FDA and EMA to re-analyze Repligen study data. Dynavax to continue Hep B study Print E-mail
By BioMedReports.com Staff   
Thursday, 27 May 2010 19:36
Below is a list of the companies that made news in the healthcare sector on Thursday, May 27, 2010.

Repligen Corporation (Nasdaq:RGEN) announced today that the Food and Drug Administration and the European Medicines Agency have approved the Company's proposal to re-analyze the images from our Phase 3 study to establish the utility of RG1068, synthetic human secretin, in improving magnetic resonance imaging (MRI) of the pancreas (Phase 3 re-read). The FDA and EMA have agreed to the Phase 3 re-read based on the numerous deficiencies with the analysis of the radiographic images by the contract research organization hired to oversee analysis of the Phase 3 data. A successful re-read of the Phase 3 data may support registration of RG1068 for MRI imaging of the pancreas. The goal of the Phase 3 study is to evaluate the sensitivity and specificity of RG1068 in combination with MRI to improve the detection of structural abnormalities of the pancreatic ducts relative to MRI alone. Detailed visual assessment of the pancreatic ducts is important in the assessment, diagnosis and treatment of diseases such as acute and chronic pancreatitis.

"We are very pleased with the response of the FDA and EMA to our re-read proposal," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen. "Based on the positive feedback we received from both regulatory agencies, we believe that a successful re-read may provide the basis for registration, and we have no plans to initiate additional clinical studies of RG1068 in this indication. Pending finalization of the protocol, we anticipate completing the Phase 3 re-read by the end of the year."

Shares of Repligen shot up nearly 10% on the news, closing the day at $3.50, up 31 cents.

Dynavax Technologies Corporation (NASDAQ:DVAX ) jumped higher today after the company announced that the Data Safety Monitoring Board (DSMB) established for Dynavax's two ongoing Phase 3 trials for HEPLISAV has completed the second of its planned safety assessments. The evaluation included data from 2,264 subjects that received their first injection, 1,611 of whom received their first and second injections. The DSMB determined that the studies may continue without modification.

HEPLISAV is an innovative vaccine designed to protect against hepatitis B infection. The DSMB reviewed safety data from two ongoing multi-center Phase 3 trials evaluating HEPLISAV, one trial in adults 40 years and older, and a second trial in chronic kidney disease patients. The DSMB is comprised of an independent group of medical experts who are responsible for reviewing and evaluating subject safety data at regular intervals during the ongoing trials.

Shares of Dynavax rose more than 7%, closing the day at $1.73

Accuray Incorporated (Nasdaq:ARAY), a global leader in the field of radiosurgery, today announced the installation of the first CyberKnife VSI System at Creekside Cancer Care in Lafayette, Colo. The CyberKnife VSI System is the newest addition to the CyberKnife product family that will allow the Creekside Cancer Care center to offer expanded cancer treatment options from radiosurgery to high-precision radiation therapy. The center expects to begin treating patients with the CyberKnife VSI System in June.

BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that it has entered into a license and supply agreement with Kunwha Pharmaceutical Co., Ltd., for the exclusive rights to develop and commercialize BEMA Fentanyl (marketed as ONSOLIS in the U.S.) in the Republic of Korea. The agreement results in potential milestone payments to BDSI of up to $1,275,000, which includes an upfront payment of $300,000. In addition, BDSI will receive an ongoing royalty based on net sales.

BioTime, Inc. (AMEX:BTIM) moved higher today after announcing that on June 1, 2010 the Company will be offering for sale five new human stem cell lines for research use only. These cell lines were developed using BioTime’s ACTCellerate technology. These highly purified, novel, and scalable cell lines are embryonic progenitors, meaning that they are intermediate between human embryonic stem cells and fully developed cells. The new lines will include W10 with markers of smooth muscle progenitors, RASMO12 with unique markers associated with the kidney, U31 with markers associated with the neurotransmitter dopamine useful in research in Parkinson’s disease and diseases of the autonomic nervous system, as well as the lines SK11, EN1, and 7SMOO7, properties of which will be disclosed on product launch.

Celgene Corporation (NASDAQ: CELG) announced that as a result of Barr Laboratories, Inc., withdrawing its Abbreviated New Drug Application (ANDA) for thalidomide with the US Food and Drug Administration, the US District Court for the District of New Jersey has granted the requested dismissal of all claims and counterclaims in the thalidomide patent cases.

