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| Adeona Pharma announced that the Board of Directors has taken several actions to prioritize the Company's focus on its recent entry into the emerging field of synthetic biology (AEN) 1.19 : As previously announced on November 22, 2011, the Company and Intrexon entered into a worldwide exclusive channel collaboration for the development and commercialization of a synthetic DNA-based therapy to treat pulmonary arterial hypertension. A proposed name change of the Company to Synthetic Biologic to better reflect its new mission and primary business, subject to the filing of necessary regulatory documents and stockholder approval. The recruitment and appointment of John Monahan as the Company's Senior Vice President of Research & Development. -- Name Change Reflects Primary Focus on Synthetic DNA Therapeutics Business -- -- Recruitment of Gene Medicine Industry Pioneer Strengthens Senior Management Team -- -- Satellite Office in Northern Virginia Facilitates Collaborations -- ...... ANN ARBOR, Mich. , Dec. 21, 2011 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), (the "Company") announced today that the Board of Directors has taken several actions to prioritize the Company's focus on its recent entry into the emerging field of synthetic biology. As previously announced on November 22, 2011 , the Company and Intrexon Corporation ("Intrexon") entered into a worldwide exclusive channel collaboration for the development and commercialization of a synthetic DNA-based therapy to treat pulmonary arterial hypertension (PAH). Today's announcements are the result of the Company's new primary focus and include the following changes approved by the Board: •A proposed name change of the Company to Synthetic Biologics, Inc., to better reflect its new mission and primary business, subject to the filing of necessary regulatory documents and stockholder approval. •The recruitment and appointment of John Monahan , Ph.D., as the Company's Senior Vice President of Research & Development. Dr. Monahan is an experienced CEO-level executive of biotech companies focused on gene medicine and pharmaceutical companies with biotechnology research departments. He has created and directed a number of successful teams that excelled in these companies. Most recently, Dr. Monahan founded and built Avigen, Inc., a biotech company that pioneered and led the development of gene medicines based on AAV vectors, now an industry standard. Over a 12 year period as CEO of Avigen, he took the company public through its IPO and raised over $235 million . He led the company through a number of gene medicine Investigational New Drug (IND) applications and exited the company leaving a cash position of $100 million and a new management team that he grew over the years. Prior to founding Avigen, Dr. Monahan served as Vice President - Research and Development at Somatix, another pioneering gene medicine company, Director, Molecular & Cell Biology at Triton Biosciences (since merged with Berlex Laboratories), Research Group Chief, Department of Molecular Genetics at Hoffmann-LaRoche, Inc. and Adjunct Assistant Professor, Department of Cell Biology at New York University . Dr. Monahan was also a pioneer in gene cloning and holds the distinction as the second person in the world to clone a gene mRNA sequence (Chick Ovalbumin). •The Company has established a satellite office in Northern Virginia , to further facilitate the Company's focus on synthetic DNA-based therapeutics, the collaboration between the employees of the Company and Intrexon, and the relationship with the Company's regulatory consultants. Commenting on today's announcements, the Company's Chairman, Jeffrey Riley stated, "These changes should better enable the Company to concentrate its efforts and build core competencies in the emerging field of synthetic biology and DNA-based human therapeutics, areas in their infancy with extraordinary potential." "By overcoming many of the technical obstacles that limited traditional gene medicine approaches, synthetic DNA-based biologics may allow us to optimize the delivery of therapeutic proteins in a safe, controlled and localized fashion never before possible. In turn, this may provide physicians the ability to radically transform the way in which many serious diseases can be treated. I am pleased to be joining the Company, and to be a part of this innovative new effort and area," stated John Monahan , Ph.D., the Company's Senior Vice President of Research & Development. James S. Kuo , M.D., M.B.A., Chief Executive Officer of the Company stated, "I am grateful to the Board of Directors for accepting and backing the new vision for the future direction of the Company. This represents an exciting time for the Company and one that I expect will be a great opportunity for our shareholders." In connection with the proposed name change, the Company has filed a preliminary proxy statement with the Securities and Exchange Commission, which following approval will permit the Company to print and mail proxy materials for the scheduled Special Meeting of Stockholders to be held on February 15, 2012 to vote on the proposed name change. The record date for stockholders entitled to vote at this Special Meeting has been set as December 19, 2011 . The Company's ongoing and planned clinical trials of Trimesta™ (estriol) for multiple sclerosis are expected to continue and the Company's planned clinical trial of AEN-100 (modified release zinc) for amyotrophic lateral sclerosis (ALS) is also expected to continue. In addition, the Company intends to seek marketing partners for its marketable zinc-based products reaZin™ and wellZin™. About Adeona Pharmaceuticals, Inc. Adeona is a biotechnology company focused on the development of synthetic DNA-based therapeutics and innovative disease-modifying medicines for serious illnesses. Adeona is developing, or has partnered the development of, product candidates to treat pulmonary arterial hypertension, relapses in multiple sclerosis, cognitive dysfunction in multiple sclerosis, fibromyalgia and amyotrophic lateral sclerosis (ALS). For more information, please visit Adeona's website at www.adeonapharma.com Synthetic Biologics is a trademark of Adeona Pharmaceuticals, Inc.
