|ARCA biopharma reaches SPA with FDA. FDA grants NeoPharm IPF drug Orphan Status. Aeterna Zentaris gains Orphan designation with EU for ovarian cancer drug|
|By BioMedReports.com Staff|
|Monday, 17 May 2010 18:10|
Below is a list of the companies that made news in the healthcare sector on Monday, May 17, 2010.
ARCA biopharma, Inc. (Nasdaq: ABIO) soared today after the company announced that it has reached agreement with the U.S. Food and Drug Administration regarding a Special Protocol Assessment (SPA) on the design of a clinical trial to assess the safety and efficacy of bucindolol in approximately 3,200 patients with chronic heart failure who have the genotype that appears to respond most favorably to bucindolol. Bucindolol is the Company’s investigational, pharmacologically unique, beta-blocker and mild vasodilator. An SPA is an agreement with the FDA that the proposed trial protocol design, clinical endpoints and statistical analyses are acceptable to support regulatory approval. In November 2009, the Company announced that the FDA has designated as a Fast Track development program the investigation of bucindolol for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population. In March 2010, ARCA was awarded a patent from the U.S. Patent and Trademark Office (USPTO) on methods of treating heart failure patients with bucindolol based on genetic testing.
"This SPA agreement with the FDA, the latest in a series of important milestones for ARCA, provides us with a clearly defined development and regulatory pathway for bucindolol in the treatment of genotype-specific heart failure patients," said Michael R. Bristow, President and Chief Executive Officer of ARCA. "We appreciate the FDA’s approach to identifying a means by which additional bucindolol effectiveness data can be generated in a genotype-defined heart failure population. If the planned study confirms previous observations made in the BEST trial, bucindolol has the potential to become the first genetically targeted heart failure treatment for what we estimate to be the approximately 1.5 million heart failure patients with systolic dysfunction and the genotype that appears to respond most favorably to bucindolol."
Shares of ARCA jumped more than 12% or 54 cents to close at $4.81. Shares at one point were up more than 30%, hitting $5.68 early in the trading day.
NeoPharm, Inc. (Other OTC: NEOL.PK), announced today that the Office of Orphan Products Development of the United States Food and Drug Administration has granted orphan-drug designation for IL13-PE38QQR (IL13-PE) for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
Dr. Aquilur Rahman, President and CEO, commented, "IPF is the most deadly disease of the lungs in humans with very high morbidity. It is estimated that about 55,000 patients are diagnosed with the disease and almost 45,000 of them die with this disease every year in the U.S. There is currently no proven effective treatment to cure this disease. All the studies that NeoPharm has performed in animals and in ex vivo human tissue have shown quite promising results. We look forward to starting our clinical studies with IL13-PE as aerosolized product in humans inflicted with this devastating disease quite soon."
Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) today announced that it has received a positive opinion for orphan medicinal product designation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency, for its compound AEZS-108 for the treatment of ovarian cancer. AEZS-108, the Company's doxorubicin targeted conjugate compound, is currently in a Phase 2 trial in advanced ovarian and advanced endometrial cancer in Europe.
Juergen Engel, Ph. D., President and CEO of Aeterna Zentaris stated, "We are very pleased with AEZS-108 gaining orphan medicinal product designation for ovarian cancer from European authorities, especially after having been recently granted orphan-drug designation by the FDA. This means that with both these orphan designations, AEZS-108 would be provided with extra market exclusivity protection in Europe as well as in the United States for the treatment of ovarian cancer. We now look forward to reporting the final results from our ongoing European Phase 2 study in ovarian and endometrial cancer, later this year."
In a separate release the company today announced publication of an article in the May 12th Journal of the National Cancer Institute, entitled "In Vitro and In Vivo Inhibition of Neuroblastoma Tumor Cell Growth by AKT Inhibitor Perifosine," demonstrating the single agent activity of perifosine (KRX-0401) in neuroblastoma tumor preclinical models. Neuroblastoma is the most common pediatric solid tumor. Perifosine, the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, is currently being investigated in a Phase 1 study as a single agent treatment for recurrent solid tumors, including neuroblastoma, in pediatric patients. Perifosine is licensed to Keryx Biopharmaceuticals (Keryx) (Nasdaq:KERX - News), in the United States, Canada and Mexico. Aeterna Zentaris has also out-licensed perifosine to Handok in South Korea, while retaining rights for the rest of the world. Perifosine is also currently in Phase 3 trials in multiple myeloma and colorectal cancer, as well as in Phase 2 trials for multiple types of cancer.