Cyberonics, Inc. (Nasdaq:CYBX) today announced the results of a multicenter, double-blind, randomized dosing study (D-21) conducted as a condition of the Food and Drug Administration (FDA) approval for VNS Therapy for patients with chronic and recurrent treatment-resistant depression in July 2005. This dosing study showed a consistent, sustained and clinically meaningful decrease in depression symptoms across all treatment groups as measured by multiple validated depression assessment scales. Four physician-rated depression scales and one patient-rated depression scale used in this study showed that adjunctive VNS Therapy provided efficacy that improved over time at all dosing levels. After long-term (50 weeks) treatment with VNS Therapy, overall depression symptom improvement ranged from 32.4% to 42.0%; response rates ranged from 26.7% to 53.3%; and remission rates ranged from 14.6% to 22.5% as measured by the five depression assessment scales.

Cytokinetics, Incorporated (NASDAQ:CYTK) announced today that the company has opened to enrollment a Phase IIa "Evidence of Effect" (EoE) clinical trial of CK-2017357 in patients with peripheral artery disease and claudication. CK-2017357 is a fast skeletal muscle troponin activator and the lead drug candidate from the company's skeletal muscle contractility program. CK-2017357 selectively activates the fast skeletal muscle troponin complex and increases its sensitivity to calcium, resulting in increased skeletal muscle force and slowing of time to muscle fatigue.

CytRx Corporation (NASDAQ:CYTR), today announced that its drug candidate bafetinib (formerly known as INNO-406) demonstrated statistically significant inhibition of glioblastoma multiforme cell lines in a preclinical trial. Glioblastoma multiforme is the most common and aggressive primary adult brain tumor. Data from the trial, titled "Preclinical evaluation of Lyn kinase inhibition for treatment of glioblastoma multiforme," will be presented in a poster at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) being held June 4-8.

Daxor Corporation (AMEX:DXR), a medical instrumentation and biotechnology company, today announced the publication of a review article in the journal US Cardiology titled, "Blood Volume Analysis Coupled with Ultrafiltration in the Management of Congestive Heart Failure - Guided Therapy to Achieve Euvolemia." This article reviews the potential use of blood volume analysis to guide fluid removal by ultrafiltration in congestive heart failure patients. Heart failure patients with expanded blood volumes have been shown to have significantly reduced survival relative to patients with normal volume status: A 2004 study from the Columbia Presbyterian Medical Center showed a significant survival advantage for those heart failure patients who were normal or minimally hypovolemic compared to those who were hypervolemic.

Ophthalmic Imaging Systems (OTC.BB:OISI), a leading ophthalmic digital imaging and informatics company, today announced it has raised $2.0 million from the second and final installment under a June 2009 purchase agreement with U.M. AccelMed, LP.

OXiGENE, Inc. (Nasdaq:OXGN) (Stockholm:OXGN), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced publication of preclinical data on its second-generation, dual-action vascular disrupting agent (VDA) OXi4503 that demonstrate potent activity against acute myeloid leukemia (AML).

Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM), moved higher today after the company announced positive objective tumor response and median progression-free survival (PFS) data from a Phase II trial evaluating bavituximab in combination with paclitaxel and carboplatin chemotherapy in patients with advanced breast cancer. These data will be highlighted in a poster presentation on June 5, 2010 at the 2010 ASCO Annual Meeting.

"The overall tumor response of 74% of patients in this study and median PFS of 6.9 months are promising results in this breast cancer patient population," commented Minish Jain, M.D., an investigator of this trial and oncologist at the Ruby Hall Clinic in Pune, India. "These results demonstrate the potential of bavituximab to be used in combination with paclitaxel and carboplatin in the treatment of solid tumors such as advanced breast cancer."

Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced the presentation of preclinical data on novel monoclonal antibodies against toxins produced by the bacterium Clostridium difficile (C. difficile). The monoclonal antibodies effectively neutralized the cell-killing activities of the toxins in vitro and significantly improved survival in a stringent animal model of C. difficile infection. C. difficile is the leading cause of hospital-acquired diarrhea in the United States and represents a growing global public health challenge. The monoclonal antibodies were identified as part of the Company’s ongoing drug discovery efforts in infectious diseases.

