GREENWOOD VILLAGE, Colo., May 31, 2011 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE)("Ampio") announced today that it received ethics board approval for a Phase 1B clinical trial in Australia of its biologic anti-inflammatory agent, Ampion™. Patients are now being recruited for first dosing in the three arm, placebo controlled, 60 patient trial designed to demonstrate efficacy in the treatment of osteoarthritis of the knee as well as to confirm patient safety and tolerance.
The present "standard of care" treatment for this condition is the injection of a short acting local anesthetic agent combined with a long acting steroid into and around the joint. In the Ampion trial the mitigation of pain and loss of function caused by osteoarthritis will be assessed at intervals from the time of injection. Patients will be evaluated for 72 hours and various parameters will be followed to demonstrate that Ampion™ is well tolerated and provides pain relief through decreased inflammation as well as demonstrated improvement in the range of motion of the knee.
Dr. David Bar-Or, MD, Ampio's Chief Scientific Officer, noted, "We discovered this molecule in patients with severe head injury who experienced decreased immune/inflammatory function. The molecule is produced in the body from our own serum albumin and is the most abundant protein in human plasma. We realized from our studies in human tissue that this molecule is an integral part of the innate control of inflammation. We know of many molecules made by our body that increase inflammation but of very few that decrease it. We are hopeful that Ampion™, with few or no side effects, will provide real relief for patients suffering from chronic inflammatory conditions," stated Dr. Bar-Or.
Ampio CEO Don Wingerter noted, "Since Ampion™ is a biologic product made by our bodies, we believe there is the probability of markedly greater safety than steroids or other anti-inflammatory drugs. We anticipate this clinical trial will demonstrate sufficient proof of safety and efficacy to allow longer term studies in which relief may be obtained without prolonged use of steroids, especially when knee replacement is not an option. We are hopeful this drug will provide clinical utility and safety greater than products now selling in the multi-billion dollar market for anti-inflammatories."
Vaughan Clift, MD, Ampio's Chief Regulatory Officer added, "We are very grateful to our Australian Principal Investigators, Dr. Peter Lewis and Dr. Andrew Comley, who helped in the design of the trial and approval process and whose leadership has resulted in encouraging support from local General Practitioners who are also identifying and referring patients into this AIK (Ampion in knee) trial. We expect the trial results will form the basis for submissions to various regulatory agencies to conduct Phase II/III studies of the active component in numerous inflammatory conditions. We believe the nature of the compound and its human origin should facilitate a faster regulatory approval path in most countries compared to the traditional new drug therapies."
More about Zertane™ Phase III Clinical trial Results
On another note, CEO Wingerter added: "Our May 23, 2011 press release relating to the results of our Phase III study for our male sexual dysfunction drug, Zertane™, used for the treatment of premature ejaculation, generated significant inquiries that led us to provide additional information on our website (http://ampiopharma.com/products/faqs-about-pe/) about the medical condition and the trial results in a Q&A format. Ampio expects to shortly present a web-based conference of the trial results that will include comparisons to published data on the only other PE drug currently marketed in Europe as well as our commercial strategic plan for this product."
About Ampio
Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for metabolic disease, eye disease, kidney disease, inflammation, CNS disease, and male sexual dysfunction. The product pipeline includes new uses for previously approved drugs and new molecular entities. By concentrating on development of new uses for previously approved drugs, approval timelines, costs and risk of clinical failure are reduced because these drugs have strong potential to be safe and effective while their shorter development times can significantly increase near term value. A key strategy includes actively exploring partnership, licensing and other collaboration opportunities to maximize Ampio's product development programs.
Forward-Looking Statements
Ampio's statements in this press release that are not historical fact and that relate to future plans or events are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by use of words such as "believe," "expect," "plan," "anticipate" and similar expressions. These forward-looking statements include our expectations regarding the conduct and completion of the Ampion trials, the expected results of the trials, our plan to conduct additional Ampion trials, and the likelihood of faster regulatory approval for Ampion. Forward-looking statements involve risks and uncertainties, such as unexpected delays in clinical trials, adverse events identified during trials, lack of efficacy compared to existing treatments, and inability to obtain expedited regulatory approvals, and similar events. The risks and uncertainties involved include those risks detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including Ampio's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
Contact:Investor RelationsAmpio Pharmaceuticals, Inc.303-418-1000
SOURCE Ampio Pharmaceuticals, Inc.
