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Clinic Roundup

BIOWORLD Today - Sep. 21, 2008

Althea Technologies Inc., of San Diego, secured a $12 million line of credit from City National Bank. The funding will buy equipment for the company's recently built cGMP manufacturing plant, which is slated to begin contract manufacturing in the fourth quarter.

Ambrilia Biopharma Inc., of Montreal, said it successfully manufactured a final one-month formulation of goserelin, a luteinizing hormone-releasing analogue, intended for the treatment of prostate cancer and several gynecological indications. The company already developed a three-month formulation of goserelin, which is in Phase I/II testing in prostate cancer.

Cequent Pharmaceuticals Inc., of Cambridge, Mass., said it met its second milestone in its option agreement with the Novartis Option Fund and will move on to the next phase to validate targets for inflammatory bowel disease using Cequent's TransKingdom RNA interference technology in animal models. Specific payment terms and targets were not disclosed.

Cerus Corp., of Concord, Mass., said that the German Red Cross in the Baden-Wurttemberg-Hessen region (DRK Frankfurt) has agreed to collaborate in the development of the company's Intercept Blood System for red blood cells. Terms of the agreement call for the DRK Frankfurt to invest both expertise and personnel to support commercial system design and validation, and activities directed toward German regulatory approval. In exchange, DRK Frankfurt will receive royalties on potential sales in Europe. The collaboration gives Cerus direct access to DRK Frankfurt's scientific and operational expertise. DRK Frankfurt will support the development of the commercial product and design of a system compatible with blood processing procedures in Europe. Under the agreement, the two organizations will work to plan Phase III and Phase IV trials of the red blood cell system in Europe.

Cleveland BioLabs Inc., of Buffalo, N.Y., said the Biomedical Advanced Research and Development Authority of the Department of Health and Human Services awarded the company a contract for selected tasks in the advanced development of Protectan CBLB502. The total contract value, including all milestone-based options, is $13.3 million over a three-year period, with the first year's award totaling $3.4 million. Protectan CBLB502 is being developed under the FDA's animal efficacy rule to treat radiation injury following exposure to radiation from nuclear or radiological weapons or from nuclear accident.

Compugen Ltd., of Tel Aviv, Israel, said that recently analyzed in vitro and initial in vivo results from cell-based assays and a lung cancer mouse model indicated that CGEN-25008 reduced the growth rate of several cancer cell lines and significantly enhanced the anticancer activity of paclitaxel. CGEN-25008, a peptide antagonist of the Clusterin protein discovered by Compugen using its DAC Blockers Discovery Platform, has been shown to slow the growth of human non-small-cell lung cancer cells and other malignant cell lines, including breast, prostate, colon and melanoma cancers when tested directly on such cancer cells.

DSM Pharmaceutical Products, of Parsippany, N.J., and LibraGen, of Toulouse, France, said they have signed an agreement to co-develop new omega-transaminases for production of chiral amines. Under the partnership, LibraGen will use its proprietary enzyme discovery and development to identify new enzymes for efficient conversion of a large spectrum of ketons into optically pure R- and S-amines, a compound class highly relevant for fine chemicals and pharmaceuticals industries.
DSM will produce the enzymes at industrial scale using its fermentation capabilities and proprietary expression platform, PluGbug. LibraGen will sell the enzymes in kit form, and both parties will use them for screening activities and the development of biocatalytic processes for third parties.

Elite Pharmaceuticals Inc., of Northvale, N.J., raised $1.7 million through the private placement of 1,727 shares of Series D preferred stock priced at $1,000 per share, each convertible at 20 cents into 5,000 shares of common stock. The purchasers also received five-year warrants to buy an aggregate of 17.2 million shares at an exercise price of 25 cents per share. Shares of drug delivery firm Elite (AMEX:ELI) fell 4 cents, or 26.7 percent, to close at 11 cents on Tuesday.

EPIX Pharmaceuticals Inc., of Lexington, Mass., said it achieved another milestone in its collaboration with Cystic Fibrosis Foundation Therapeutics Inc. (CFFT), the nonprofit affiliate of the Cystic Fibrosis Foundation. EPIX will receive $500,000, bringing the total amount of milestone payments received under the collaboration to date to $4.5 million. EPIX and CFFT are collaborating to discover potential drug candidates targeting the cystic fibrosis transmembrane conductance regulator ion channel, and EPIX will own all worldwide rights to any compound resulting from the partnership. In April, the potential value of the collaboration was expanded to more than $50 million.