After the bell Monday:
A.P. Pharma, Inc. (NASDAQ: APPA) reported financial results for its first quarter ended March 31, 2010. "Our focus is on addressing the issues raised in the Complete Response Letter we received for APF530 in March 2010," stated Ronald Prentki, A.P. Pharma’s president and chief executive officer. "We are working with the U.S. Food and Drug Administration to schedule an End of Review meeting and have been diligently preparing our reply to the Complete Response Letter."
CEL-SCI Corporation (NYSE AMEX: CVM) after the bell reported financial results for the quarter ended March 31, 2010.
CEL-SCI reported that net loss for the three months ended March 31, 2010 was ($0.7 million) versus a loss of ($2.1 million) during the same three months in fiscal year 2009. Net loss per share was ($0.01) for the three months ended March 31, 2010 versus a loss of ($0.02) during the same three months in fiscal year 2009. The loss during the quarter ended March 31, 2010 was reduced by a gain on derivative instruments of $4.5 million. Geert Kersten, Chief Executive Officer said, "Expenditures during the past two quarters have been relatively high due to the preparations for the start of the pivotal Phase III trial with our cancer drug Multikine. Net cash used during the quarter totaled approximately $4 million. Despite this we concluded the March 31, 2010 quarter in a very strong financial condition, with more than $34 million in cash and cash equivalents. We are very pleased to have the ability to self-fund our upcoming pivotal study, expected to be the largest head and neck cancer Phase III trial ever conducted, and are working closely with our partners Teva Pharmaceuticals and Orient Europharma towards a successful launch."
Forest Laboratories, Inc. (NYSE: FRX) and Nycomed today announced that the U.S. Food and Drug Administration issued a complete response letter regarding the New Drug Application for roflumilast. Roflumilast was reviewed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations.
In the complete response letter the FDA requested certain additional information and analyses. No additional patient trials have been requested for the continued review of the NDA. Forest and Nycomed are committed to working with the FDA to address the outstanding matters and the companies anticipate a response to the FDA during the third calendar quarter of 2010.
Helicos BioSciences Corporation (NASDAQ: HLCS) after the bell announced that, as part of the Company’s previously disclosed efforts to consider alternatives to its existing long-term strategy, it is in the process of implementing a strategic shift to focus the business on the diagnostics markets. In connection with this effort, the Company has committed to a consolidation and reorganization of its operations in order to reduce operating costs. This restructuring plan has resulted in the elimination of approximately 40 positions during the current fiscal quarter. Approximately half of the Company’s 40 remaining employees are supported by NIH funding on research designed to further improve Helicos’ proprietary DNA and RNA single molecule sequencing technology.
Neuralstem, Inc. (NYSE Amex: CUR) today provided a financial and business update for the first quarter ended March 31, 2010. Richard Garr, Neuralstem's president and CEO said, "The first quarter of 2010 marked a major milestone for the Company as we moved into the clinic to treat ALS with our spinal cord neural stem cell therapy. We also completed the financings in the first quarter necessary to fund our transition into a clinical stage company.
NexMed, Inc. (Nasdaq: NEXM) after the bell today announced that the U.S. Food & Drug Administration has granted the Company an Investigational New Drug application number for its NexACT-based alprostadil treatment for Raynaud’s syndrome, ahead of a pre-IND meeting in mid-July 2010 to discuss its proposed Phase 2/3 protocol. The Company is in late stage development for Vitaros, its topically applied NexACT-based alprostadil treatment for erectile dysfunction.
Earlier in the day Monday:
AngioDynamics (NASDAQ:ANGO) announced today the launch of the first member of its new generation of peripherally inserted central catheters (PICCs) for procedures involving the use of contrast media in computed tomography (CT) – the Morpheus Smart PICC Triple Lumen CT PICC.
AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the U.S. Food and Drug Administration has acknowledged receipt of the Company’s Complete Response to the October 2006 Approvable Letter for Zenvia in the treatment of pseudobulbar affect (PBA). The FDA considers this a Class 2 response and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 30, 2010.
"If approved, Zenvia will be the first FDA approved treatment available for patients suffering from PBA," said Randall Kaye, AVANIR’s Chief Medical Officer. "We look forward to working closely with the agency during the upcoming months through the remaining stages of the review process."
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced the receipt of two US new patents directed to its 2A/Furin technology for expressing proteins. The first issued US patent, US Pat. No., 7,709,224, covers methods for manufacturing recombinant antibodies. By incorporating our 2A/Furin technology into antibody-expression in viral vectors it is possible to rapidly generate stable, high producing antibody cell lines. The subsequent cell lines may greatly reduce the time and lower the cost of commercial antibody production. The second issued US patent, US Pat. No. 7,714,199 covers additional adeno-associated virus (AAV) vectors containing the 2A/furin technology and methods for expressing antibodies in vivo using these vectors and builds on already issued patents covering vectors and methods for producing antibodies in vivo and in vitro. The two new patents expire in 2023.
Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that the first patient has been screened in a randomized Phase 2 study of the Company’s novel, first-in-class antibody-based vaccine candidate from its Precision Targeted Immunotherapy (PTI) platform. This study will evaluate the CDX-1307 regimen in both neoadjuvant and adjuvant settings in patients with newly diagnosed muscle-invasive bladder cancers that express hCG-beta. hCG-beta is a tumor-associated antigen (TAA) expressed by several different types of cancers, including bladder cancer. hCG-beta appears to directly facilitate cancer progression and has been shown to correlate with poor prognosis. CDX-1307 is a fully human monoclonal antibody designed to selectively deliver the hCG-beta antigen to dendritic cells. The CDX-1307 vaccine regimen, which includes a novel combination of immune stimulating adjuvants, was developed during Phase 1 trials and has been shown to generate a robust immune response against cancer cells expressing hCG-beta.
"Bladder cancer is an understudied disease with a real need for new therapies and hCG-beta is an important molecule in tumor biology that prevents tumor cell death," said Professor Ray Iles, Middlesex University, London. "CDX-1307 may be a very useful adjuvant therapy in this disease."
Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) today announced that it has entered into exchange agreements with certain holders of some of the Company's outstanding 4% Convertible Senior Subordinated Notes due 2010. The Company may exchange up to approximately 60 million shares of its common stock for up to approximately $30 million aggregate outstanding principal amount of Notes in one or a series of exchanges, which may be effected over several days.
China Biologic Products, Inc. (Nasdaq:CBPO) one of the leading plasma-based biopharmaceutical companies in the People's Republic of China, operating through its indirect majority-owned subsidiaries, Shandong Taibang Biological Products Co. Ltd. and Guiyang Dalin Biologic Technologies Co., Ltd. and its equity investment in Xi'an Huitian Blood Products Co., Ltd., today reported financial results for its first quarter ended March 31, 2010.
Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that it is entering the hemorrhoidopexy market for the first time with EEA Hemorrhoid & Prolapse Stapler Set with DST Series Technology. The new, innovative instrumentation features important advances in hemorrhoid stapler technology and design that address what surgeons say are their biggest challenges in performing the hemorrhoidopexy procedure.
Discovery Laboratories, Inc. (Nasdaq:DSCO) announced that data from a preclinical study using Discovery Labs' KL4 surfactant (lucinactant) in an established porcine model of lung transplantation demonstrated a potentially important protective role in a newly transplanted lung, reducing ischemia-reperfusion injury often seen after lung transplantation .
Emergent BioSolutions Inc. (NYSE:EBS) announced today that its Investigational New Drug (IND) application, to commence a Phase I clinical trial for its anthrax monoclonal antibody therapeutic, has cleared U.S. Food and Drug Administration review. The Phase I study will evaluate the safety and pharmacokinetics of the company’s fully human monoclonal antibody being developed as a parenteral post-exposure therapy for individuals who have symptoms of anthrax disease. In pre-clinical therapeutic studies, Emergent’s monoclonal antibody was found to be effective.
"Emergent is committed to advancing its anthrax franchise, which includes both vaccines and therapeutics that address the anthrax threat," said Stephen Lockhart, MRCP, senior vice president product development of Emergent BioSolutions. "The end goal is to strengthen the nation’s arsenal of medical countermeasures and provide products that will support the government’s biopreparedness efforts."
Harbor BioSciences, Inc. (Nasdaq:HRBR) today announced that new data from the Phase I/IIa clinical trial of the company's lead drug candidate Apoptone(R), its anticancer drug candidate being developed for prostate cancer, will be presented as part of the Scientific Program in a General Poster Session at the American Society of Clinical Oncology (ASCO) Annual Meeting June 4 -- 8, 2010. Apoptone is a novel synthetic steroid analog of a dihydrotestosterone metabolite and has been found to induce cell death (apoptosis) in animal models of prostate and breast cancers.
Hemispherx Biopharma, Inc. (NYSE Amex:HEB), announced an agreement with Fountain Medical Development Ltd., a leading Chinese clinical research organization to prepare, file and gain approval from the authorities in China to conduct a study of Ampligen, an investigational therapeutic. Ampligen is a member of a new class of antivirals/ immuno-potentiators with broad spectrum therapeutic properties. Hemispherx plans to investigate the experimental therapeutic for potential treatment of seriously ill hospitalized flu patients, many with underlying respiratory conditions. The proposed study will determine the extent to which their clinical parameters return to normal more rapidly with potential shortening of their hospital stay relative to patients treated only with placebo plus the existing "standards of care". Hemispherx has engaged Fountain with a plan to initiate this study during next year's flu season in various parts of China.