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The present "standard of care" treatment for this condition is the injection of a short acting local anesthetic agent combined with a long acting steroid into and around the joint. In the Ampion trial the mitigation of pain and loss of function caused by osteoarthritis will be assessed at intervals from the time of injection. Patients will be evaluated for 72 hours and various parameters will be followed to demonstrate that Ampion™ is well tolerated and provides pain relief through decreased inflammation as well as demonstrated improvement in the range of motion of the knee.
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Dr. David Bar-Or, MD, Ampio's Chief Scientific Officer, noted, "We discovered this molecule in patients with severe head injury who experienced decreased immune/inflammatory function. The molecule is produced in the body from our own serum albumin and is the most abundant protein in human plasma. We realized from our studies in human tissue that this molecule is an integral part of the innate control of inflammation. We know of many molecules made by our body that increase inflammation but of very few that decrease it. We are hopeful that Ampion™, with few or no side effects, will provide real relief for patients suffering from chronic inflammatory conditions," stated Dr. Bar-Or.
Ampio CEO Don Wingerter noted, "Since Ampion™ is a biologic product made by our bodies, we believe there is the probability of markedly greater safety than steroids or other anti-inflammatory drugs. We anticipate this clinical trial will demonstrate sufficient proof of safety and efficacy to allow longer term studies in which relief may be obtained without prolonged use of steroids, especially when knee replacement is not an option. We are hopeful this drug will provide clinical utility and safety greater than products now selling in the multi-billion dollar market for anti-inflammatories."
Vaughan Clift, MD, Ampio's Chief Regulatory Officer added, "We are very grateful to our Australian Principal Investigators, Dr. Peter Lewis and Dr. Andrew Comley, who helped in the design of the trial and approval process and whose leadership has resulted in encouraging support from local General Practitioners who are also identifying and referring patients into this AIK (Ampion in knee) trial. We expect the trial results will form the basis for submissions to various regulatory agencies to conduct Phase II/III studies of the active component in numerous inflammatory conditions. We believe the nature of the compound and its human origin should facilitate a faster regulatory approval path in most countries compared to the traditional new drug therapies."
More about Zertane™ Phase III Clinical trial Results
On another note, CEO Wingerter added: "Our May 23, 2011 press release relating to the results of our Phase III study for our male sexual dysfunction drug, Zertane™, used for the treatment of premature ejaculation, generated significant inquiries that led us to provide additional information on our website (http://ampiopharma.com/products/faqs-about-pe/) about the medical condition and the trial results in a Q&A format. Ampio expects to shortly present a web-based conference of the trial results that will include comparisons to published data on the only other PE drug currently marketed in Europe as well as our commercial strategic plan for this product."
About Ampio
Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for metabolic disease, eye disease, kidney disease, inflammation, CNS disease, and male sexual dysfunction. The product pipeline includes new uses for previously approved drugs and new molecular entities. By concentrating on development of new uses for previously approved drugs, approval timelines, costs and risk of clinical failure are reduced because these drugs have strong potential to be safe and effective while their shorter development times can significantly increase near term value. A key strategy includes actively exploring partnership, licensing and other collaboration opportunities to maximize Ampio's product development programs.
Forward-Looking Statements
Ampio's statements in this press release that are not historical fact and that relate to future plans or events are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by use of words such as "believe," "expect," "plan," "anticipate" and similar expressions. These forward-looking statements include our expectations regarding the conduct and completion of the Ampion trials, the expected results of the trials, our plan to conduct additional Ampion trials, and the likelihood of faster regulatory approval for Ampion. Forward-looking statements involve risks and uncertainties, such as unexpected delays in clinical trials, adverse events identified during trials, lack of efficacy compared to existing treatments, and inability to obtain expedited regulatory approvals, and similar events. The risks and uncertainties involved include those risks detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including Ampio's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
Contact:Investor RelationsAmpio Pharmaceuticals, Inc.303-418-1000
SOURCE Ampio Pharmaceuticals, Inc.
