|XenoPort surges on drug update. Synta expands trial. Otix Global acquired, shares double. After the bell: Ironwood soars, Icagen falls.|
|By BioMedReports.com Staff|
|Monday, 13 September 2010 17:51|
Below are some of the newsmakers in the healthcare sector on Monday, September 13, 2010.
After the bell Monday, Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest Laboratories, Inc. (NYSE: FRX) today announced positive top-line results from the first of two Phase 3 clinical trials assessing the efficacy and safety of the investigational drug, linaclotide, in patients with irritable bowel syndrome with constipation (IBS-C). Analyses of the data indicate clinically meaningful and statistically significant improvement was achieved for linaclotide-treated patients compared to placebo-treated patients for all four primary efficacy endpoints, which included two composite responder endpoints encompassing abdominal pain and complete spontaneous bowel movements (CSBMs), as well as individual responder endpoints for abdominal pain and CSBMs. Significant improvement was also achieved for linaclotide-treated patients compared to placebo-treated patients for all pre-specified secondary endpoints, which are measures of abdominal pain, abdominal discomfort, bloating, and bowel symptoms. The safety results were consistent with those observed in previous linaclotide trials, with diarrhea being the most common adverse event in linaclotide-treated patients. A second Phase 3 trial of linaclotide in IBS-C is ongoing with top-line results expected in Q4 2010.
In the after hours market, shares of Ironwood surged more than 24%, trading up $2.25 to $12.15. Shares of Forest Labs rose nearly 5%.
Icagen, Inc. (Nasdaq:ICGN) today after the bell announced that due to the occurrence of a serious adverse event in the photosensitivity study of ICA-105665, the Company has suspended further enrollment in the study. The serious adverse event occurred in the 600mg patient cohort following completion of the 500mg patient cohort. The Company will be discussing the status of the study with its clinical advisors and with the FDA. Additionally, the Company has completed the conduct of the multiple ascending dose study in healthy volunteers at daily doses of 500mg and 600mg for a period of seven days. There have been no serious adverse events noted, pending a final review of laboratory data. Analyses of the complete data set from both studies are ongoing.
Shares of Icagen fell more than 17% in extended trading Monday.
XenoPort, Inc. (Nasdaq:XNPT) announced today that it plans to move arbaclofen placarbil (AP), also known as XP19986, into Phase 3 development as a potential treatment of spasticity in multiple sclerosis (MS) patients. Following discussions with the U.S. Food and Drug Administration (FDA), XenoPort intends to conduct a single placebo-controlled Phase 3 efficacy clinical trial and an open-label, long-term, safety study of AP in patients with MS. Favorable results from these studies could lead to the filing of a new drug application (NDA) with the FDA under Section 505(b)(2) seeking approval of AP for the treatment of spasticity.
Ronald W. Barrett, chief executive officer of XenoPort, stated, "In our previous Phase 2 clinical trial in spinal cord injury patients with spasticity, AP was well tolerated and demonstrated dose-dependent improvement in muscle tone that was maintained throughout the twelve-hour dosing interval. We hope to demonstrate similar results in our Phase 3 trial of AP in MS patients with spasticity."
Randall Schapiro, M.D., Clinical Professor of Neurology at the University of Minnesota and President of the Schapiro Multiple Sclerosis Advisory Group, stated, "Available treatments do not fully address the needs of MS patients with spasticity. Baclofen is often used in these patients, but its short duration of action and central nervous system side effects can result in sub-optimal therapy. A new oral medicine that could maintain efficacy with limited adverse events would be a welcome addition to the spasticity treatment armamentarium."
XenoPort intends to initiate this Phase 3 clinical program in the first half of 2011.
Shares of XenoPort soared on the news, jumping $1.35 or nearly 22% to $7.55.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that it was expanding its Phase 2 clinical trial of STA-9090 in patients with Stage IIIB and Stage IV non-small cell lung cancer (NSCLC) from up to 69 patients to up to 146 patients based on encouraging activity observed in the first stage of the two stage clinical trial. STA-9090 is a potent, second-generation, small-molecule Hsp90 inhibitor, with a chemical structure unrelated to the first-generation, ansamycin family of Hsp90 inhibitors.
