• AltaRex Corp., of Edmonton, Alberta, closed its previously reported financing. At closing, a total of 6 million units, including units issued upon the exercise of the agents' overallotment option, were issued for aggregate gross proceeds of about $2 million. Each unit consists of one common share and one common share purchase warrant. Each warrant entitles the holder to acquire, on or before Oct. 20, 2004, one common share of AltaRex upon payment of 50 cents per share. After giving effect to the transaction, AltaRex has 51.9 million common shares issued and outstanding.

• Amgen Inc., of Thousand Oaks, Calif., and Wyeth Pharmaceuticals, a division of Wyeth, of Madison, N.J., received FDA approval for once-weekly dosing of Enbrel (etanercept). The expanded approval includes a 50-mg, once-weekly dose of Enbrel for adult patients across all indications - including moderately to severely active rheumatoid arthritis, active arthritis in patients with psoriatic arthritis and active ankylosing spondylitis - and a 0.8-mg/kg, once-weekly dose (maximum 50 mg per week) for 4- to 17-year-old patients with moderately to severely active juvenile rheumatoid arthritis. Amgen said the approval allows such patients to benefit from the product's long-term efficacy and tolerability with the convenience of once-weekly dosing.

• Applied Molecular Evolution Inc., of San Diego, achieved a milestone in its collaboration with Centocor Inc., of Malvern, Pa., to optimize a therapeutic antibody candidate. AME provided a panel of optimized antibody candidates to Centocor with improvements in both potency and affinity that met or exceeded the critiera specified in the collaboration agreement. Financial terms of the milestone were not disclosed.

• AtheroGenics Inc., of Atlanta, initiated enrollment in a Phase II trial of AGIX-4207 in patients with rheumatoid arthritis. The multicenter, double-blind trial will enroll about 220 patients, who will be randomized into four groups and treated with one of three oral doses or placebo once a day for 12 weeks. The primary endpoint is a reduction in the clinical signs and symptoms of disease. The trial also will assess various secondary endpoints, including biological markers, safety and tolerability, and time to initiation of rescue medication.

• Avanir Pharmaceuticals Inc., of San Diego, reported interim results showing that single rising doses of its experimental asthma and allergy drug, AVP 13358, were well tolerated in a Phase I trial for safety and bioavailability. The orally active compound's bloodstream presence was demonstrated at all four oral dose levels from 1 mg to 5 mg.

• BioCrossroads, central Indiana's life sciences initiative, said the Indiana Future Fund I was established by a coalition of institutional investors to invest in regional and national venture capital funds. The $72 million capital pool is designed to encourage direct investment in the Hoosier State's life sciences opportunities. Organized through BioCrossroads, and managed by Credit Suisse First Boston, the fund includes investments by Indiana's public pension funds: Eli Lilly and Co., Anthem Blue Cross and Blue Shield, Indiana University, Indiana University Foundation, Purdue University, Ball State University Foundation, American United Life Insurance Co., Indiana State University Foundation and Guidant Corp.

• Bioniche Life Sciences Inc., of Belleville, Ontario, said feedlot cattle vaccinated with an E. coli O157 vaccine during the summers of 2002 and 2003 showed a 59 percent reduction of the bacteria in their manure, according to University of Nebraska researchers who conducted the studies. Also, E. coli prevalence averaged less than 11 percent for vaccinated cattle compared with 29 percent among unvaccinated cattle. At market weight, 84 days after vaccination, 19 percent of vaccinated cattle were shedding E. coli O157:H7 compared with nearly 41 percent of unvaccinated cattle. It stock (TSX:BNC) jumped C43 cents Tuesday, or 20.8 percent, to close at C$2.50 (US$1.90).