Horizon Discovery Ltd., of Cambridge, UK., said that it has signed a commercial agreement with Millennium Pharmaceuticals Inc., of Cambridge, Mass., to broadly evaluate its X-MAN technology. Millennium will pay Horizon a six-figure fee and share key datasets. The X-MAN "Mutant And Normal" human isogenic cell-lines are the first genetically defined in vitro models of human cancer and their matched normal cell types, that help accelerate and rationalize the discovery of personalized medicines and their assessment in clinical trials. The agreement covers an eight-month evaluation of a panel of seven cell lines. Millennium will further characterize the lines and test known targeted agents against those genotypes as well as internally developed compounds.

InNexus Biotechnology Inc., of British Columbia, said results of an extensive mouse tumor study demonstrated superiority of its DXL625 (CD20) vs. Rituxan (rituximab) in the xenograft model. The company plans to submit the data for publication and present it at the American Association for Cancer Research meeting next year. The company also launched a large-scale study of DXL625 with primates, designed to evaluate toxicity and pharmokinetics, enabling the company to move the product to the FDA toward human testing.

Invitrogen Corp., of Carlsbad, Calif., signed an exclusive U.S. distribution agreement with Biocare Medical LLC, of Concord, Calif., for the new SPOT-Light HER2 CISH Kit. The kit received FDA premarket approval in July as an aid in assessing breast cancer patients for whom trastuzumab (Herceptin) treatment is being considered. About a million people worldwide are screened each year for HER2 amplification or overexpression. As required by the FDA, laboratories must be certified prior to purchasing the kit for use on patient specimens.

Isogenica Ltd., of Cambridge, UK, entered into an agreement with Pfizer Inc., of New York, in which Isogenica's CIS display technology will be evaluated by Pfizer for its ability to generate therapeutic peptide candidates. Financial terms were not disclosed.

Micromet Inc., of Bethesda, Md., said it appointed Peter Johann as a member of the firm's audit committee, which fills a vacancy left by the resignation of Barclay Phillips, who voluntarily resigned as an independent director to join the company as its chief financial officer starting Aug. 30. The company said that Johann's appointment closes a compliance matter with Nasdaq.

MIP Technologies AB, of Lund, Sweden, received approximately $382,000 from the Swedish Research Council for a collaborative research effort with Lund University aimed at production of polymer materials that mimic biological macromolecules such as proteins, enzymes and antibodies.

Mymetics Corp., of Nyon, Switzerland, said preliminary SHIV challenge results showed that the firm's mucosal HIV-AIDS vaccine significantly exceeded the industry standard of 60 percent to 70 percent effectiveness to be considered as a promising vaccine. The company said it plans to conduct further tests, and will present fully detailed results and the challenge protocols at the Keystone Symposia in Colorado in March 2009. In addition, the firm said it expects to initiate a Phase I trial in November.

OccuLogix Inc., of Toronto, said it was notified that the Nasdaq Listing and Hearing Review Listing Council has called for a review of the Sept. 8 decision of the Nasdaq Listing Qualifications Panel pursuant to which the company's securities were to be delisted, effective at the open of business Sept. 18. As a result, the company's securities will continue to trade on the Nasdaq Capital Market pending further consideration of the matter, and the listing council gave OccuLogix until noon Oct. 24, to submit any additional information.

Oramed Pharmaceuticals Inc., of Jerusalem, initiated preclinical studies of its oral GLP1 analogue ORMD 0901 for diabetes. The company recently completed a Phase IIa trial of oral insulin capsule ORMD 0801 and plans to begin a Phase IIb trial in India by the first quarter of 2009.

Perlegen Sciences Inc., of Mountain View, Calif., said that it launched a new approach to discovering rare genetic variations. The company is employing this approach in a study of women who have received hormone replacement therapy, to survey a large proportion of the expressed genome for the presence of rare genetic variants that alter women's risk of developing breast cancer. The new approach will enable Perlegen to efficiently identify more of the genetic basis behind the differences in patients' disease risks and response to drugs.

Pharmacopeia Inc., of Princeton, N.J., said it has identified a new lead for advancement in its alliance with GlaxoSmithKline plc, of London, through its collaboration with the Center of Excellence for External Drug Discovery. The newly identified lead compound is from a program being evaluated as a potential treatment for inflammatory pain and is the sixth lead compound identified through the collaboration. As a result of that success, Pharmacopeia received a $500,000 milestone payment from GSK. Pharmacopeia has received a total of $18 million from GSK in connection with the alliance.

