• Aeolus Pharmaceuticals Inc., of San Diego, reported positive results from its completed Phase I single-dose study of AEOL 10150, a small-molecule catalytic antioxidant that can scavenge free radicals, thereby amplifying the body's natural enzymatic systems for eliminating those compounds, in patients with Lou Gehrig's disease. All six single doses of varying strengths were well tolerated with no serious adverse effects or significant laboratory abnormalities, the company said. A Phase I multidose study is expected to start before year-end.

• AnorMed Inc., of Vancouver, British Columbia, said a study published in the recent issue of Blood demonstrates that cancer patients who received AMD3100 (Mozobil) plus granulocyte-colony stimulating factor (G-CSF) were able to collect more stem cells in less time compared to the standard mobilization regimen, G-CSF alone. All patients receiving combination treatment collected enough cells for transplant, compared to 64 percent of patients using G-CSF alone. Mozobil is the first in a class of agents designed to induce rapid mobilization of stem cells from the bone marrow into the peripheral blood system.

• Antares Pharma Inc., of Exton, Pa., initiated a Phase II trial of its oxybutynin-based Anturol (AP-1034) for the treatment of overactive bladder syndrome. The trial, an open-label, randomized dose-ranging study, is being conducted in Germany. It will enroll 48 volunteers and will involve the testing of three doses over 20 days. The completion of the trial is expected before the end of December.

• Avalon Pharmaceuticals Inc., of Germantown, Md., said that on Sept. 1, it submitted an investigational new drug application to the FDA for its lead candidate, AVN944, for cancer. Subject to FDA acceptance, the company plans to begin its first U.S. Phase I trial of AVN944 in patients with hematologic malignancies. AVN944 is an inhibitor of the enzyme inosine monophosphate dehydrogenase, which is essential for de novo synthesis of the nucleotide guanosine trisphosphate, the company said.

• AVAX Technologies Inc., of Philadelphia, filed an investigational new drug application for a Phase I/II trial of its AC Vaccine as a first-line treatment after surgery in patients with Stage I and Stage II non-small-cell lung cancer. The study endpoints include safety and a measure of cellular immunity - described as delayed-type hypersensitivity to the patient's own lung cancer cells.

• BioSyntech Inc., of Laval, Quebec, closed its private placement of 7.5 million shares at a price of 80 cents per share by Nicholas Piramal India Ltd., of Mumbai, India. The $6 million financing is expected to provide funds for the company to reach its 2006 clinical milestones for BST-CarGel, BST-DermOn and BST-InPod. As part of the arrangement, NPIL acquired exclusive rights for marketing BioSyntech's products in India and surrounding areas, and gained the right to appoint its chief scientific officer, Somesh Sharma, to BioSyntech's board.

• BioVeris Corp., of Gaithersburg, Md., entered an agreement with The Rockefeller University in which the company receives an exclusive, worldwide license on patents and know-how to manufacture, use and commercialize a vaccine candidate for Group A streptococcal disease. BioVeris paid an initial $150,000 license issue fee and may make additional payments for license maintenance and patent costs, as well as for milestone achievements and royalties.

• Celera Diagnostics Inc., of Alameda, Calif., extended its collaboration with Merck & Co. Inc., of Whitehouse Station, N.J., to include treatments for Alzheimer's disease. The companies will combine their research on a series of genes targeted for drug development. Under the only disclosed term of the agreement, Celera will genotype selected gene-based mutations in four independent case-control sample collections.

• Celldex Therapeutics Inc., of Bloomsbury, N.J., withdrew its initial public offering filed in April 2004. The company registered for an estimated $50 million offering, but later set a price range to sell 4 million shares between $8 and $10 apiece. Celldex, a wholly owned subsidiary of Princeton, N.J.-based Medarex Inc., has a lead cancer vaccine, HCG-VAC, in development to treat colorectal, pancreatic, bladder and breast cancers.

• CytRx Corp., of Los Angeles, said interim results from a Phase I trial indicates that its HIV DNA + protein vaccine was well tolerated, and that it stimulated immune T cells that could attack AIDS virus-infected cells. The drug also produced antibody responses with neutralizing activity against multiple HIV viral strains. Those data were presented at the AIDS Vaccine 2005 International Conference in Montreal.

• Eidogen-Sertanty Inc., of San Diego, has licensed its Kinase Knowledgebase to Medisyn Technologies, of Minnetonka, Minn. The Kinase Knowledgebase is Eidogen-Sertanty's database of structure-activity relationships and chemical synthesis data focused on protein kinases. Also Eidogen-Sertanty launched a small-molecule library focused on inhibitors of several protein kinase families. The Kinase-Targeted Library was completed as part of a collaboration with Specs, a supplier of screening compounds and research chemicals.