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., reported Phase II data at this week's International Society for the Study of Women's Sexual Health meeting in Amsterdam, the Netherlands, showing that treatment with LibiGel (topical testosterone gel) for female sexual dysfunction produced statistically significant results for the ongoing study's primary endpoints. After three months of treatment in the U.S.-based study, patients recorded a 130 percent increase from baseline (p<0.01) in the frequency of satisfying sexual events as measured by individual patient diaries. There also was a 136 percent increase from baseline (p<0.01) in sexual desire as measured by the Brief Index of Sexual Functioning for Women.

• Coley Pharmaceutical Group Inc., of Wellesley, Mass., received a $5.8 million grant from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health in Bethesda, Md., to support development of inhaled drug products for broad-spectrum defense against bioterrorism agents. The funds will be used for basic research and preclinical studies of Coley's immunostimulatory CpG TLR9 agonists.

• Cortex Pharmaceuticals Inc., of Irvine, Calif., said preliminary results from testing Ampakine CX516 at the Medical University of South Carolina showed a positive dose-related response on performance deficits in healthy male subjects after sleep deprivation. A total of 10 young, healthy men were administered three different doses of CX516 or a placebo. All were sleep deprived for 31 hours before they received the drug or placebo. Researchers plan to test a higher dose in continued studies.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., said its recent follow-on public offering grossed more than $90 million, a 20 percent increase over the original shelf registration statement filed with the SEC, as the offering's underwriters fully exercised their overallotment option to purchase about 1.1 million shares at $10.50 apiece. The offering, which initially included about 7.5 million shares sold at the same price, resulted in net proceeds of $84.6 million. The transaction's sole bookrunner was Morgan Stanley & Co. Inc. Co-lead manager was Pacific Growth Equities LLC. Other co-managers included WR Hambrecht + Co. LLC and Harris Nesbitt Gerard Inc. (See BioWorld Today, Oct. 17, 2003.)

• Flamel Technologies SA, of Lyon, France, said it would terminate a license agreement with GlaxoSmithKline plc, of London, as of Jan. 14. The arrangement related to a sachet formulation of augmentin, incorporating Flamel's Micropump technology, originally being developed in partnership with Beecham Pharmaceuticals Pty Ltd. The company added that GlaxoSmithKline decided to stop the project for commercial reasons. Flamel also noted that the decision did not stem from adverse performance or other issues related to its technology, and it plans to continue to collaborate with GlaxoSmithKline in developing a once-a-day Coreg formulation.

• Generex Biotechnology Corp., of Toronto, reported data from studies sponsored by the company and presented last week at the Canadian Diabetes Association/Canadian Society of Endocrinology and Metabolism professional conference and annual meetings in Ottawa, Ontario. The studies address the efficacy of its Oralin oral insulin spray formulation and RapidMist Diabetes Management System in treating Type I diabetes. There were no statistically significant differences on three different occasions in Oralin absorption. Oralin showed faster onset of action and reached peak level within 50 to 70 minutes and was comparable to rapid insulin. The subcutaneous regular injected insulin on average was slower in action and reached peak levels around 90 minutes to 100 minutes.

• Guava Technologies Inc., of Hayward, Calif., said that with its ViaCount Flex assay reagent, absolute cell count and viability assessments can now be done with insect and other nonmammalian cells. Guava's reagent is designed to accelerate work in vaccine research and commercial vaccine production, as well as in studies of insect pathology and disease states.

• High Throughput Genomics Inc., of Tucson, Ariz., and ProSkelia SAS, of Paris, reported that ProSkelia will incorporate HTG's ArrayPlate high-throughput screening technology into one of its drug discovery programs. HTG's ArrayPlate contains a generic Universal Array in each well of a standard 96-well microplate. Each array can be programmed using reagents, either by HTG or by the customer, for the measurement of any set of up to 100 DNA, RNA or protein molecules.

• Iconix Pharmaceuticals Inc., of Mountain View, Calif., said that Millennium Pharmaceuticals Inc., of Cambridge, Mass., selected Iconix to provide advanced chemogenomic profiling and analytical services for specific Millennium drug discovery programs, including the application of specific Iconix biomarkers for drug optimization. Millennium will apply Iconix's chemogenomics platform to enhance its drug candidate selection and optimization. Iconix will use biomarkers of drug pathology and mechanism from its Drug Signature library, a collection of predictive biomarkers.