Pluristem Therapeutics Inc., of New York, said it concluded its preclinical efficacy studies of PLX-PAD, a cellular product for critical limb ischemia, which showed that animals receiving intramuscular injections of the drug after their hind legs had been rendered ischemic had statistically significant increase in blood flow, angiogenesis and functionality at 30 days post-injection. Pluristem intends to file for approval to begin clinical testing.

Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., entered an agreement to provide researchers at Columbia University Medical Center with access to the company's VelocImmune technology to discover fully human monoclonal antibodies. Under the agreement, Columbia scientists will use VelocImmune mice to generate antibodies against their research targets and will conduct research to discover potential human therapeutics based on those antibodies. Regeneron has an exclusive option to license the antibodies for development and commercialization for therapeutic or diagnostic purposes.

Repligen Corp., of Waltham, Mass., said preclinical results demonstrated that its histone deacetylase inhibitor improved disease symptoms in a transgenic animal model of Huntington's disease. The study showed that oral administration of the drug candidate to mice after the onset of symptoms slowed the progression of the disease, and treated animals showed superior motor performance by multiple measures, including reduced loss of body weight, reduced brain atrophy and improved overall appearance vs. untreated animals. Results of that study will be published this week in the Proceedings of the National Academy of Sciences.

Sequenom Inc., of San Diego, said it acquired exclusive worldwide rights (excluding Hong Kong) to digital PCR and other noninvasive prenatal diagnostic intellectual property from the Chinese University of Hong Kong. Those rights expand Sequenom's existing IP portfolio of prenatal diagnostic methods using fetal nucleic acids obtained from a maternal sample. Financial terms were not disclosed.

Sirtris, of Cambridge, Mass., a subsidiary of GlaxoSmithKline plc, said it completed an agreement with Harvard University to license exclusively two patent applications covering SIRT3-based methods of treatments and assays useful in identifying SIRT3 activators for diseases of aging. Financial terms were not disclosed.

Transgenomic Inc., of Omaha, Neb., said it partnered with Key Genomics, of Charlottesville, Va., to develop a molecular diagnostic test to guide clinicians in their choice of currently available treatments for ovarian cancer. The test will be powered by Key Genomics' predictive algorithm COXEN (Co-eXpression ExtrapolatioN). Financial terms were not disclosed.

ViRexx Medical Corp., of Edmonton, Alberta, indefinitely laid off all employees except its chairman, Darrell Elliott. The company was unable to secure financing after a recent funding agreement with LM Funds Corp. fell through. Elliott will oversee restructuring of the company's assets, which include antiviral and cancer programs.

XOMA Ltd., of Berkeley, Calif., said it initiated new therapeutic antibody programs under an existing discovery and development collaboration with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan. The new programs add to the multiple discovery and development programs already being advanced through the collaboration. Since 2006, Takeda and XOMA have worked together on antibody development. (See BioWorld Today, Nov. 3, 2006.)

ZenBio Inc., of Research Triangle Park, N.C., has been awarded a $200,000 Phase I SBIR grant to provide a human primary cell system for breast cancer research. The award from the National Institutes of Health will fund the isolation and culturing of primary human basal and luminal mammary ductal cells for the development of a donor-matched cell system.

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BIOWORLD Today - Sep. 21, 2008

Axial Biotech Inc., of Salt Lake City, said it identified specific genetic markers for scoliosis, and the research made it possible to develop a DNA-based prognostic test for spinal curve progression in patients with adolescent idiopathic scoliosis. The research involved collecting DNA samples from more than 9,000 patients from 85 clinical sites. All patient samples were analyzed on several technology platforms, and specific disease classifications were evaluated by the review of X-rays and medical records provided from physicians who were treating patients enrolled in the study. The test will be marketed under the trade name of ScoliScore.