• Elite Pharmaceuticals Inc., of Northvale, N.J., completed a $4.2 million bond financing through the New Jersey Economic Development Authority, with the proceeds to be used to redeem previously issued tax-exempt bonds issued by the authority in September 1999. Money also will go toward refinancing other former equipment financing, as well as to provide about $1 million of capital for the purchase of additional equipment for product manufacturing and development.

• Flamel Technologies SA, of Lyon, France, was informed that TAP Pharmaceutical Products Inc., of Lake Forest, Ill., terminated its license for the use of Flamel's Micropump technology to deliver lansoprazole, the active ingredient in TAP's Prevacid. TAP instead will begin Phase III studies on an enantiomer of lansoprazole. The termination will take effect in December.

• Genentech Inc., of South San Francisco, said it plans to file a biologics license application for Lucentis (ranibizumab) as a treatment for wet age-related macular degeneration in December of this year. Though the company did not receive fast-track designation for the drug, which would have allowed a rolling BLA submission, Genentech said it expects no delay in regulatory filing, and the application still has the potential to obtain priority review by the FDA. In the meantime, the company is in discussions with the agency regarding plans to begin a Phase IIIb trial of Lucentis before the end of the year.

• Gentium SpA, of Villa Guardia, Italy, will start a Phase III trial for Defibrotide for the treatment of hepatic veno-occlusive disease, a life-threatening condition in which some of the veins in the liver are blocked as a result of toxic cancer treatments. Representatives of the company met with FDA officials, and the FDA encouraged Gentium to conduct further studies of the treatment. Defibrotide has been granted orphan drug status for the treatment of severe hepatic veno-occlusive disease and fast tracked for treatment of recipients of stem cell transplants.

• GenVec Inc., of Gaithersburg, Md., said preliminary safety and immune response data from an ongoing Phase I trial involving an HIV vaccine candidate developed by GenVec and the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases showed that the vaccine regimen combining DNA priming and adenovector boosting was well tolerated and produced a vigorous cellular and antibody immune response. Those findings were presented at the AIDS Vaccine 2005 International Conference in Montreal.

• GTx Inc., of Memphis, Tenn., said Phase I data for ostarine, its second selective androgen receptor modulator, were consistent with anabolic activity without evidence of unwanted androgenic side effects on prostate and skin sebaceous glands. GTx intends to begin a Phase II trial of ostarine to treat muscle wasting associated with burns during the fourth quarter.

• Hana Biosciences Inc., of South San Francisco, initiated a Phase I IPdR trial in colorectal, gastric, pancreatic and liver cancers. The objectives of the trial are to establish the safety, dose and preliminary efficacy of IPdR in combination with radiation therapy. IPdR is an orally available, thymidine analogue and prodrug for IUdR, which demonstrated a survival advantage in Phase II studies in anaplastic astrocytoma, a type of brain tumor.

• IDM Pharma Inc., of San Diego, announced final Phase I results of its EP HIV-1090 DNA vaccine in 40 HIV-1 infected individuals with full suppression of HIV-1 replication on stable anti-retroviral therapy. Results were presented at the AIDS Vaccine 2005 International Conference in Montreal.

• Immunetrics Inc., of Pittsburgh, entered an agreement under which it will collaborate with Eli Lilly and Co., of Indianapolis, in the application of in silico modeling technology to clinical trial design. The specific application, which was not disclosed, involves the adaptation of existing Immunetrics models of inflammation for the identification of biomarkers and the development of design parameters for relevant human studies.

• ImmunoGen Inc., of Cambridge, Mass., initiated a Phase I study with its Tumor-Activated Prodrug compound, huN901-DM1, in multiple myeloma. The compound also is in two clinical trials for the treatment of small-cell lung cancer.

• Inhibitex Inc., of Atlanta, said the independent Data Safety Monitoring Board responsible for reviewing the Phase III trial of Veronate determined that the trial should proceed as designed. The company also reported that, as of Sept. 2, it had enrolled more than 1,700 of the 2,000 very-low-birth-weight infants it intends to enroll. The final DSMB review is expected in November, when the trial is fully enrolled. Veronate is an antibody-based drug in development to prevent hospital-associated infections in premature infants with low birth weights.

• Inspire Pharmaceuticals Inc., of Durham, N.C., said the SEC is conducting a formal, nonpublic investigation, which the company believes relates to trading in its securities surrounding the results released Feb. 9, 2005, of the Phase III trial of diquafosol tetrasodium to treat dry eye, as well as the company's disclosures regarding the Phase III trial. The company said it and one of its directors received a subpoena in connection with the investigation.