__________________ FYI when I post I do not link charts as you and I have diff settings and we both know charts can turn on a moments notice. Please do your own DD as I can only be held responsible if/when you make $$$$$$! |
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As previously stated this is one of fav pharma stocks,,,the DD is up to you. Adeona Announces Initiation of Phase II Clinical Trial of Trimesta™ for Cognitive Dysfunction in Multiple Sclerosis Press Release: Adeona Pharmaceuticals, Inc. – Thu, Jan 19, 2012 6:30 AM EST ANN ARBOR, Mich., Jan. 19, 2012 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of synthetic DNA-based therapeutics and innovative disease-modifying medicines for serious illnesses, announced today the initiation of the Phase II clinical trial of Trimesta™ (oral estriol) for the treatment of cognitive dysfunction in multiple sclerosis (MS). This clinical trial is intended to enroll 64 relapsing-remitting or secondary-progressive female MS patients at University of California, Los Angeles (UCLA) and is being conducted at by Principal Investigator, Rhonda Voskuhl, M.D., Director, UCLA Multiple Sclerosis Program, Department of Neurology. There is currently no approved therapy for the treatment of cognitive dysfunction in MS. "We are very excited to initiate patient enrollment in this novel clinical trial of Trimesta in which the primary endpoint is improvement in cognition. Statistics show that 50-65 percent of patients affected by MS will develop disabilities due to a reduction in their cognitive processing speed. Despite the fact that cognitive dysfunction is a primary source of work related disability in MS, there remains no treatment to target this disability," said Dr. Voskuhl, Principal Investigator. "The goal of this trial is to address this unmet need for MS patients, potentially improving a person's mental sharpness and ability to continue working." This randomized, double-blind, placebo-controlled Phase II clinical trial is based on findings from a previously completed 10-patient, single-agent, crossover Phase I/II clinical trial conducted by Dr. Voskuhl and colleagues at UCLA. The results from the Phase I/II trial demonstrated a statistically significant 14% improvement from baseline in Paced Auditory Serial Addition Test (PASAT) cognitive testing scores in relapsing-remitting MS patients after six months of Trimesta™ therapy (p = 0.04).[i] The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability and is widely used in MS to measure cognitive function. Estriol has also been shown to have neuroprotective benefits in animal models of MS, a property not generally shared by currently approved MS therapies.[ii] The new Phase II clinical trial is a randomized, double-blind, placebo-controlled trial intended to enroll 64 relapsing-remitting or secondary-progressive female MS patients. Subjects will be equally randomized to receive either once-daily Trimesta™ (oral estriol) or matching placebo. The primary outcome measure is the average change in PASAT scores at 12 months between each group. Secondary outcome measures include relapse rates (the primary endpoint of the ongoing Phase II clinical trial of Trimesta™ for relapsing-remitting MS), whole brain atrophy determined by MRI and safety. Charitable organizations have pledged to financially support a majority of the new MS clinical trial. Detailed information regarding this clinical trial, including contact information for the clinical site, is available at http://www.clinicaltrials.gov/ct2/show/NCT01466114. In addition to the clinical trial of Trimesta for cognitive dysfunction in MS, Trimesta™ is also the subject of a separate ongoing 15-center Phase II, randomized, double-blind, placebo-controlled clinical trial seeking to demonstrate Trimesta's ability to reduce relapse rates in women with the relapsing-remitting form of MS. With over $8 million in grant funding awarded to date, this separate ongoing Trimesta™ clinical trial should be funded to its completion. Additional information regarding the relapsing-remitting multiple sclerosis clinical