Cell Genesys Inc., of South San Francisco, said the FDA has placed a partial clinical hold on the GVAX Phase III program for prostate cancer as a result of the company's announcement to terminate the VITAL-2 trial for the product. The trial's independent data monitoring committee recommended the action after a safety review showed an imbalance in deaths between the treatment and control arms of the study. The FDA has confirmed that patients receiving maintenance doses of GVAX immunotherapy for prostate cancer in the trial, which completed enrollment with 626 patients in 2007, can continue to receive treatment after appropriate patient notification. The FDA also agreed that patients enrolled in the recently terminated VITAL-2 trial may continue to receive Taxotere (docetaxel) in the control arm, and as per investigator discretion in the investigational arm in place of combination therapy with GVAX immunotherapy plus Taxotere. A specific cause for the imbalance in deaths has not been identified. The company is preparing to analyze the clinical data to potentially determine the cause for the higher number of deaths observed in the GVAX-plus-Taxotere combination arm, including an assessment of potential imbalances between the two arms of the study such as baseline characteristics and prognostic factors, as well as other treatment variables. (See BioWorld Today, Aug. 28, 2008.)

Genentech Inc., of South San Francisco, and Biogen Idec Inc., of Cambridge, Mass., informed health care providers Thursday about a death from progressive multifocal leukoencephalopathy (PML) in a patient with rheumatoid arthritis who received Rituxan (rituximab) in a long-term safety extension clinical study. The firms said the death is the first reported case of PML in a Rituxan-treated patient with rheumatoid arthritis. The patient developed an infection from a John Cunningham virus, a type of human polyomavirus, which resulted in PML. The patient died 18 months after taking the last dosage of Rituxan. Genentech and Biogen said the case of PML was confounded because the patient had developed oropharyngeal cancer and was treated with chemotherapy and radiation nine months before developing PML. The patient also had a complex medical and rheumatologic history and had been treated with various immunosuppressants. The companies urged health care professionals treating patients with Rituxan to consider PML in anyone presenting with new onset neurologic manifestations and to consult a neurologist and consider conducting a brain MRI and lumbar puncture on the patient. Rituxan's labeling already had noted reports of PML in patients with hematologic malignancies and autoimmune diseases, conditions for which Rituxan is not approved. The firms updated the labeling to reflect the death from PML in the patient with rheumatoid arthritis.

Haemacure Corp., of Montreal, disclosed positive results of a second preclinical study on the use of its lead product candidate, the human fibrin sealant Hemaseel HMN, in preventing the formation of postsurgical adhesions in a bleeding surgical model. Use of Haemacure's fibrin sealant in the presence of blood resulted in a statistically significant reduction in the incidence, extent and severity of adhesions, as compared to the untreated control group. Haemacure's fibrin sealant also was statistically more effective than both Interceed and Seprafilm, the company said.

ImClone Systems Inc., of Cambridge, Mass., and Bristol-Myers Squibb Co., of New York, said results from the Phase III EXTREME trial of Erbitux (cetuximab) plus platinum-based chemotherapy in the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck were published in the New England Journal of Medicine. Results of the study, conducted by Merck KGaA, of Darmstadt, Germany, showed that adding Erbitux to a platinum-based chemotherapy in the first-line treatment of SCCHN resulted in statistically significant improvement in the primary endpoint of overall survival, as well as secondary endpoints of progression-free survival and overall response rate.

MedImmune, of Gaithersburg, Md., the biologics unit of AstraZeneca plc,, and SBI Biotech Co. Ltd., a subsidiary of SBI Holdings Inc., of Tokyo, have entered into a licensing and collaboration agreement to develop and commercialize SBI Biotech's anti-ILT7 protein for the potential treatment of systemic lupus erythematosus (SLE) and other autoimmune diseases. MedImmune has global rights to any resulting product candidates and will be responsible for preclinical and clinical development, as well as all future development, manufacturing, sales and marketing activities. Under the terms of the agreement, MedImmune will provide SBI Biotech with an undisclosed up-front payment, milestone payments and royalties on future marketed products. SBI Biotech has granted MedImmune an exclusive license to research, develop and commercialize products that target the ILT7 protein. In addition, MedImmune will have the option to license additional targets resulting from SBI Biotech's research activities. Financial terms were not disclosed. ILT7 is a cell surface protein expressed on plasmacytoid dendritic cells, which are believed to be critical in the development of autoimmune diseases such as systemic lupus erythematosus.

Merck KGaA, of Darmstadt, Germany, said its Merck Serono division has submitted an application to the European Medicines Agency to license Erbitux (cetuximab) for the first-line treatment of epidermal growth factor receptor (EGFR) expressing, advanced or metastatic non-small-cell lung cancer (NSCLC). The submission is supported by data from the Phase III FLEXa study, which demonstrated a significant increase in overall survival for patients receiving Erbitux in combination with a platinum-based chemotherapy as a first-line treatment for advanced NSCLC.