• Introgen Therapeutics Inc., of Austin, Texas, and its collaborators at the University of Texas M.D. Anderson Cancer Center presented data describing the critical role that MDA-7/IL-24 plays in controlling the growth of melanoma cells and inducing melanoma cells to undergo apoptosis. MDA-7/IL-24 is the active ingredient of INGN 241, Introgen's investigational cancer therapy in Phase II studies to treat metastatic melanoma. Those data were presented at the 6th World Congress on Melanoma in Vancouver, British Columbia. The company presented similar data on INGN 241 at the 8th International Conference on Emerging Technologies in Drug and Gene-Based Therapeutics in Crete, Greece.

• ISTA Pharmaceuticals Inc., of Irvine, Calif., said the American Journal of Ophthalmology published the pooled safety and efficacy findings of the company's two randomized, double-masked, placebo-controlled Phase III studies of Vitrase for the management of vitreous hemorrhage. The analysis showed a statistically significant reduction in vitreous hemorrhage density as early as one month that persisted through three months following a single intravitreous injection of Vitrase compared to a single injection of saline solution.

• Knopp NeuroSciences Inc., of Pittsburgh, secured an exclusive license from the University of Pittsburgh to commercialize a panel of protein biomarkers as a diagnostic test for amyotrophic lateral sclerosis. The markers were discovered using SELDI-based mass spectrometry.

• Labopharm Inc., of Laval, Quebec, received regulatory approval for its once-daily tramadol product for 22 countries under the mutual recognition procedure, and reached agreements with those countries on a common product label. Tramadol is indicated to treat moderate to severe pain, including both acute and chronic conditions. Countries covered by the approval include Germany, the UK, Italy, Spain, Portugal, Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Iceland, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Slovak Republic, Slovenia and Sweden. Labopharm expects to receive approval from the individual countries starting within the next 30 days.

• Liponex Inc., of Ottawa, Ontario, said the new formulation of its lead drug candidate, CRD5, demonstrated a significant increase in bioavailability and efficacy in animal models. The company plans to begin a Phase II study of CRD5, which is designed to treat and prevent heart disease by increasing the level of HDL in the blood and controlling the actions of HDL in the body.

• Lorus Therapeutics Inc., of Toronto, will collaborate with Guido Marcucci, a leukemia researcher at the Ohio State University Comprehensive Cancer Center, on laboratory experiments on acute myeloid leukemia cell lines. The experiments are designed to provide insight into the correlation between antitumor response and the cellular effects of GTI-2040 - an antisense drug that targets the R2 component of ribonucleotide reductase required for DNA synthesis and cell proliferation - and cytarabine when given together.

• Manhattan Pharmaceuticals Inc., of New York, said Oleoyl-estrone (OE), its obesity drug, was shown to be safe, with no serious adverse events, in a Phase Ia study of 36 obese volunteers. Those results were presented at the Oppenheimer & Co. Diabetes Conference in New York. A follow-on Phase Ib study will assess the drug's safety and tolerability in 24 volunteers divided into four cohorts, with each receiving either placebo or OE in doses ranging from 10 mg to 150 mg for seven consecutive days. Results from that trial are expected in early fall.

• MannKind Corp., of Valencia, Calif., filed a registration statement with the SEC to cover the resale by certain stockholders of its 17.1 million shares of common stock issued in a private placement completed Aug. 5 and 3.4 million shares of stock issuable upon exercise of warrants also sold in the private placement. The company raised $175 million through the private stock sale, with its top executive buying into half of the placement, to fund late-stage development of its Technosphere Insulin System. (See BioWorld Today, Aug. 4, 2005.)

• MediciNova Inc., of San Diego, completed patient enrollment in a Phase II study with MN-001 in asthma. MN-001, which is orally administered, is a leukotriene receptor antagonist and an inhibitor of phosphodiesterases III and IV, 5-lipoxygenase, as well as thromboxane A2. MediciNova licensed MN-001 from Kyorin Pharmaceutical Co. Inc., of Tokyo, with exclusive worldwide rights, except for Japan, China, Taiwan and South Korea.

• Nuevolution A/S, of Copenhagen, Denmark, said Knud Aunstrup is stepping down as CEO, and he will be replaced by Alex Haahr Gouliaey. Nuevolution is a drug discovery firm that uses its Chemetics technology to generate small-molecule drug leads.