trial is available at http://www.clinicaltrials.gov/ct2/show/NCT00451204. "While our Board of Directors has strategically implemented several actions to prioritize our focus on the emerging field of synthetic biologics, our continued commitment to this important new MS clinical trial, having substantial external funding, is consistent with our mission of maintaining and building value for our shareholders," stated Jeffrey Riley, Adeona's Chairman of the Board. About Trimesta™ (oral estriol) Trimesta™ is Adeona's proprietary drug candidate for the treatment of relapsing-remitting MS and for cognitive dysfunction in MS, both in female patients. Estriol has been approved and marketed for more than 40 years throughout Europe and Asia for the treatment of post-menopausal symptoms. It has never been approved in the United States by the Food and Drug Administration (FDA) for any indication. About Cognitive Dysfunction in Multiple Sclerosis According to the National Multiple Sclerosis Society and the Multiple Sclerosis Society of Canada publication, Hold that Thought! Cognition and MS, it is fairly common for people with multiple sclerosis to complain of problems remembering things, finding the right words, concentrating on a task or something they are reading, or following a conversation. These are all cognitive symptoms of multiple sclerosis. Fifty to sixty-five percent of those affected by multiple sclerosis have cognitive dysfunction. Despite the fact that most symptoms are mild to moderate, they can have a significant impact on a person's ability to normally function. The overall cognitive dysfunction can be described as a reduction in mental "sharpness." The major areas of cognition that can be dysfunctional include what are termed complex attention and executive functions. Complex attention involves multitasking, the speed with which information can be processed, learning and memory, and perceptual skills; executive functions include problem solving, organizational skills, the ability to plan, and word finding. Just as the nature, frequency, and severity of multiple sclerosis-related physical problems can widely vary, not all people with multiple sclerosis will display these cognitive issues, and no two people will experience exactly the same types or severity of problems
__________________ FYI when I post I do not link charts as you and I have diff settings and we both know charts can turn on a moments notice. Please do your own DD as I can only be held responsible if/when you make $$$$$$! |
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Oh my it just keeps getting better and better! Adeona Pharmaceuticals (AEN): AEN is a development-stage biotech focused on the development of synthetic DNA-based therapeutics and innovative disease-modifying medicine for serious illnesses, with current drugs under clinical development targeting pulmonary arterial hypertension (PAH), multiple sclerosis, fibromyalgia and amyotrophic lateral sclerosis (ALS). On Thursday, New York-based healthcare-focused hedge fund Empery Asset Management filed SEC Form SC 13G indicating that it holds no shares and warrants to purchase 0.71 million shares, a decrease from the 1.43 million shares and warrants to purchase 0.71 million shares that they reported in a prior SC 13G filing in January of last year. AEN shares have been in a strong rally mode recently, up from 50 cents in mid-November to current prices in the $1.80s after rising as high as $2.30s earlier this week, as the company has released a spate of positive news starting with the mid-November announcement of a collaboration with Intrexon for Synthetic DNA-based therapy for PAH, and then positive clinical study results for its oral zinc compound in ALS, announced by its collaborator, the PNA Center for Neurological Research, in late-November.
__________________ FYI when I post I do not link charts as you and I have diff settings and we both know charts can turn on a moments notice. Please do your own DD as I can only be held responsible if/when you make $$$$$$! |
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