Myriad Genetics Inc., of Salt Lake City, said its board is reviewing management's analysis of several strategic alternatives including whether to spin off the pharmaceutical subsidiary from Myriad's molecular diagnostic business in a transaction that would result in two independent and highly focused businesses. The company hired investment banking firm JP Morgan to review strategic alternatives after a failed Phase III trial of Flurizan in Alzheimer's disease. (See BioWorld Today, Aug. 21, 2008.)

The National Cancer Institute announced 18 new Small Business Innovation Research contract funding opportunities for fiscal year 2009 intended to aid small businesses on the brink of taking their innovative cancer research to the next level but in need of early stage technology financing. The NCI SBIR program solicits proposals for contracts once annually. The current NCI solicitation is supporting R&D related to anticancer agents, cancer biomarkers, proteomics, diagnostics and other areas of interest to the agency. A complete listing and other information is posted on the program's website at sbir.cancer.gov. The deadline for receipt of contract proposals is Nov. 3.

Novacea Inc., of South San Francisco, said the FDA has released the clinical hold on the Asentar investigational new drug application that was imposed in November 2007 after the ASCENT-2 Phase III trial showed an imbalance of deaths between the treatment and control arms of the trial. The study was comparing Novacea's Asentar (DN-101) plus the chemotherapy agent Taxotere (docetaxel) with Taxotere alone in patients with androgen-independent prostate cancer. The FDA also required that any future studies conducted with Asentar include in the consent form an unambiguous statement that the ASCENT-2 trial showed reduced survival for patients and any future consent form must not make reference to any survival benefits observed in earlier clinical trials involving Asentar for the treatment of AIPC patients. Despite the FDA action, the company said it has no plans for further development of Asentar. (See BioWorld Today, Nov. 6, 2008.)

Trubion Pharmaceuticals Inc., of Seattle, said the Opposition Division of the European Patent Office has revoked European Patent 1176981, in its entirety, which had been granted to Genentech Inc., of South San Francisco, and Biogen Idec Inc., of Cambridge, Mass. The patent was generally directed to the use of an anti-CD20 antibody for the treatment of rheumatoid arthritis. The revocation was the result of an opposition proceeding brought by Trubion and several other parties. The OD, in oral proceedings, ruled that the patent as granted did not meet the requirements for patentability under the European Patent Convention. Genentech and Biogen Idec have the right to appeal the decision. Shares of Trubuion (NASDAQ:TRBN) rose 10 cents Thursday, to close at $3.65.

Vaxin Inc., of Birmingham, Ala., said it has been awarded a $955,357 Small Business Innovation Research grant from the National Institutes of Health to support the ongoing development of the firm's novel avian influenza vaccine. Vaxin is pursuing two development paths, the first being a needle-free, single-dose vaccine to protect humans in the general population, and the second a method to quickly and easily mass-vaccinate domesticated poultry for preventing the spread of the disease.

Viral Genetics Inc., of Azusa, Calif., completed an initial study of Lyme disease, which it said also could offer answers to other immune-based diseases including HIV/AIDS. The company said its model described a potentially novel mechanism in which bacterial infection with the pathogen Borrelia burgdorferi activates the immune system. The new model suggested that the nature of the immune response may be responsible for the pathology of the disease and that targeted peptide therapy has the potential to resolve disease symptoms.

ViRexx Medical Corp., of Edmonton, Alberta, claimed in a statement that LM Funds Corp., the standby guarantor under a previously announced rights offering, has failed to fulfill its obligation to provide C$3 million (US$2.79 million) as agreed to. In June, ViRexx announced the funding agreement, but Thursday said LM Funds notified the company that it will not meet the obligation. ViRexx said 14 million shares were tendered as a result of the agreement. Those shareholders will have a right to rescind their offers.

XOMA Ltd., of Berkeley, Calif., and the Texas A&M University System have entered into an agreement to explore options for the development and manufacture of antibodies and protein-based therapeutics for human and veterinary applications. The organizations said they plan to discuss the design and establishment of a state-of-the-art GMP manufacturing facility in Texas to spur academic research in diverse biological and bioengineering disciplines, and create a world-class biological manufacturing capacity within the state.