|Key data left out of Alzheimer's study. Second patient treated in Geron stem cell trial.|
|By BioMedReports.com Staff|
|Tuesday, 10 May 2011 19:30|
Key data left out of Alzheimer's study - A U.S. consumer group alleged on Tuesday that researchers with ties to Eli Lilly and Co (NYSE:LLY) withheld important information from a medical journal in their study of an imaging drug for Alzheimer's disease. It was reported that the study authors excluded data on how accurately the scans were interpreted from one physician to the next.
"By withholding important information, the authors misled the journal and its readers to believe that this test for identifying brain abnormalities was more reliable than it actually is," Dr. Michael Carome, deputy director of Public Citizen's Health Research Group, wrote.
In a letter published in the Journal of the American Medical Association, Public Citizen criticized a Jan. 19 study that assessed the effectiveness of brain scans using Lilly's Amyvid, an experimental dye to detect brain abnormalities. "Given what is known about Alzheimer's disease and the lack of effective treatments, any proposed test for diagnosing this disease must be proven to be highly accurate in large, rigorously conducted studies before it is approved by the FDA for marketing," Carome said.
Lilly strongly disputes their claims, calling them "inaccurate." "We worked with the FDA to identify and specify all endpoints for the Amyvid Phase III study," the company said in a statement.
Lilly said all of the endpoints in the study were met, and they were "disclosed appropriately.
Second patient treated in Geron stem cell trial. - Doctors inject second patient with spinal cord injury. U.S. doctors have begun treating a second patient injected with human embryonic stem cells in the spine as part of a landmark Geron Corp (NASDAQ:GERN) clinical trial testing the cells in spinal cord injuries. The unidentified patient will undergo a progressive course of rehabilitation at the Rehabilitation Institute of Chicago after receiving an injection of stem cells at Northwestern Memorial Hospital.
Geron's stem cells come from human embryos left over from fertility treatments. They have been manipulated to become precursors to certain types of nerve cells. They hope the cells regenerate once it reaches the damaged nerves in the cord. The Phase I trial will not be aiming to cure patients but to establish that the cells are safe to use. But the team will also look to see if the stem cells improve patients' control or sensation in the trunk or legs. Per the guidelines of the trial, the patients must have very recent injuries.
The first person to get an injection of the cells more than six months ago has not had any serious side effects. In animal studies, stem cells being used in the study have shown they can restore the protective myelin coating to damaged nerve cells that have lost their ability to conduct electrical impulses. The stem cells also have shown nerve-growth stimulating properties leading to restoration of function in animals with acute spinal cord injury. Geron's shares gained 11 cents, or 2.25%, to close at $5 on Tuesday.
AcelRx Pharmaceuticals, Inc., (NASDAQ:ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, announced that the opposition period for a patent granted by the European Patent Office expired on April 21 and to date there is no indication that the patent has been opposed.
AdCare Health Systems, Inc. (NYSE Amex: ADK), a leading skilled nursing and assisted living provider, reported unaudited financial results for the first quarter ended March 31, 2011.
Allied Healthcare International Inc. (NASDAQ: AHCI), a leading homecare provider of health and social care in the United Kingdom and Ireland, today issued financial results for its fiscal 2011 second quarter ended March 31, 2011.
BioSpecifics Technologies Corp. (NASDAQ:BSTC), a biopharmaceutical company developing first in class collagenase-based products, today announced its financial results for the first quarter ended March 31, 2011 and provided a corporate update.
China Biologic Products, Inc. (NASDAQ:CBPO) ("China Biologic" or the "Company"), one of the leading plasma-based biopharmaceutical companies in the People's Republic of China ("PRC"), today corrected two administrative errors in its earnings release issued on May 9, 2011.
Global General Technologies Inc. (PINK SHEETS:GLGT) (www.glgt-corporate.com) and its main subsidiary, AB (Wuhan) Biotech Co. Ltd., have invested in a joint venture with three other parties in Wuhan, China.
eHealthInsurance (NASDAQ: EHTH), the leading online source of health insurance for individuals, families and small businesses, published tips for small business owners who may not be taking full advantage of benefits provided by health care reform legislation.