ImmunoCellular Therapeutics (OTCBB: IMUC), a clinical-stage biotechnology company that is developing immune based therapies for the treatment of brain and other cancers, announced today that the Company and Torrey Pines Institute for Molecular Studies in San Diego, CA have identified several peptides which can generate CD-133 specific T-cells. CD-133 is found in high abundance on cancer stem cells ("CSCs") which makes it promising for immunological targeting.
Inovio Biomedical Corporation (NYSE Amex: INO), a leader in the development of new preventive and therapeutic vaccines against cancers and infectious diseases, announced today that it has changed its corporate name to Inovio Pharmaceuticals, Inc. by filing a Certificate of Amendment to its Certificate of Incorporation with the Secretary of State of the State of Delaware on May 14, 2010. Inovio’s trading symbol remains the same.
"In the last year Inovio has made great strides in advancing its DNA vaccines for influenza, HIV and cancer and its proprietary vaccine delivery technology. The new name better reflects the company’s product development leadership in unlocking the promise of DNA vaccines," said Dr. J. Joseph Kim, President & CEO.
Protalix BioTherapeutics, Inc. (NYSE-AMEX: PLX), announced today that the Office of the Chief Scientist (OCS) of Israel's Ministry of Industry, Trade and Labor has awarded the Company a grant of up to $4.1 million for calendar year 2010. The OCS awarded the grant to the Company to promote the advancement of the Company's drug development programs. "We are enthused by the continued support of the OCS in our development efforts. With the influx of capital the Company has received over the past six months, we are intensely focused on aggressively developing our pipeline product candidates, all of which are stemming from our proprietary ProCellEx protein expression system," said Dr. David Aviezer, President and Chief Executive Officer of the Company.
RXi Pharmaceuticals Corporation (Nasdaq: RXII), today reported its financial results for the quarter ended March 31, 2010.
"We have continued to make excellent progress in all aspects of our business including advancing our rxRNA therapeutic platform, establishing important industry and academic collaborations, significantly strengthening our balance sheet, and reporting outstanding preclinical data in multiple therapeutic areas," said Noah Beerman, President and Chief Executive Officer of RXi. "As we move forward, 2010 promises to be a pivotal and transitional year for RXi, enabling us to evolve from a research-focused company to one identified by compelling product development programs, a focused therapeutic strategy, and validating corporate partnerships."
SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN) today announced further topline results from the company's phase 2 proof of concept study of SCV-07 for the prevention of severe oral mucositis in patients with advanced head and neck cancer -- a painful and debilitating condition caused by chemoradiotherapy regimens.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced results from the Phase II ALSTAR trial. The trial was designed to assess efficacy, safety and tolerability of Talampanel (a selective AMPA antagonist) in reducing disease-related functional deterioration in Amyotrophic Lateral Sclerosis (ALS) patients. Results indicate that while Talampanel was safe for ALS patients, the study did not meet its primary endpoint."Despite our hopes to advance the treatment of this debilitating disease, Talampanel did not succeed in demonstrating the required efficacy, although safety was established," said Moshe Manor, Teva's Group Vice President, Global Branded Products. "Broadening our innovative pipeline – through internal R&D, licensing and other business development activities – is part of our long term strategy. This outcome has no impact on our 2015 innovative goal."
ViroPharma Incorporated (Nasdaq:VPHM) today announced that it has begun packaging Cinryze, its product proven to prevent attacks of hereditary angioedema (HAE), with West Pharmaceutical Services, Inc.'s (NYSE:WST) Mix2Vial needle-less reconstitution system. This simple-to-use reconstitution device and accompanying training materials will be widely available in the coming weeks. Cinryze was approved by the U.S. Food and Drug Administration in October 2008 for routine prophylaxis against hereditary angioedema (HAE) attacks in adolescents and adults.
AcuMedSpa Holdings, Inc. (PINKSHEETS:AMSZ), a provider of Medical Aesthetic, Spa and Acupuncture services, announces corporate updates and reiterates goals for 2010.
Amarillo Biosciences, Inc. (OTCBB:AMAR) today announced additional positive results from a Phase 2 clinical trial conducted at the University of Western Australia.
Aradigm Corporation (OTCBB: ARDM) today announced it is presenting data on clinical trials with its ciprofloxacin for inhalation formulations, ARD-3100 and ARD-3150, in healthy volunteers and non-cystic fibrosis (CF) bronchiectasis (BE) patients at the 2010 International Conference of the American Thoracic Society in New Orleans, LA.
