|ALIMTA Extends Survival in Continuation Maintenance Setting for Specific Lung Cancer Patients; New Research on Anatabine's Beneficial Effect on Alzheimer's|
|By Staff and Wire Reports|
|Wednesday, 17 October 2012 18:40|
Eli Lilly and Company (NYSE: LLY) announced patients may receive ALIMTA® (pemetrexed for injection) as a maintenance therapy following first-line ALIMTA plus cisplatin for locally advanced or metastatic nonsquamous non-small cell lung cancer (NS NSCLC). The FDA approved the label inclusion of Phase III data that demonstrated progression-free and overall survival advantages in the continuation maintenance setting for these patients.
Appropriate patients can now start with ALIMTA plus cisplatin and continue with ALIMTA in the maintenance setting in advanced or metastatic NS NSCLC. ALIMTA is indicated for the maintenance treatment of patients with locally advanced or metastatic NS NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ALIMTA is not indicated for patients with squamous-cell NSCLC. Myelosuppression is usually the dose-limiting toxicity with ALIMTA therapy.
"Continuation maintenance" involves continuing one of the same medicines prescribed in first-line treatment as maintenance therapy, in an effort to extend survival. It is the most recent addition to a new paradigm of maintenance treatment for advanced nonsquamous non-small cell lung cancer. Prior to the use of maintenance treatment, physicians typically treated a patient with four to six cycles of chemotherapy and then waited until the disease returned or worsened before resuming treatment.
"The approval provides patients and physicians with a new regimen that has demonstrated an improvement in overall survival. A survival benefit was previously established for ALIMTA for the first-line treatment of advanced nonsquamous non-small cell lung cancer in combination with cisplatin, and now as a single-agent for continuation maintenance treatment," said Richard Gaynor, M.D., vice president, product development and medical affairs for Lilly Oncology. "This is the first study to show a survival advantage for continuation maintenance, and it reinforces the role of ALIMTA in treating patients with advanced nonsquamous NSCLC."
In October 2011, the European Commission granted approval for the use of ALIMTA as a single agent for continuation maintenance in patients with advanced NS NSCLC based on progression-free survival and preliminary overall survival. On September 21, 2012, theCommittee for Medicinal Products for Human Use (CHMP) in the European Union issued a positive opinion for a label update for ALIMTA in the continuation maintenance setting for certain patients with advanced nonsquamous non-small cell lung cancer after initial treatment with ALIMTA plus cisplatin.
The FDA and European Commission approvals were based on results from PARAMOUNT, a global, multicenter, double-blind Phase III trial, the final results of which were shared in an oral presentation at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Ill. on June 4, 2012. PARAMOUNT was the first study to evaluate the first-line use of ALIMTA plus cisplatin therapy followed immediately by the use of ALIMTA as a single-agent in the continuation maintenance setting.
Star Scientific (NASDAQ: STSI) through its wholly owned subsidiary, Rock Creek Pharmaceuticals Inc., reports that scientists from its research partner, the Roskamp Institute, presented research this week showing that anatabine supplementation reduces the pathology and signs in an animal model of Alzheimer's disease. The findings were presented in New Orleans, Louisiana, at Neuroscience 2012, the 42nd annual meeting of the Society for Neuroscience, as part of a series of presentations by researchers from the Roskamp Institute on supplementation with anatabine, the active ingredient in the Company's Anatabloc® dietary supplement. Neuroscience 2012 is the world's largest and most prestigious scientific meeting dedicated to brain and neurological science, with more than 32,000 neuroscientists from around the world gathering to observe and participate in presentations relating to more than 16,000 new discoveries in science and health.
Megha Verma of the Roskamp Institute delivered the poster presentation titled, "Anti-Inflammatory and Amyloid Beta Lowering Properties of Anatabine in a Transgenic Mouse Model of Alzheimer's Disease", in which scientists reported that anatabine treated Alzheimer's mice retained their memory and learning compared to the untreated Alzheimer's mice. Dr. Michael Mullan, President and CEO of the Roskamp Institute, stated, "In examining how anatabine works, the researchers show that key molecules which govern inflammation were deactivated, and this is important because we know that inflammation both promotes and maintains the deterioration of the brain in Alzheimer's disease."
