Monthly Archives: July 2012

Ampio Contracts with Syngene to Manufacture Zertane-ED™, its Recently Patented Combination Drug to Treat both …

Posted: Published on July 2nd, 2012

GREENWOOD VILLAGE, Colo., July 2, 2012 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (AMPE), a biopharmaceutical company conducting clinical trials on its three lead drugs (Ampion, Optina & Zertane), licensing distribution of these drugs and developing additional new drugs, today announced that it is proceeding with the development plan for a combination product to treat both premature ejaculation (PE) and erectile dysfunction (ED). The positive pre-IND meeting in June with the FDA gave the company clear guidance for the two concurrent pivotal trials necessary for approval of Zertane to treat PE in the USA. (Logo: http://photos.prnewswire.com/prnh/20120516/MM09116LOGO) Vaughan Clift, MD, Ampio's Chief Regulatory Officer, noted "Contrary to rumors that the FDA did not recognize PE as a treatable ailment, the FDA has expressly adopted the definition of PE as a disease condition, using the definition of Premature Ejaculation provided by the International Society for Sexual Medicine (ISSM) Ad Hoc Committee (i.e., premature ejaculation is characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy.*) This definition fully … Continue reading

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Ampio signs deal with Biocon unit on sexual dysfunction drug

Posted: Published on July 2nd, 2012

REUTERS - Ampio Pharmaceuticals Inc (NAQ:AMPE - News) signed a deal with Syngene, a unit of Bangalore-based Biocon Ltd (NSI:BIOCON.NS - News), to produce its experimental drug for premature ejaculation and erectile dysfunction, sending its shares up 23 percent. The combination drug, Zertane-ED, would be made by Syngene, Ampio said. Ampio's Korea-based partner Daewoong Co Ltd will finance and conduct late-stage studies in South Korea. "We will be working with Daewoong to get the study approved by the U.S. Food and Drug Administration and in South Korea, but there is no specific timeline yet," a company spokesman told Reuters. The drug would combine Ampio's experimental drug Zertane, which is being tested in a late-stage trial to treat premature ejaculation, with an erectile dysfunction drug similar to Pfizer Inc's (PFE.N) blockbuster medicine Viagra. There are currently no approved drugs in the United States to treat premature ejaculation and Ampio estimates up to 30 percent of males treated for premature ejaculation also suffer from erectile dysfunction. The biopharmaceutical company is also developing three other products to treat inflammation and eye damage due to diabetes. Shares of the company were up 11 percent at $5.68 on Monday on the Nasdaq, after soaring to … Continue reading

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Why Cell Phones and Driving Don’t Mix

Posted: Published on July 2nd, 2012

Drivers beware: The brain can't multitask as well as you might think. In every issue of WebMD the Magazine, we ask experts to answer readers' questions about a wide range of topics, including questions about what's true and not true in the field of medicine. For our July/August 2012 issue, we interviewed a University of Utah researcher about the danger of using a phone behind the wheel. Q: I've read that driving while talking on a cell phone is as bad as driving drunk. Is that true? EMDR: Eye Movement Desensitization and Reprocessing Eye movement desensitization and reprocessing (EMDR) is a fairly new, nontraditional type of psychotherapy. It's growing in popularity, particularly for treating post-traumatic stress disorder (PTSD). PTSD often occurs after experiences such as military combat, physical assault, rape, or car accidents. Although research continues, EMDR remains controversial among some health care professionals. At first glance, EMDR appears to approach psychological issues in an unusual way. It does not rely on... Read the EMDR: Eye Movement Desensitization and Reprocessing article > > A: Many people can't imagine not chatting on the phone while driving. But the stories you've heard are TRUE. Cell phone use impairs driving just as much … Continue reading

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Why Cell Phones and Driving Don't Mix

Posted: Published on July 2nd, 2012

Drivers beware: The brain can't multitask as well as you might think. In every issue of WebMD the Magazine, we ask experts to answer readers' questions about a wide range of topics, including questions about what's true and not true in the field of medicine. For our July/August 2012 issue, we interviewed a University of Utah researcher about the danger of using a phone behind the wheel. Q: I've read that driving while talking on a cell phone is as bad as driving drunk. Is that true? EMDR: Eye Movement Desensitization and Reprocessing Eye movement desensitization and reprocessing (EMDR) is a fairly new, nontraditional type of psychotherapy. It's growing in popularity, particularly for treating post-traumatic stress disorder (PTSD). PTSD often occurs after experiences such as military combat, physical assault, rape, or car accidents. Although research continues, EMDR remains controversial among some health care professionals. At first glance, EMDR appears to approach psychological issues in an unusual way. It does not rely on... Read the EMDR: Eye Movement Desensitization and Reprocessing article > > A: Many people can't imagine not chatting on the phone while driving. But the stories you've heard are TRUE. Cell phone use impairs driving just as much … Continue reading

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ACT Announces Second Patient with Stargardt’s Disease Treated in EU Clinical Trial

Posted: Published on July 2nd, 2012

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the second patient in its Phase 1/2 clinical trial for Stargardts macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The surgery was performed on Friday, June 29 at Moorfields Eye Hospital in London, the same site as the first patient treatment in January, by a team of surgeons led by Professor James Bainbridge, consultant surgeon at Moorfields and Chair of Retinal Studies at University College London. The procedure was successfully performed without any complications. ACT and Moorfields Eye Hospital recently received clearance from the Data and Safety Monitoring Board (DSMB) to treat the final two patients in the first cohort of this clinical trial. We are very pleased to continue our forward momentum with both our U.S. trials and our European trial, commented Gary Rabin, chairman and CEO. It was less than a month ago that we received DSMB approval to treat the second and third patients in our E.U. trial, and it is very gratifying to have already completed dosing of the second. It is a pleasure to be … Continue reading