• Nuvelo Inc., of Sunnyvale, Calif., enrolled the first patient in a Phase III study of alfimeprase for the treatment of central venous catheter occlusion. The SONOMA-2 (Speedy Opening of Non-Functional and Colluded Catheters with Mini-Dose Alfimeprase) trial will compare the efficacy of 3 mg of alfimeprase with placebo in 300 patients with occluded central venous catheters. The primary endpoint is restoration of the catheter within 15 minutes. Earlier this year, Nuvelo initiated a Phase III study of alfimeprase, an enzyme produced by recombinant DNA technology to degrade fibrin, in patients with acute peripheral arterial occlusion, also known as "leg attack." (See BioWorld Today, April 19, 2005.)

• OncoGenex Technologies, of Vancouver, British Columbia, said data from a completed Phase I study of OGX-011 shows the cancer drug was well tolerated and reduced clusterin expression in primary prostate cancers in humans. Primary and secondary objectives were achieved with statistical significance. The findings were published in a recent issue of the Journal of the National Cancer Institute.

• Oxxon Therapeutics Inc., of Boston, reported positive data from its ongoing Phase II immunotherapy study in patients with advanced melanoma. The study evaluated Oxxon's PrimeBoost platform and showed the technology's potential to produce an immune response. The study found 25 percent of the Stage III and IV patients were stable up to week 16, and 29 percent of the immunologically evaluable patients showed melanoma specific cellular immune responses.

• Panacos Pharmaceuticals Inc., of Watertown, Mass., filed a shelf registration statement to offer and sell up to $50 million of equity securities. The company intends to use the proceeds from any sale to fund its internal discovery and development programs, including its HIV therapeutic drug candidate PA-457, and other corporate purposes.

• Saneron CCEL Therapeutics Inc., of Tampa, Fla., and the University of Minnesota signed an exclusive license in which Saneron CCEL acquires worldwide rights to the university's cord blood cell line in exchange for research funding and milestone payments. Saneron CCEL will use the technology to expand its research on the development of cellular therapeutics for the treatment of neurological and cardiac disorders.

• Sangamo BioSciences Inc., of Richmond, Calif., agreed to provide Novo Nordisk A/S, of Bagsvaerd, Denmark, with access to its zinc finger DNA-binding protein (ZFP) technology to use in the field of enhanced protein production. ZFPs are the dominant class of naturally occurring transcription factors in organisms from yeast to humans.

• Solbec Pharmaceuticals Ltd., of Perth, Australia, said findings from its Phase I trail of Coramsine (SBP002) in the treatment of solid tumors showed that the primary endpoint of safety and tolerability was achieved, and that Coramsine was safe at a dose of 1 mg/kg/day infused over two hours, daily for five days, every two weeks. Reports also indicated that the drug met secondary endpoints by showing a potential therapeutic benefit in patients with advanced cancer.

• SpinX Technologies, of Geneva, secured €10 million (US$12.5 million) in a Series B financing to support its "programmable microfluidics" platform to perform biological assays. The round was led by Bio Fund Management, with participation from seed and Series A investors Index Ventures, Auriga Partners, DFJ ePlanet Ventures and the CERN Pension Fund. As part of the financing, Seppo Makinen, of Bio Fund Management, and Phillippe Peltier, of Auriga Partners, joined the company's board.

• Third Wave Technologies Inc., of Madison, Wis., said a federal jury found La Jolla, Calif-based Stratagene Corp. liable of willful patent infringement and awarded Third Wave $5.3 million in damages. Third Wave said it will seek additional damages. Meanwhile, Stratagene announced its intention to appeal the jury verdict. The case was heard in the U.S. District Court for the Western District of Wisconsin.

• TNO Pharma, of Leiden, the Netherlands, and Mitsubishi Pharma Corp., of Tokyo, entered a collaboration in which TNO will combine its expertise in siRNA-based, knock-down technology in disease models to further characterize a set of Mitsubishi's disease targets. Financial terms were not disclosed.

• Vernalis plc, of London, said patient enrollment for its confirmatory Phase III efficacy study of frovatriptan for intermittent, short-term prevention of menstrually related migraine has been completed. Top-line data from the trial, and the filing of a supplemental new drug application, are scheduled for the first half of 2006.

• Xigen SA, of Lausanne, Switzerland, closed its Series A round, raising CHF26 million (US$21 million). The financing was led by Geneva-based Tilocor Life Sciences, Toronto-based Venture Incubator and Initiative Capital. Funds will be used to advance Xigen's lead product, XG-102, into the clinic next year for the treatment of stroke. XG-102 is a neuroprotectant designed to act by intracellular inhibition of JNK kinase. The product was developed at the University Hospital of Lausanne, which spun out Xigen in 2002.

• XOMA Ltd., of Berkeley, Calif., granted Wyeth, of Madison, N.J., a nonexclusive, worldwide license for XOMA's expression technology. Wyeth receives a license to use XOMA's technology for the development and production of recombinant proteins. Financial details were not disclosed.