Last year, the Company reported the publication of the first peer-reviewed article on the in-vitro and in-vivo activity of anatabine in Alzheimer's Disease in the European Journal of Pharmacology (Paris et al. 2011 Sept 19). This week's presentation in New Orleans expands upon that published work and marks the first time the data have been presented at an international scientific convention.
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it will host a teleconference and webcast to provide a general business overview and to discuss its third quarter 2012 financial results on Tuesday, November 6, 2012 at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).
Align Technology, Inc. (NASDAQ: ALGN) today announced that the Company has reached a mutual agreement with Straumann to terminate their distribution agreements for iTero intra-oral scanners in Europe and North America, effective December 31, 2012.
Amarantus BioSciences, Inc. (OTCQB: AMBS), a biotechnology company developing new treatments for brain-related disorders including Parkinson's disease and Traumatic Brain Injuries (TBI) centered on its unique proprietary anti-apoptotic therapeutic protein known as MANF, today announced a Translational Research Grant award from the University of Massachusetts' Pioneer Valley Life Sciences Institute's Center of Excellence in Apoptosis Research (CEAR).
Bioheart, Inc. (OTCQB: BHRT) today announced that they have agreed to extend the license agreement with Airspeed for four separate Bioheart patents.
BioLife Solutions, Inc. (OTCBB: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media for cells and tissues, and contract aseptic media manufacturer, today announced that it will begin marketing and distributing a novel hair graft storage solution additive that has demonstrated it can improve the survival of hair grafts during hair transplantation procedures.
Cempra, Inc. (Nasdaq: CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced that data show continued differentiation of the company's fourth-generation macrolide/fluoroketolide, solithromycin, from currently available macrolides.
CompuMed, Inc. (PINKSHEETS: CMPD) (www.compumed.net) -- a leader in telemedicine services for patient diagnosis and management -- will exhibit at the National Conference of the National Commission on Correctional Health Care (NCCHC).
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that it will host a conference call on Wednesday, October 24, 2012 at 11:00 AM Eastern Time to discuss corporate updates and financial results for the third quarter ended September 30, 2012.
Given Imaging (NASDAQ: GIVN) today announced that in order to maximize growth and enhance shareholder value the Company is currently evaluating a range of strategic options, including preliminary non-binding indications of interest received from a number of parties relating to a possible merger or sale of the Company.
Greengro Technologies, Inc. (PINKSHEETS: GRNH), an eco-friendly green provider of indoor and outdoor agricultural science systems and complementary technologies, is pleased to announce the completion of its upgrade of financial transparency and the continuation of its aggressive growth plans.
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it commenced an offering to sell, subject to market and other conditions, shares of its common stock pursuant to an effective shelf registration statement in an underwritten public offering.
Lpath, Inc. (OTCQB: LPTND), the industry leader in bioactive lipid-targeted therapeutics, has received confirmation that its application to list the company's common stock on the NASDAQ Capital Market has been approved by the NASDAQ Stock Market, a unit of the NASDAQ OMX Group.
Micro Imaging Technology, Inc. (OTCQB: MMTC) announced that it will attend the 7th Annual International Conference for Food Safety and Quality on November 13-14, 2012 in Chicago, Illinois.
Sangamo BioSciences, Inc. (Nasdaq: SGMO) today announced that the company will release its third quarter 2012 financial results on Wednesday, October 24, 2012, after the market closes.
Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced that data from its program with Shire AG (LSE: SHP, NASDAQ: SHPG) to develop a novel ZFP Therapeutic approach to Huntington's disease (HD), an inherited progressive neurodegenerative disease, were presented at the 2012 Annual Meeting of the Society for Neuroscience, which is the world's largest forum for neuroscientists and is being held in New Orleans from October 13-17, 2012.
Star Nutrition, Inc. (PINKSHEETS: STAU), a California-based diversified health and wellness industry firm, has announced the release of the latest addition to its popular Incrediwear line: The TEC-3 arm and calf sleeves.
Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders, today announced it will release results for the third quarter of 2012 on Wednesday, November 7, 2012, before the market opens.
VIVUS, Inc. (NASDAQ: VVUS) today announced that it has submitted an amendment to the Risk Evaluation and Mitigation Strategy (REMS) for Qsymia™.