• IsoTis SA, of Lausanne, Switzerland, transferred its orthobiology research group to the University of Twente in the Netherlands. The group will become part of the school's Biomedical Technology Institute, with two of the company's scientific founders heading the new group, which will focus on the biology and repair of musculoskeletal tissues. In return for providing financial support, IsoTis will own resulting technology or products to secure the inflow of new technology into its product pipeline. Financial terms were not disclosed.

• Keryx Biopharmaceuticals Inc., of New York, began a multicenter Phase II/III trial of KRX-101 to treat diabetic nephropathy. The study will compare two doses, 200 mg and 400 mg daily, vs. placebo. It is designed to assess the safety and efficacy of KRX-101 in patients with Type II diabetes who continue to have persistent microalbuminuria despite treatment with maximum approved doses of standard therapies, including ACE inhibitors or A2 receptor blockers. The trial will evaluate the drug's ability to impact urinary protein excretion in the study population. Patients will be treated for six months, then evaluated for another two months. Between 750 and 1,000 patients will be enrolled, with the Phase II component taking about six to nine months and the Phase III component taking an additional 12 to 15 months. Keryx's stock (NASDAQ:KERX) gained 96 cents Tuesday, or 21.3 percent, to close at $5.46.

• Lexicon Genetics Inc., of The Woodlands, Texas, said that in an article published in the October 2003 issue of Current Opinion in Pharmacology, its scientists reviewed gene knockouts for targets of pipeline drugs of the top 10 pharmaceutical companies. The analysis revealed that mouse knockout phenotypes provide a biological rationale for the selected disease indication for more than 85 percent of drugs currently in development. Lexicon scientists are focused on discovering drugs by first knocking out and analyzing the genes that encode future potential drug targets.

• Neose Technologies Inc., of Horsham, Pa., said it plans to develop an improved, GlycoPEGylated version of granulocyte colony-stimulating factor (G-CSF) expressed in E. coli as its second protein candidate. G-CSF is a protein used for the treatment of neutropenia.

• Panacos Pharmaceuticals Inc., of Gaithersburg, Md., reported the publication of a study elucidating the mechanism of action of its lead drug candidate, PA-457, in development for the treatment of HIV infection. Panacos researchers demonstrated that PA-457 disrupts viral maturation, the final step in the HIV life cycle. Maturation involves the processing of the HIV capsid protein, which is required for the formation of a functional core structure within the virus. PA-457 blocks capsid processing so that virus particles released from treated cells have a defective core structure, are noninfectious and therefore cannot spread the infection to other cells.

• Sepracor Inc., of Marlborough, Mass., reported that data from its six-month Phase III study of Estorra brand eszopiclone for the treatment of chronic insomnia were published in the journal Sleep. Patients from 21 years to 69 years of age with chronic insomnia received nightly treatment with either placebo (n=195) or eszopiclone 3 mg (n=593). Results demonstrated that nightly use of eszopiclone 3 mg resulted in statistically significant improvement compared with placebo on patient-reported measures of sleep onset, sleep maintenance and sleep quality.

• TaiGen Biotechnology Co. Ltd. and TTY Biopharm Co. Ltd., both of Taipei, Taiwan, signed an agreement to jointly develop and market a novel topoisomerase-I inhibitor, DB67, for cancer. DB67 was discovered and patented by researchers at the University of Pittsburgh. National Health Research Institutes of Taiwan licensed the Asian rights of DB67, assigning them to TTY for development and commercialization. TaiGen will conduct studies in the areas of animal disease models, pharmacokinetics, drug metabolism and toxicology, and TTY in formulation, GMP production of dosage forms and organization of clinical trials. The companies plan to market the drug jointly in Asia.