"This NSCLC trial is enrolling patients into cohorts defined by the mutational status of key genes in order to identify cancer types especially responsive to STA-9090," said Vojo Vukovic, M.D., Ph.D., Senior Vice President and Chief Medical Officer, Synta Pharmaceuticals. "In the first stage of this trial we have seen exactly that; patients with EGFR and KRAS wild type, representing over 70% of all NSCLC, have shown a high disease control rate, over 70%. This early signal, combined with the objective responses seen following treatment with STA-9090, is very encouraging, particularly as the patients have been heavily pretreated and are refractory to many standard of care drugs.
On 3 times the daily average volume, shares of Synta surged more than 17% or 55 cents, closing the day near the HOD at $3.72.
Otix Global, Inc. (Otix) (Nasdaq:OTIX), a leading provider of hearing care services and solutions and the parent company of Sonic Innovations, Inc. (Sonic) and HearingLife, today announced that it has entered into a definitive merger agreement with William Demant Holding A/S (WDH), the parent company of hearing aid companies, Oticon and Bernafon. Under the merger agreement WDH will pay $8.60 for each outstanding share of Otix common stock.
"In a short period of time, Otix Global has grown from an innovative start-up company to a leading manufacturer and distributor of superior hearing solutions under its Sonic and HearingLife brands. Our product lines have garnered industry attention and awards and are representative of the innovative technology for which Otix is known," said Otix Chairman and CEO Sam Westover. "The merger with William Demant will provide the research and development, marketing and sales support and resources necessary to further expand Sonic and HearingLife's presence in the hearing healthcare industry."
The proposed transaction represents a 112% and 125% premium to Otix's 5-day and 30-day average stock prices, respectively, as of the last trading day before the merger announcement. The boards of directors of Otix and WDH have given their approvals to the transaction, which is subject to German and Australian merger control regulations, and other customary closing conditions. The agreement will require the approval of Otix's shareholders. It is anticipated that the merger will be completed between mid-November and the end of 2010.
Shares of Otix doubled down on the news, rising $4.30 or 106% to $8.34.
Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC), (Nasdaq:CYCCP), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a pivotal Phase 3 trial for the Company's sapacitabine oral capsules as a front-line treatment in elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy.
"The SPA agreement with FDA represents an important milestone for Cyclacel and provides a clear registration pathway for sapacitabine," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "If it reaches the market, sapacitabine would be the first orally-administered drug to be offered to this patient population with the potential to serve as induction, consolidation and maintenance treatment of this life-threatening disease. In addition to progressing to Phase 3 in AML, we look forward to reporting sapacitabine Phase 2 data in myelodysplastic syndromes (MDS) and non-small cell lung cancer (NSCLC)."
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced the initiation of the pivotal Phase 2 clinical trial of its investigational pan-BCR-ABL inhibitor, ponatinib (previously known as AP24534), in patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia positive acute lymphoblastic leukemia (Ph+ ALL). The PACE (Ponatinib Ph+ ALL and CML Evaluation) trial is designed to provide definitive clinical data for regulatory approval of ponatinib in this setting. Ponatinib has been granted orphan drug status in both the United States and Europe for the treatment of CML and Ph+ ALL.
CEL-SCI Corporation (NYSE AMEX: CVM) announced today it has received approval from the North Mississippi Health Services Institutional Review Board ("IRB") to begin enrollment of subjects for a Phase III clinical trial of Multikine, the Company’s flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. An IRB is a group formally designated by an institution to review and monitor research involving human subjects and to ensure protection of their rights and welfare. On heavy volume shares of CEL-SCI rose more than 10%.
Laboratory Corporation of America Holdings (NYSE: LH), today announced that it has entered into a definitive agreement under which LabCorp will acquire Genzyme Genetics, a business unit of Genzyme Corp. (NASDAQ: GENZ), in an all cash transaction valued at $925 million. Net of expected income tax benefits, less acquisition-related expenses, the acquisition has a net cash cost to LabCorp of approximately $795 million.