First China Pharmaceutical Group, Inc. (OTCBB: FCPG) ("First China" or the "Company") is very pleased to announce and welcome the appointment, effective immediately, of Mr. Jack Zwick, CPA to the Company's Board of Directors and to the position of audit committee chairman.
FONAR Corporation (NASDAQ: FONR), today announced its earnings for the third quarter of fiscal 2011, ended March 31, 2011.
Given Imaging Ltd (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced that new studies confirmed the benefit of using PillCam SB earlier in the diagnostic algorithm to accelerate the diagnosis of patients who present with obscure GI bleeding.
HearAtLast Holdings, Inc. (PINKSHEETS: HRAL) announced today that it has partnered with VitaSound Audio to develop business opportunities in the growing market for hearing products in Canada.
Interleukin Genetics, Inc. (OTCQB: ILIU) and Metagenics, Inc. today announced that they have entered into a research collaboration to identify predictive biomarkers combinations for use with Metagenics Compound Meta-060, which is a proprietary and patented formulation of tetrahydro iso-alpha acids derived from hops, in development for weight management.
Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today reported results for the first quarter ended March 31, 2011.
Life Technologies Corporation (NASDAQ:LIFE), today announced that its 7500 Fast Dx Real-Time PCR Instrument and 3500 Dx Series Genetic Analyzer are now available platforms suitable for in vitro diagnostics (IVD) use in Japan.
Medical Marijuana Inc (PINKSHEETS: MJNA) today received additional assets transferred by CannaBANK™. These assets include CannaBANK's interest in a Riverside County facility containing 10,000 sq feet of facility space.
Oncolytics Biotech Inc. (TSX:ONC, NASDAQ: ONCY) announced today that the Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, U.S. National Cancer Institute (NCI), which is part of the National Institutes of Health, has agreed to sponsor a Phase I study of REOLYSIN® alone in patients with relapsed multiple myeloma.
Optimer Pharmaceuticals, Inc. (NASDAQ:OPTR) today announced the presentation of two abstracts at the 21st European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) conference in Milan, Italy highlighting additional analyses of the Phase 3 data of DIFICID™ (fidaxomicin) for the treatment of Clostridium difficile infection (CDI).
Pegasystems Inc. (NASDAQ: PEGA) today announced financial results for the first quarter ended March 31, 2011. GAAP revenue for the first quarter of 2011 increased 36% to $102.4 million compared to the first quarter of 2010. Non-GAAP revenue for the first quarter of 2011 increased 38% to $103.9 million compared to the first quarter of 2010.
PROLOR Biotech, Inc. (NYSE Amex:PBTH), a clinical stage company developing next generation biobetter therapeutic proteins, today announced that company management will give a corporate presentation at the 12th Annual Oppenheimer Israeli Conference, to be held at the David Intercontinental Hotel in Tel Aviv, Israel.
Savanna East Africa, Inc. (PINKSHEETS: NVAE) (OTCQB: NVAE) today announced that the Company has scheduled an Update Webcast from CEO Randell Torno for release next Tuesday, May 17th.
Stellar Biotechnologies, Inc. (PINKSHEETS: SBOTF) (TSX-V: KLH) announces the completion of a pre-Investigational Device Exemption (pre-IDE) meeting with the U.S. Food and Drug Administration's (FDA) Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health to discuss Stellar's proposed anti-KLH assay currently in development.
WuXi PharmaTech (Cayman) Inc. (NYSE:WX), a leading research and development outsourcing company serving the pharmaceutical, biotechnology, and medical device industries, with operations in China and the United States, today announced its financial results for first-quarter 2011
Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced that several new studies recommend the value of using ManoScan™ high resolution manometry to definitively diagnose and treat gastrointestinal motility disorders.