• Telik Inc., of Palo Alto, Calif., reported positive interim results from a trio of Phase I/IIa studies using escalating doses of Telcyta coupled with various other drugs. A combination with carboplatin in patients with platinum-refractory or -resistant ovarian cancer resulted in an overall disease stabilization rate of 88 percent. Five of the eight evaluable patients have objective tumor responses, including one complete response, and enrollment and dose escalation continues. Addiotional interim results from a trial in patients with Stage IIIB or IV non-small-cell lung cancer who failed prior platinum-based therapy suggest that Telcyta and docetaxel might be administered in combination using the full dose of each drug. Findings from a study of Telcyta and Doxil in patients with platinum-refractory or -resistant ovarian cancer suggest that the combination regimen could use the full dose of each drug. Enrollment and treatment in the latter two studies continue at the full dose level.

• Tercica Inc., of South San Francisco, set the price range for its initial public offering at $14 to $16 and its number of shares at 5 million. The company, which is developing treatments for endocrine disorders related to growth problems and diabetes, filed for its IPO last month, seeking $86.25 million. (See BioWorld Today, Sept. 15, 2003.)

• Theratechnologies Inc., of Montreal, reported preliminary Phase II results from a study of ThGRF, showing positive effects on body composition, such as increased muscle and decreased fat in patients suffering from chronic wasting, or muscle depletion, secondary to chronic obstructive pulmonary disease. Use of the growth hormone-releasing factor analogue also produced a series of other positive findings in functional measures and a good safety profile. The company said the results support further late-stage development of ThGRF in chronic obstructive pulmonary disease wasting. Two other Phase II studies remain under way. The first, which is measuring the product's efficacy in the recovery of wasting patients following hip fracture surgery, is expected to produce results in December. The second, which is measuring ThGRF's lipolytic effect in HIV-related lipodystrophy, is expected to produce results in the first quarter of next year.

• TolerRx Inc., of Cambridge, Mass., set the price range for its initial public offering at $12 to $14 and its number of shares at 4.7 million. The company, which is focused on immune system diseases, filed for its IPO nearly two months ago, seeking $75 million. (See BioWorld Today, Aug. 28, 2003.)

• Vion Pharmaceuticals Inc., of New Haven, Conn., entered a license agreement with Beijing Pason Pharmaceuticals Inc. in China for the exclusive rights to develop, manufacture and market Triapine for cancer and antiviral uses in China, Taiwan, Hong Kong and Macao. The agreement needs final approval from various Chinese government agencies. Terms of the agreement include an initial payment of $500,000 to Vion upon receipt of required approvals, $4.75 million in potential milestone payments, and royalty payments of 11 percent on Triapine revenues. Pason will fund the preclinical and clinical development. Vion's stock (NASDAQ:VION) rose 65 cents, or 40.6 percent, to close at $2.25.

• Vyrex Corp., of La Jolla, Calif., decided not to extend its collaboration with The Immune Response Corp., also of La Jolla, to develop Vyrex's water-soluble prodrug of propofol. The agreement dated back more than five years. The company said it is seeking a new partner to further develop and eventually commercialize the compound. Another Vyrex partnership ended following the expiration of its Materials-Cooperative Research and Development Agreement with the National Institute of Neurological Disorders and Stroke, a unit of the National Institutes of Health in Bethesda, Md. The company had provided Panavir to the institute for a study to determine if the compound would aid in the prevention of delayed cerebral vasospasm in a primate model of subarachnoid hemorrhage, but the results were inconclusive. (See BioWorld Today, March 10, 1997.)

• Xenova Group plc, of Slough, England, said preclinical studies of its OX40 platform technology conducted by Imperial College in London showed that down-regulation of the immune response by blocking the OX40-OX40 ligand interaction alleviates the symptoms of influenza without affecting the ability to clear the virus. The research suggests that the down-regulation could play a role in the fight against the symptoms of influenza and other diseases characterized by excessive immune response.

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