Marina Biotech, Inc. (NASDAQ:MRNA), a leading RNA-based drug discovery and development company, today reported results from in vivo studies in rodent cancer models focused on effective delivery of a microRNA (miRNA) mimetic using Marina Biotech's proprietary Di-Alkylated Amino Acid (DiLA2) delivery system. Organ and tumor distribution studies demonstrated up to a 100-fold increase in miRNA copies per tumor cell as compared to baseline levels. Similar increases in the miRNA levels were noted in liver, lung, and heart after systemic administration of the mimetic formulated in DiLA2-based liposomes. Moreover, delivery of the miRNA mimetic in DiLA2 liposomes demonstrated approximately 60% knockdown of mRNA for two genes whose down-regulation is the intended target of the miRNA mimetic. "These data highlight the significant breadth in the potential uses of Marina Biotech's DiLA2 delivery system for RNA-based therapeutics," said J. Michael French, President and CEO of Marina Biotech.
Positron Corporation (OTCBB:POSC), a molecular imaging company specializing in Nuclear Cardiology and a leader in Cardiac PET, announced today the grand opening of its Clinical and Technical Cardiovascular PET Training Institute in Niagara Falls, NY.
The training center will educate physicians, technologists, nurses and administrators on the use and benefits of cardiac PET imaging in the daily operations of their facility. The training will be done in a partnership with the Heart Center of Niagara where Positron's medical director, Michael E. Merhige, M.D., F.A.C.C currently operates a Coronary Artery Disease Reversal and Prevention Center guided by Positron PET imaging technologies.
Pro-Pharmaceuticals, Inc. (OTC: PRWP), the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced that it has engaged the Numoda Corporation, a leading information, process and logistics management company, to oversee the Phase III clinical trial of DAVANAT and 5-FU compared with the standard of care in the treatment of patients with advanced, metastatic colorectal cancer.
Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced the appointment of Peter Brandt and Richard Kivel to the company’s board of directors.
RTI Biologics Inc. (RTI) (Nasdaq: RTIX), a leading provider of orthopedic and other biologic implants, and Athersys Inc. (Athersys) (Nasdaq: ATHX), a leader in regenerative medicine and cell therapy research and development, announced today an agreement under which Athersys will provide RTI access to its Multipotent Adult Progenitor Cell (MAPC) technologies.
Under the agreement, RTI has licensed Athersys’ technology to isolate and preserve cells from organ and tissue donors. This will enable RTI to develop and commercialize MAPC technology-based biologic implants exclusively for certain orthopedic applications. With this license, RTI expands its capabilities for accessing the fastest growing segment of the bone graft substitutes market, while Athersys extends the application of its robust stem cell technology platform to an important segment of the orthopedic market.
Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that its phase IIb clinical trial of lintuzumab (SGN-33) in older patients with acute myeloid leukemia (AML) did not meet its primary endpoint of extending overall survival. Lintuzumab is a naked monoclonal antibody that targets the CD33 antigen. As a result of the outcome of this trial, the company will discontinue its development program for lintuzumab.
"We are disappointed that lintuzumab did not demonstrate a survival benefit for older AML patients in this study. These patients have limited therapeutic alternatives due to their inability to tolerate the toxicities associated with standard high-dose chemotherapy, representing a substantial unmet medical need," said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. "We want to thank the patients, caregivers and investigators for their participation and commitment to the clinical evaluation of lintuzumab."
Theravance, Inc. (NASDAQ:THRX) today announced that data from the RELOVAIR program will be presented by GlaxoSmithKline (GSK) at the European Respiratory Society (ERS) Annual Congress, September 18-22, 2010 in Barcelona, Spain. RELOVAIR is being developed as a once-daily treatment combination of a long-acting beta agonist, vilanterol trifenatate (VI), and an inhaled corticosteroid, fluticasone furoate (FF) for patients with chronic obstructive pulmonary disorder (COPD) or asthma.
Vical Incorporated (Nasdaq:VICL) announced today the achievement of key efficacy, immunogenicity and safety results in a Phase 2 trial, establishing its TransVax(TM) cytomegalovirus (CMV) vaccine as the first to provide evidence of protection in immunocompromised hematopoietic cell transplant (HCT) recipients, and defining a potential pathway for further development.
Ardea Biosciences, Inc. (Nasdaq:RDEA) announced today that the Company will present at the following upcoming investor conferences: Stifel Nicolaus 2010 Healthcare Conference in Boston, Massachusetts.
Arena Pharmaceuticals, Inc. (Nasdaq:ARNA) today announced it will host a conference call and webcast on Friday, September 17, 2010, at 7:00 a.m. Eastern Time (4:00 a.m. Pacific Time) following the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee meeting.
