,000 patients. Berlex, which last year reported plans for Phase III trials of the long-approved cancer drug in the new indication, is a U.S. affiliate of Schering AG, of Berlin. (See BioWorld Today, Aug. 29, 2003.)

• BioCryst Pharmaceuticals Inc., of Birmingham, Ala., was added to the Russell 3000 Index at the close of the market on June 25. Membership in the Russell 3000 means automatic inclusion for BioCryst in the small-cap Russell 2000 Index. BioCryst is focused on drugs that block enzymes involved in cancer, viral infections and cardiovascular and autoimmune diseases.

• BioDiscovery Inc., of El Segundo, Calif., reported an OEM supply agreement with Bio-Rad Laboratories Inc., of Hercules, Calif., for worldwide distribution of microarray analysis software. BioDiscovery is a provider of software products for bioanalysis and, in particular, products for quantification and statistical evaluation of gene-expression results, including its software systems ImaGene and GeneSight.

• BioWa Inc., of Princeton, N.J., granted a commercial license to Biogen Idec Inc., of Cambridge, Mass., to use its Potelligent Technology for the enhancement of antibody-dependent cellular cytotoxicity. Biogen Idec plans to use the technology to enhance the ADCC function of selected antibodies for potential therapeutic applications, including cancer. The agreement provides Biogen Idec with the right to reserve exclusive commercial rights to develop antibodies for an undisclosed number of targets. BioWa will receive a signing fee, and could receive milestone payments and royalties on products developed by Biogen Idec.

• Can-Fite Biopharma Ltd., of Petach-Tikva, Israel, began a Phase I trial of CF101 in the U.S. in patients with solid tumors. Researchers at three Harvard Medical School-affiliated hospitals will investigate combinations of CF101 with three standard chemotherapeutic regimens. The primary objective will be to determine the safety, tolerability and clinical effects of the oral administration of the combination therapy.

• Cardiome Pharma Corp., of Vancouver, British Columbia, received notice from the Nasdaq Stock Market that its common shares will begin trading under the symbol "CRME" Tuesday. Cardiome shares will continue to trade on the Toronto Stock Exchange in addition to Nasdaq. Cardiome has three late-stage clinical drug programs focused on atrial arrhythmias, congestive heart failure and hyperuricemia.

• Cephalon Inc., of West Chester, Pa., reached an agreement in principle with the Federal Trade Commission to close its proposed $515 million merger with CIMA Labs Inc., of Eden Prairie, Minn. As a result, both companies decided not to exercise their respective rights to terminate the merger agreement and intend to close the transaction as soon as possible, they said. (See BioWorld Today, Nov. 5, 2003.)

• CuraGen Corp., of New Haven, Conn., and TopoTarget A/S, of Copenhagen, Denmark, began a Phase I trial of PXD101 in patients with hematologic cancer and solid-tumor cancers. The trial complements the ongoing Phase I study in cancer patients with solid tumors initiated in 2003. The study is a dose-escalating, open-label trial expected to enroll about 15 patients.

• CyDex Inc., of Lenexa, Kan., agreed to license its Captisol drug-formulation system to TargeGen Inc., of San Diego, for use with a drug under development, TG 100-115, for acute myocardial infarction. The compound is expected to enter the clinic in the second half of this year. CyDex also granted similar licensing terms to TargeGen for use of Captisol with additional compounds developed in the next five years. At the same time, TargeGen designated TG 100-435 a lead drug for clinical development in oncology and edema indications. The company said it is hopeful that by late next year, TG 100-435 will be its second compound in the clinic. Financial terms were not disclosed.

• Discovery Laboratories Inc., of Doylestown, Pa., began trading its common stock Wednesday on the Nasdaq National Market under the symbol "DSCO." Discovery Lab's stock previously traded on the Nasdaq SmallCap Market. Discovery Labs is developing its surfactant technology as replacement therapies for respiratory diseases.

• Geron Corp., of Menlo Park, Calif., said Kyowa Hakko Kogyo Co. Ltd., of Tokyo, returned Asian territory development and marketing rights for Geron's telomerase inhibitors. Geron has two compounds in preclinical development that Kyowa helped develop. Kyowa plans to focus on other oncology platforms. Geron plans to soon file an investigational new drug application for GRN163L for a hematologic cancer indication.