SonoSite, Inc. (NASDAQ: SONO), the world leader and specialist in bedside and point-of-care ultrasound, today announced that it has signed an agreement to acquire privately held Visualsonics, a Toronto-based company focused on ultra high-frequency micro-ultrasound technology. The aggregate transaction value will be approximately $71 million net of cash and debt.Visualsonics is the technology leader in real-time ultra high-frequency micro-ultrasound that presently serves the rapidly growing pre-clinical research market.

YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM), today announced that the first US patient has been enrolled in its randomized, double-blind trial evaluating nimotuzumab in patients with brain metastases from NSCLC at the Florida Cancer Institute - New Hope. This trial initiation follows recent clearance from the US FDA announced on January 26, 2010 allowing the Company to enroll patients at US clinical sites for two of its international and ongoing randomized, double-blind Phase II trials of nimotuzumab. YM anticipates that patients will also begin to be enrolled in the near future in its trial in patients with NSCLC ineligible for curative treatment and who are being treated with radiotherapy palliatively.

ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP) today announced the pricing of an underwritten public offering of 7,000,000 shares of its common stock at a price to the public of $5.00 per share. The net proceeds from the sale of the shares, after underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $32.8 million.

Also Thursday:

BioClinica, Inc., (NASDAQ: BIOC), a global provider of clinical trial management services, today announced it will exhibit and present at several key, upcoming healthcare conferences scheduled during June and July.

Bristol-Myers Squibb Company (NYSE:BMY) will host a teleconference at 8:00 a.m. EDT on Monday, June 7, 2010, to review data presented at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

China Sky One Medical, Inc. (Nasdaq: CSKI), a leading fully integrated pharmaceutical company producing over-the-counter drugs in the People's Republic of China ("PRC"), today announced that its Tian Long Pharmaceutical Company ("Tian Long") subsidiary successfully obtained renewal of its Good Manufacturing Practices Certificate for Pharmaceutical Products ("GMP Certificate") from the State Food and Drug Administration (SFDA) in China. The new certificate will be valid until May 2015.

GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines, announced today The AIDS Research Consortium of Atlanta (ARCA) has received approval to begin enrollment of the first therapeutic trial ever conducted using a promising HIV vaccine candidate from GeoVax, Inc.

Gilead Sciences, Inc. (Nasdaq:GILD) today announced that its corporate presentation will be webcast from the Sanford C. Bernstein 26th Annual Strategic Decisions Conference in New York.

iCAD, Inc. (Nasdaq: ICAD), an industry-leading provider of advanced image analysis and workflow solutions for the early identification of cancer, today announced the launch of a new version of its VeraLook computer-aided detection (CAD) technology for CT colonography (CTC), or Virtual Colonoscopy.

IGEN Networks Corp. (IGEN: OTCBB) announces it will undertake a non-brokered Private Placement for $2,000,000 with the issuance of 2,500,000 shares at $.80 per share, as approved by the Board of Directors.

Maxygen, Inc. (Nasdaq:MAXY), a biotechnology company focused on the development of improved protein drugs, today announced a stock repurchase program under which the company may purchase up to $10 million of its common stock through December 31, 2010.

Luminex Corporation (Nasdaq: LMNX), the worldwide leader in multiplexed solutions, announced today that management will present at two upcoming investor conferences, the Jefferies 2010 Global Life Sciences Conference, and the William Blair 30th Annual Growth Stock Conference.

PharMerica Corporation (NYSE: PMC) announced the results of the Company's 2010 annual meeting of stockholders held on Wednesday, May 26, 2010.

PPD, Inc. (Nasdaq: PPDI) announced today that, in connection with its proposed spin-off of Furiex Pharmaceuticals, Inc., the Securities and Exchange Commission has declared effective Furiex Pharmaceuticals' Registration Statement on Form 10.

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that it intends to offer, subject to market and other conditions, $200 million aggregate principal amount of its convertible senior notes due 2015 under an automatically effective shelf registration statement on file with the Securities and Exchange Commission.

Switzerland--Roche (Pink Sheets:RHHBY) (SWX:RO) (SWX:ROG), announced today the global launch of the GS Junior System, the company's new benchtop next-generation DNA sequencing platform for life science research.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

 




"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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