BSD Medical Corporation (NASDAQ:BSDM) (BSD or the Company) today reported publication of an article on BSD's pioneering development of sophisticated technology o improve the delivery of heat therapy for the treatment of certain cancerous tumors.
Biomagnetics Diagnostics Corp., (PINK SHEETS:BMGP) a developer of revolutionary diagnostic systems and technology for HIV, hepatitis, tuberculosis and malaria detection, and other innovative technologies, today announced it has completed its formal purchase agreement to acquire Zhuhai Oil Energy Science and Technology Ltd., an inventor and producer of unique gasoline and diesel biofuel blends, located in Guangdong Province, China. Biomagnetics intends to close on the acquisition during the CEO's trip to China this week.
BioReference Laboratories, Inc. (NASDAQ:BRLI) announced today that Marc D. Grodman M.D., President and Chief Executive Officer, is scheduled to speak at the 2 10 UBS Global Life Sciences Conference on Monday, September 20, 2010, at The Grand Hyatt Hotel located in New York, NY.
Pharming Group NV (NYSE Euronext: PHARM) today announced that it has entered into an agreement with specialty biopharmaceutical company Santarus, Inc ("Santarus") (NASDAQ: SNTS) for the commercialization of Rhucin® (recombinant human C1 inhibitor; Ruconest in Europe) in North America (the United States, Canada and Mexico) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE) and other future indications.
Bristol-Myers Squibb Company (NYSE: BMY) will present at the UBS Global Life Sciences Conference Monday, September 20, 2010, in New York. Beatrice Cazala, senior vice resident, Commercial Operations, and president, Global Commercialization, Europe and Emerging Markets, will make a presentation about the company at 11:00 a.m. EDT.
Champions Biotechnology, Inc. (OTC Bulletin Board:CSBR), a company engaged in the development of advanced preclinical platforms and tumor specific data to enhance the value of oncology drugs, today announced its financial results for the fiscal 2011 first quarter ended July 31, 2010.
China Cord Blood Corporation ("CCBC" or "the Company") (NYSE:CO), China's leading provider of cord blood collection, laboratory testing, hematopoietic stem cell processing, and stem cell storage services, today announced its intention to conduct a share exchange with all existing warrant holders, in which the Company will offer to exchange one ordinary share for every eight warrants.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it will host an Investor Event at the NASDAQ MarketSite, Times Square, New York City at 9:00 a m. ET on Monday, September 20th, 2010.
Cyberonics, Inc. (Nasdaq:CYBX) today announced that it will present at two conferences this month.
CytoGenix, Inc. (Pink sheets: CYGX) today announced that Cy Stein, MD, PhD has been appointed as Chairman of the CYGX Board of Directors replacing Randy Mos ley. Dr. Stein has been on the CytoGenix Board for 7 years and has served as Chairman of the CytoGenix Scientific Advisory Board.
DATATRAK International, Inc. (OTCQX: DATA), a technology and services company focused on global eClinical solutions for the clinical trials industry, announced today that Zacks Investment Research (Zacks) has initiated coverage on the Company, effective September 13, 2010.
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced the U.S. and European launches of its Carpentier-Edwards PERIMOUNT Magna Mitral Ease valve, designed to enhance implantation in the challenging mitral position.
Forest Laboratories, Inc. (NYSE: FRX) today announced that it has filed a response to the U.S. Food & Drug Administration (FDA) addressing topics raised in the complete response letter regarding the New Drug Application (NDA) for roflumilast.
Genomic Health, Inc. (Nasdaq:GHDX) today announced that members of its management team will present at the following conferences in September: Dean Schorno, senior vice president of Finance, will present at the Stifel Nicolaus Healthcare Conference 2010 on Friday, September 17 at 11:30 a.m. ET in Boston.
CytoGenix, Inc. (Pink sheets: CYGX) today announced the resignation of Mr. Randy Moseley, Chief Financial Officer and Chairman of the Board from all ositions within CytoGenix and the appointment of Steven M. Plumb as the new Chief Financial Officer of CytoGenix.
Incyte Corporation (Nasdaq:INCY) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase III trial for its JAK1 and JAK2 inhibitor, INCB18424 in patients with polycythemia vera (PV), a blood cancer that belongs to a group of diseases known as myeloproliferative neoplasms (MPNs).