• GPC Biotech AG, of Martinsried, Germany, priced its global offering at €12 (US$14.55) per American depository share, raising net proceeds of $95.3 million. The offering consisted of a rights offering to existing holders of GPC's shares; a global offering, including public offerings in Germany and the U.S.; and private placements in other jurisdictions. GPC offered a total of about 7.5 million shares, 2.6 million in the rights offering and 4.5 million in the global offering. GPC also granted underwriters an option to purchase up to an additional 1.1 million shares to cover overallotments. If exercised, the company will have raised a total of $110.6 million. Goldman, Sachs & Co. served as global coordinator and bookrunner, while Lehman Brothers Inc. was a joint-lead manager. Pacific Growth Equities LLC and WestLB AG served as co-lead managers.

• Hawaii Biotech Inc., of Honolulu, said its West Nile vaccine protected 100 percent of test animals from both illness and death when challenged with the virus, while 53 percent of the control animals died. The study's results validate data from last year of the sub-unit vaccine. The company's genetically engineered vaccine technology is designed to offer a safer, non-infectious alternative to traditional live-virus vaccines.

• Interleukin Genetics Inc., of Waltham, Mass., signed an agreement with Tufts University for exclusive rights to develop and commercialize tests and nutritional products based on variations in the perilipin gene that have been associated with body-weight differences. Perilipin is a protein in fat cells that influences fat metabolism. Interleukin might also use the gene variations to develop nutritional products that modulate the effects of those variations.

• Introgen Therapeutics Inc., of Austin, Texas, said an article in this month's issue of International Immunopharmacology reviews the multiple anticancer activities of mda-7, the active component of INGN 241. Data showed that secretion of mda-7 protein out of a cell elicits multiple indirect anticancer responses by stimulating the immune system, inhibiting the growth of new blood vessels essential for tumor growth and activating cell-death pathways in neighboring cells that express the mda-7 receptor. Due to the activity of secreted mda-7, INGN 241 might produce systemic anticancer effects following local administration. The company is evaluating the compound in a Phase II melanoma trial.

• Maxim Pharmaceuticals Inc., of San Diego, said its stock was added to the Russell 2000 Index. The annual reconstitution of Russell's 21 U.S. equity indices captures the 3,000 largest U.S. stocks, ranking them by market capitalization to create the market Russell 3000 index. Maxim has a pipeline of therapeutic candidates for cancer and liver diseases.

• Merck KGaA, of Darmstadt, Germany, said Erbitux (cetuximab) received European approval for metastatic colorectal cancer. More specifically, the monoclonal antibody was licensed for use in combination with irinotecan for patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer after failure of irinotecan, including cytotoxic therapy. Erbitux will be available in all 25 member states of the European Union, as well as Iceland and Norway. Approved earlier this year by the FDA, U.S. sales are booked by ImClone Systems Inc. and Bristol-Myers Squibb Co., both of New York. ImClone noted that it would build on the recent global regulatory approvals by continuing clinical development of Erbitux in earlier-stage colorectal cancer and other tumor types. The approval was expected, said Banc of America Securities Analyst Michael King, who added that ImClone receives a 5 percent royalty on European sales. (See BioWorld Today, Feb. 13, 2004.)

• Modular Genetics Inc., of Woburn, Mass., closed the first round of a $5.5 million Series B financing. The company said it would use proceeds to enhance its automated gene-engineering system, expand the sales force and accelerate product development programs. Its technology is used for automated assembly and modification of cloned genes.

• Nabi Biopharmaceuticals, of Boca Raton, Fla., exercised its option to acquire full rights to Aloprim (Allopurinol sodium [for injection]) from DSM Pharmaceuticals Inc., of Greenville, N.C. The drug, the only intravenous form of allopurinol marketed in the U.S., is used to help control elevated uric acid levels (hyperuricemia) in leukemia, lymphoma or solid organ tumor patients who are not able to tolerate oral allopurinol. Nabi has had U.S. distribution rights to Aloprim since 1999, when it acquired them from Catalytica Pharmaceuticals Inc., also of Greenville. Financial terms were not disclosed.

• North American Scientific Inc., of Chatsworth, Calif., said findings reported at the Society of Nuclear Medicine meeting in Philadelphia suggest that use of its Hynic-Annexin V product candidate for imaging could reduce the number of patients receiving futile platinum-based chemotherapy by as much as 80 percent. The ongoing European trial that produced the data is being conducted by its Theseus Imaging subsidiary.