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You Can’t Keep a Good Cell Down

Posted: Published on July 2nd, 2012

--Study shows vast majority of cells close to death after toxin exposure can survive and thrive Newswise The vast majority of cells that appear to be on a one-way track to death after exposure to toxins can bounce back completely after those toxins are removed, Johns Hopkins scientists report in a new study. The finding, published in the June 15 issue of Molecular Biology of the Cell, is not only a testament to the indomitable cellular spirit, but could also offer some practical insight on how to save dying tissues after heart attacks or strokes as well as prevent cancer in cells transiently exposed to toxins. For decades, researchers have known that cells undergo a type of programmed death called apoptosis, says study leader Denise Montell, Ph.D., a professor in the Department of Biological Chemistry at the Johns Hopkins University School of Medicine. Apoptosis can be both positive and negative, she adds. For example, cell death is absolutely necessary to sculpt fingers from paddle-shaped hands during development and to kill off rogue cells that could be the start of cancerous tumors. However, it also kills cells in excess after traumatic events such as a heart attack or stroke, or in … Continue reading

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You Can't Keep a Good Cell Down

Posted: Published on July 2nd, 2012

--Study shows vast majority of cells close to death after toxin exposure can survive and thrive Newswise The vast majority of cells that appear to be on a one-way track to death after exposure to toxins can bounce back completely after those toxins are removed, Johns Hopkins scientists report in a new study. The finding, published in the June 15 issue of Molecular Biology of the Cell, is not only a testament to the indomitable cellular spirit, but could also offer some practical insight on how to save dying tissues after heart attacks or strokes as well as prevent cancer in cells transiently exposed to toxins. For decades, researchers have known that cells undergo a type of programmed death called apoptosis, says study leader Denise Montell, Ph.D., a professor in the Department of Biological Chemistry at the Johns Hopkins University School of Medicine. Apoptosis can be both positive and negative, she adds. For example, cell death is absolutely necessary to sculpt fingers from paddle-shaped hands during development and to kill off rogue cells that could be the start of cancerous tumors. However, it also kills cells in excess after traumatic events such as a heart attack or stroke, or in … Continue reading

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You can’t keep a good cell down: Vast majority of cells close to death after toxin exposure can survive and thrive

Posted: Published on July 2nd, 2012

ScienceDaily (July 2, 2012) The vast majority of cells that appear to be on a one-way track to death after exposure to toxins can bounce back completely after those toxins are removed, Johns Hopkins scientists report in a new study. The finding, published in the June 15 issue of Molecular Biology of the Cell, is not only a testament to the indomitable cellular spirit, but could also offer some practical insight on how to save dying tissues after heart attacks or strokes as well as prevent cancer in cells transiently exposed to toxins. For decades, researchers have known that cells undergo a type of programmed death called apoptosis, says study leader Denise Montell, Ph.D., a professor in the Department of Biological Chemistry at the Johns Hopkins University School of Medicine. Apoptosis can be both positive and negative, she adds. For example, cell death is absolutely necessary to sculpt fingers from paddle-shaped hands during development and to kill off rogue cells that could be the start of cancerous tumors. However, it also kills cells in excess after traumatic events such as a heart attack or stroke, or in degenerative diseases such as Alzheimer's. When apoptosis was first described long ago, Montell … Continue reading

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You can't keep a good cell down: Vast majority of cells close to death after toxin exposure can survive and thrive

Posted: Published on July 2nd, 2012

ScienceDaily (July 2, 2012) The vast majority of cells that appear to be on a one-way track to death after exposure to toxins can bounce back completely after those toxins are removed, Johns Hopkins scientists report in a new study. The finding, published in the June 15 issue of Molecular Biology of the Cell, is not only a testament to the indomitable cellular spirit, but could also offer some practical insight on how to save dying tissues after heart attacks or strokes as well as prevent cancer in cells transiently exposed to toxins. For decades, researchers have known that cells undergo a type of programmed death called apoptosis, says study leader Denise Montell, Ph.D., a professor in the Department of Biological Chemistry at the Johns Hopkins University School of Medicine. Apoptosis can be both positive and negative, she adds. For example, cell death is absolutely necessary to sculpt fingers from paddle-shaped hands during development and to kill off rogue cells that could be the start of cancerous tumors. However, it also kills cells in excess after traumatic events such as a heart attack or stroke, or in degenerative diseases such as Alzheimer's. When apoptosis was first described long ago, Montell … Continue reading

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Researchers Block Pathway to Cancer Cell Replication

Posted: Published on July 2nd, 2012

NOTCH1 Signaling Promotes T-Cell Acute Lymphoblastic Leukemia-Initiating Cell Regeneration Newswise Research suggests that patients with leukemia sometimes relapse because standard chemotherapy fails to kill the self-renewing leukemia initiating cells, often referred to as cancer stem cells. In such cancers, the cells lie dormant for a time, only to later begin cloning, resulting in a return and metastasis of the disease. One such type of cancer is called pediatric T cell acute lymphoblastic leukemia, or T-ALL, often found in children, who have few treatment options beyond chemotherapy. A team of researchers led by Catriona H. M. Jamieson, MD, PhD, associate professor of medicine at the University of California, San Diego School of Medicine and Director of Stem Cell Research at UC San Diego Moores Cancer Center studied these cells in mouse models that had been transplanted with human leukemia cells. They discovered that the leukemia initiating cells which clone, or replicate, themselves most robustly activate the NOTCH1 pathway, usually in the context of a mutation. Earlier studies showed that as many as half of patients with T-ALL have mutations in the NOTCH1 pathway an evolutionarily conserved developmental pathway used during differentiation of many cell and tissue types. The new study shows … Continue reading

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