Lorus Therapeutics Inc. (TSX:LOR)(OTCBB:LRUSF) a biopharmaceutical company specializing in the discovery and development of pharmaceutical products and technologies for the management of cancer, today announced the publication of a peer-reviewed scientific article describing synthesis and antibacterial activity of novel antimicrobial compounds from Lorus' small molecule program.
Mantra Venture Group Ltd. ('Mantra') (OTCBB: MVTG) (FSE: 5MV) is pleased to announce the signing of a Teaming Agreement with Solid Team LLC of Claremont, California, a U.S. management group.
mPhase Technologies, Inc. (OTCBB: XDSL) today announced that it will be showcasing its Smart NanoBattery technology at the 2010 National SBIR Beyond Phase II Conference & Technology Showcase, September 13 - 17, 2010, San Antonio, Texas.
NeoStem, Inc. (NYSE Amex:NBS), an international biopharmaceutical company with operations in the U.S. and China, announced today that Chief Executive Officer, Robin Smith, M.D., MBA, will present on the Company's latest strategic developments at Rodman & Renshaw's 12th Annual Healthcare Conference at the New York Palace Hotel in New York City on September 13-15, 2010.
PDI, Inc. (Nasdaq:PDII) today announced that Nancy Lurker, the company's chief executive officer, is scheduled to present at the UBS Global Life Sciences Conference at 10:30 am ET on September 20, 2010 at The Grand Hyatt New York.
Protectus Medical Devices, Inc. (OTCQB: PTMD), developer and marketer of innovative safety medical devices, today announced that CEO John S. Salstrom, PhD, will attend the Rodman & Renshaw Global Investment Conference to be held on September 12-15, 2010, at the New York Palace Hotel, in New York, NY.
Medtronic, Inc. (NYSE: MDT) has been named a member company in the North America Dow Jones Sustainability Index (DJSI) and the FTSE4Good Index Series.
Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN) will webcast its presentation at the UBS Global Life Sciences Conference on Monday, September 20, 2010. The presentation is scheduled for 10:00 a.m. Eastern Time.
Response Biomedical Corporation (TSX: RBM, OTCBB: RPBIF) today announced that the Company is taking steps to strategically refocus its resources and has implemented a company-wide cost-cutting initiative.
Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, has expanded its development pipeline with the addition of two novel biologic drug candidates focused on specialty markets.
Soligenix, Inc. (Soligenix or the Company) (OTC Bulletin Board:SNGX), a late-stage biopharmaceutical company, announced today that its President and Chief Executive Officer Christopher J. Schaber, Ph.D. will present a company overview highlighting recent developments at the Rodman & Renshaw 12th Annual Healthcare Conference in New York City.
Stellar Biotechnologies, Inc. (TSX-V: KLH) (PINKSHEETS :SBOTF) is collaborating with Bayer Innovation GmbH (BIG) in the development of biopharmaceuticals. Bayer's personalized idiotype vaccine for the treatment of Non-Hodgkin's-Lymphoma (NHL) is currently in Phase I clinical trials, and the cooperation is related to the development of a personalized Non-Hodgkin's-Lymphoma vaccine.
Theravance, Inc. (NASDAQ: THRX) today announced that data from the RELOVAIR program will be presented by GlaxoSmithKline (GSK) at the European Respiratory Society (ERS) Annual Congress, September 18-22, 2010 in Barcelona, Spain.
Transgenomic, Inc. (OTC Bulletin Board:TBIO) today announced that it completed the requirements for CE IVD labeling and has significantly expanded distribution of itsSURVEYOR® Scan K-RAS mutation detection kit throughout most of the European Union.
Trius Therapeutics, Inc. (Nasdaq:TSRX) announced today that Jeffrey Stein, Ph.D., President and Chief Executive Officer of Trius Therapeutics, will provide a corporate presentation to investors attending the Stifel Nicolaus Healthcare Conference on Wednesday, September 15 at 8:35 a.m. ET at the Four Seasons Hotel in Boston, MA.
Universal Detection Technology (OTCBB: UNDT), a developer of early-warning monitoring technologies to protect people from bioterrorism and other infectious health threats, announced today that it has expanded its product catalogue to include a consumer-ready device that detects Francisella tularensis, the bacteria responsible for Tularemia infection.
WellTek, Inc. (OTCBB: WTKN), a global health, fitness and wellness company, is pleased to provide its latest shareholder update, which includes company news and industry related updates.
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