Biotech Values

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Clinic Roundup/ 3 roundups in one:

BioWorld Today - Sep. 18, 2008
http://www.therapeuticsdaily.com/news/article.cfm?contenttype=sentryarticle&contentvalue=1839311&channelID=31

Myriad Genetics Inc., of Salt Lake City, said it successfully completed dose escalation in the Phase I trial of Vivecon, its HIV viral maturation inhibitor, in healthy volunteers. The overall safety profile was favorable with no serious adverse events or clinically significant changes in laboratory values or ECG. The observed pharmacokinetic profile supported continued development. Vivecon has good oral bioavailability, and the study demonstrated enhanced absorption of Vivecon when taken with food. Based on those results, Myriad is proceeding to a Phase IIa study, a multiple-ascending dose trial in treatment-naïve HIV-infected individuals. The Phase IIa trial will further evaluate the safety, pharmacokinetic parameters and Vivecon's ability to inhibit viral replication.

Alfacell, of Somerset, N.J., said that its board of directors approved the engagement of Oppenheimer & Co. as a financial advisor in connection with the company's pursuit of available strategic alternatives, including a possible sale of the company. The alternatives will focus on, but not be limited to, strategic partnership transactions. No decision has been made to enter into any transaction at this time. Alfacell has completed Phase III trials of Onconase in unresectable malignant mesothelioma and, in addition to ongoing efforts to complete the related rolling new drug application, Alfacell is planning for Phase II trials in other oncology indications.

AtheroGenics Inc., of Atlanta, said in an 8-K filing that a petition for involuntary Chapter 7 bankruptcy was filed against the company by several investors. Earlier this month, the company defaulted on $30.5 million worth of convertible notes, choosing instead to use its cash for a confirmatory Phase III trial of AGI-1067 in diabetes. Shares of AtheroGenics (NASDAQ:AGIX) fell 8 cents, or 29.6 percent, to close at 19 cents on Wednesday. (See BioWorld Today, Sept. 3, 2008.)

China Biologic Products Inc., of Taian City, Shandong, China, said the company received approval from China's State Food and Drug Administration to begin clinical testing of its new human coagulation Factor VIII product, a coagulation treatment for hemophilia and mass hemorrhaging. Study results are expected by mid-2009. If the clinical study is successful, the company expects to get SFDA's approval for production to launch the product at the beginning of 2010.

Cyclacel Pharmaceuticals Inc., of Berkeley Heights, N.J., revised its operating plan that streamlines pipeline development and concentrates resources on the advancement of its lead drug, sapacitabine. The plan, effective immediately, reduces the work force across all locations by about 28 employees or 34 percent of total staff. Cyclacel will take an estimated $500,000 charge for severance payments in the quarter ending Sept. 30. Following the planned reductions in staff and operating expenditures, Cyclacel expects to lower annual operating costs by about $9 million. With the anticipated savings the company expects to have sufficient resources to fund operations for approximately 18 months. As of June 30, the company had $40 million in cash, cash equivalents and short-term investments.

Genitope Corp., of Fremont, Calif., said in an 8-K filing that it has suspended its MyVax cancer vaccine and antibody programs, it has $1 million remaining in net cash and marketable securities, CEO Dan Denney is its only remaining employee and no potential partners or acquirers have come forward. Accordingly, the company anticipates that it will seek protection under the federal bankruptcy laws or liquidate its assets and dissolve the corporation. Shares of Genitope (Pink Sheets:GTOP) fell 3 cents, or 68 percent, to close at 2 cents on Wednesday.

MannKind Corp., of Valencia, Calif., said Afresa is the new trade name for its Technosphere inhaled insulin product. MannKind expects to file an approval application for the drug later this year or in early 2009. The firm announced earlier this week that it is partnering with Pfizer Inc., of New York, to provide patients who were taking the now discontinued Exubera inhaled insulin with Technosphere under a compassionate use program. However, that program has yet to be approved by U.S. and European drug regulators. (See BioWorld Today, Sept. 17, 2008.)

Mesoblast Ltd., of Melbourne, Australia, said the FDA granted orphan drug designation for the use of its adult stem technology in patients undergoing bone marrow transplantation. The agency awarded Mesoblast's U.S.-based sister company, Angioblast Systems Inc., the right to use its "off-the-shelf" allogeneic mesenchymal precursor cells for insufficient hematopoietic stem cell production in patients with hematologic malignancies who have failed treatment with conventional therapy. Orphan status allows for an accelerated review process and guarantees seven years of marketing exclusivity upon approval.

Microchip Biotechnologies Inc., of Dublin, Calif., said it has been awarded a $625,000 contract under the U.S. Army's inaugural Commercialization Pilot Program (CPP) to develop a universal sample preparation module (USPM), which will automatically purify DNA from pathogen targets contained in complex matrices to provide samples for various downstream U.S. military sponsored analytical platforms. The CPP is a new program to assist firms that have Small Business Innovation Research Phase II projects that meet high-priority Army requirements in transitioning to commercial products. MBI's USPM, which is using the firm's Microscale On-chip Valves, will enable front-end sample preparation with high specificity for rapid detection, identification and diagnosis of biological threat agents and will be applicable to detecting pathogens for molecular diagnostics.

NitroMed Inc., of Lexington, Mass., said Nasdaq informed the firm that its stock price had closed below the minimum $1 per share requirement for 30 consecutive trading days. The company has until March 16 to come into compliance.

Omeros Corp., of Seattle, and the Parkinson's Institute and Clinical Center in Sunnyvale, Calif., said they are collaborating to evaluate an Omeros target in the treatment of movement disorders. Under the terms, they will conduct laboratory studies of one or more compounds that block the target in a predictive model for the symptomatic treatment of Parkinson's. Earlier studies by Omeros in a similar model showed that compounds blocking that target were as effective as levodopamine. Financial terms of the deal were not disclosed.

Peregrine Pharmaceuticals Inc., of Tustin, Calif., said Nasdaq informed the company that its request to remain listed has been granted, subject to the condition that Peregrine's stock closes at $1 per share for 10 consecutive trading days on or before Jan. 20, 2009.

SRI International, of Menlo Park, Calif., said it was awarded a contract to develop broad-spectrum antibiotics from the Defense Threat Reduction Agency of the Department of Defense. The three-year $8.3 million contract will enable preclinical research in developing drugs against a range of bioterror agents, including anthrax, plague and tularemia.

Three Rivers Pharmaceuticals LLC, of Cranberry Township, Pa., said it signed a definitive license agreement with Thousand Oaks, Calif.-based Amgen Inc. to expand its commercial rights to hepatitis C drug Infergen (interferon alfacon-1) to all markets except Japan. Three Rivers also will obtain commercial rights to China, effective March 31, 2009. Three Rivers currently has rights to Infergen in the U.S. and Canada. Financial terms were not disclosed.

http://www.therapeuticsdaily.com/news/article.cfm?contenttype=sentryarticle&contentvalue=1839204&channelID=31

AtheroGenics Inc., of Atlanta, restructured its board from 10 members to six to better align the size of its board with the current needs of the company.

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.

Whew, that was a lot of info....have a great day all, I am
stationed in a locale where internet access is few and far
between, until way later when we arrive back into a city
area.