• Palatin Technologies Inc., of Cranbury, N.J., and scientists at Concordia University in Montreal published a manuscript in the Proceedings of the National Academy of Sciences detailing the results of preclinical studies evaluating the effects of PT-141 on the sexual behavior of female rats. PT-141, Palatin's lead drug for male and female sexual dysfunction, increased the number of solicitations performed by the female in the presence of a male partner. The effect showed a dose response and did not affect the copulation behavior of the females.

• Peplin Biotech Ltd., of Brisbane, Australia, said investigational new drug applications for PEP005 Topical were filed with the FDA by its development partner, Allergan Inc., of Irvine, Calif. The compound is a topical formulation of its lead compound, PEP005. The applications are for the treatment of the pre-cancerous condition actinic keratosis and basal-cell carcinoma. The filings, which amend applications originally filed by Allergan in March, incorporate a more comprehensive Phase I/II program. Initial studies will evaluate the topical formulation's safety. Allergan will focus its early efforts in actinic keratosis and basal-cell carcinoma and await results from its initial studies before pursuing a program in squamous-cell carcinoma.

• Phase III Medical Inc., of Melville, N.Y., said its partner, Parallel Solutions Inc., of Cambridge, Mass., would begin in vivo animal studies after conducting in vitro evaluation studies of Phase III's library of polyphosphazene polymers. Parallel Solutions is conducting a proof-of-concept study for the development of a new bioshielding platform technology for the delivery of therapeutic proteins.

• Point Therapeutics Inc., of Boston, initiated a Phase II trial of talabostat (PT-100) to treat advanced metastatic melanoma. The study is designed as a single-arm study in up to 30 patients to evaluate the antitumor activity of the drug as a single agent. The primary clinical endpoint will be overall tumor response. Secondary endpoints include response rates at the mid-point of the study, as well as complete response rate, duration of tumor response, time to disease progression and survival.

• ProtoKinetix Inc., of Vancouver, British Columbia, entered an agreement to purchase antifreeze glycoprotein (AFGP) from Perigene Inc., of Compeigne, France. AFGP is a natural compound that enables fish, reptiles and insects to survive freezing temperatures. A scientist at ProtoKinetix has synthesized the AFGP molecule in a stable form. Financial terms were not disclosed.

• Serologicals Corp., of Atlanta, entered a definitive agreement to acquire AltaGen Biosciences Inc., of Morgan Hill, Calif., the parent company of Sierra BioSource. AltaGen and its Sierra BioSource subsidiary offer research and development services in the areas of cellular and molecular biology, immunology, animal pharmacology, monoclonal antibodies and recombinant proteins. Terms were not disclosed. The acquisition is expected to close in the third quarter.

• Symyx Technologies Inc., of Santa Clara, Calif., and the Dow Chemical Co., of Midland, Mich., extended their research and development collaboration. The collaboration will continue to focus on the discovery of catalysts to produce polyolefins, which are polymers used in a variety of industrial and consumer plastic products. The extension runs through Dec. 31. Symyx develops and applies high-throughput experimentation to the discovery of materials for the chemical life science and other industries. Symyx also agreed to sell its Discovery Tools to North Dakota State University, which will use the products as part of a program to synthesize, test and evaluate polymers and coatings formulations for applications including the discovery of marine coatings through support from the Office of Naval Research of the U.S. Department of Defense.

• Telik Inc., of Palo Alto, Calif., began a new Phase II trial of Telcyta (TLK286) in combination with carboplatin and paclitaxel in the front-line treatment of Stage IIIb or IV non-small-cell lung cancer. The trial will enroll about 50 patients who have not previously received chemotherapy. It will be conducted at teaching affiliates of the Harvard Medical School.

• Tularik Inc., of South San Francisco, said it would hold a special meeting of stockholders Aug. 12 to vote on its proposed $1.3 billion acquisition by Amgen Inc., of Thousand Oaks, Calif. Terms call for Amgen to exchange Tularik common stock for Amgen common stock in a ratio that fixes Tularik's value at $25 per share, based on the average Amgen stock price during a set number of trading days prior to the close of the transaction. (See BioWorld Today, March 30, 2004.)

• Unigene Laboratories Inc., of Fairfield, N.J., said its oral delivery technology is featured in the June issue of BioPharm International. The article identifies degradation in the digestive tract as the primary obstacle that must be overcome in order to make oral delivery of peptide drugs possible. Unigene's calcitonin formulation has demonstrated in human studies its ability to deliver therapeutic amounts of calcitonin into a patient's bloodstream.

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