Baxter International Inc. (NYSE:BAX) announced today that a voluntary recall of all manufactured lots of HYLENEX recombinant (hyaluronidase human injection) has been initiated as a precautionary measure due to instances of particulate matter observed in a limited number of HYLENEX vials during routine stability testing.
BioPharm Asia, Inc. (OTCBB: BFAR), a producer, distributor and retailer of medical products in China, today announced its financial results for the first quarter ended March 31, 2010.
Biostar Pharmaceuticals, Inc. (Nasdaq: BSPM), a Xianyang- based manufacturer of a leading over-the-counter Hepatitis B medicine, Xin Aoxing Oleanolic Acid Capsules, and a variety of pharmaceutical products, today announced financial results of the first quarter ended March 31, 2010.
Bohai Pharmaceuticals Group, Inc. (OTCBB: BOPH), a China-based pharmaceutical company engaged in the production, manufacturing and distribution of Traditional Chinese Medicine in China, today reported financial results for the fiscal third quarter and nine months ended March 31, 2010.
Cadus Corporation (OTCBB: KDUS) announced today financial results for the first quarter ended March 31, 2010.
C.H. Robinson Worldwide, Inc. (Nasdaq: CHRW) announced today that its Board of Directors has appointed a new director, David W. MacLennan, effective August 12, 2010. MacLennan, 50, currently is senior vice president and chief financial officer of Cargill, Incorporated and also serves as a member of the Cargill Board of Directors.
Cortex Pharmaceuticals, Inc. (OTCBB:CORX) reported net income of approximately $5,596,000, or $0.08 per share for the quarter ended March 31, 2010 compared with a net loss of $3,168,000, or $0.07 per share for the corresponding prior year period, with the difference reflecting revenues from the Company's March 2010 transaction with Biovail Laboratories International SRL (Biovail).
Dehaier Medical Systems Ltd. (Nasdaq: DHRM), an emerging leader in the development, assembly, marketing and sale of medical products in China, said today that it has become the exclusive China distributor of Welch Allyn's patient monitors.
Highwoods Properties, Inc. (NYSE: HIW), the largest owner and operator of suburban office properties in the Southeast, today announced that it has expanded its relationship with INC Research®, Inc., a therapeutically focused contract research organization that conducts global clinical development programs.
Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced today that it will conduct the third of its series of four conference calls focused on the drugs in Isis' development pipeline.
NanoViricides, Inc. (OTC BB: NNVC.OB), announced that it has signed a Research Agreement with the University of California, San Francisco (UCSF) for testing of its anti-HIV drug candidates. Cheryl Stoddart, PhD, Assistant Professor in the UCSF Division of Experimental Medicine, will be the Principal Investigator.
NovaDel Pharma Inc. (OTCBB: NVDL), a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed treatments, reported financial results for its first quarter ended March 31, 2010.
Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX), a specialty pharmaceutical company primarily focused on the pediatric marketplace, today announced results for the first quarter ended March 31, 2010.
Repros Therapeutics (NasdaqCM: RPRX) today announced the results of the proxy vote provided by the shareholders at its 2010 Annual Meeting as pertaining to the proposals set forth in the Company's proxy statement.
Shengtai Pharmaceutical, Inc. (OTC Bulletin Board: SGTI), a manufacturer and distributor in China of glucose and starch as pharmaceutical raw materials and other starch and glucose products, today reported its financial results for the third quarter and the first nine months of fiscal year 2010 ended March 31, 2010.
Soligenix, Inc. (OTC Bulletin Board: SNGX), a late-stage biopharmaceutical company, announced today its financial results for the first quarter of 2010.
Spring Creek Capital Corporation (OTCBB: SCRK), a healthcare solutions company whose business plan is distributing cutting edge solutions for the medical, pharmaceutical and healthcare markets, today announced the appointment of healthcare industry veteran and former Program Manager at the Stanford Research Institute International, Randall E. McCoy, to its board of directors.
Talecris Biotherapeutics Holdings Corp. (Nasdaq: TLCR) announced today that the company has been added to the NASDAQ Biotechnology Index® ( NBI).
Tiens Biotech Group (USA), Inc. (NYSE AMEX: TBV) today announced financial results for the first quarter ended March 31, 2010.
UV Flu Technologies, Inc. (OTCBB:UVFT) announced that the latest production order of the Company's flagship Indoor Air Quality ("IAQ") product known as the ViraTech UV-400 Air Purifier, has been completed and the first containerized shipment from China will commence shortly.
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