By 01/03/2012 | Press Release
GREENWOOD VILLAGE, Colo. , Jan. 3, 2012 -- Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE - News) ("Ampio" or the "Company"), a company that discovers and develops new uses for previously approved drugs and new molecular entities ("NMEs"), today announced that it is has completed the expanded patient enrollment phase of its Ampion™ In Knee (AIK) trials in Australia . Forty-two (42) patients were added to the original sixty (60) patient study.
Dr. Vaughan Clift , Chief Regulatory Officer of Ampio, noted, "The initial trial was an important clinical milestone for the company as it was the first time that Ampion™ was administered as a treatment for an inflammatory condition in humans and was well tolerated with no reported treatment related adverse events. Details of the initial trial can be found on the Australian clinical trials register at http://www.anzctr.org.au/trial_view.aspx?ID=343138. The absence of any adverse events in the initial AIK study provided the basis for IRB approval of this expanded trial, with 42 additional patients, each receiving either a direct intra-articular injection of Ampion™ or the saline placebo."
Dr. Clift continued, "Dr. Bar-Or, Ampio's Chief Scientific Officer, discovered the Ampion™ molecule while studying patients with immune suppression following head injury and has published numerous scientific papers on its immune modulating effect in vitro in prominent scientific journals and presented his findings at national and international scientific meetings. Because Ampion™ is a molecule produced by humans in response to injury, is present in commercial human serum albumin (HSA) preparations that have been administered intravenously to restore the oncotic pressure of millions of hypoalbuminemic patients, we have gained substantial comfort about the safety profile of this small molecule-Ampion™. Further, as blood derived products are currently managed by the Center for Biologics Evaluation and Research (CBER) division of the FDA, we believe Ampion™ will be classified and regulated as a biologic. The raw clinical data from the trial is now being evaluated by biostatisticians employed by the Clinical Research Organization that has conducted the trial and results are expected to be available in the next four to six weeks.
"We are hopeful this naturally occurring molecule may provide safe and effective pain relief in humans," commented Dr. Bar-Or. "Medical treatment of chronic pain would be improved if physicians were able to prescribe an effective analgesic/anti-inflammatory medicine without the damaging side effects associated with steroids, such as infection, ruptured tendons and weakening of joints when injected locally."
About Osteoarthritis (OA)
OA is the most common type of arthritis affecting about 27
million Americans and is more common in women than men. It
is often referred to as "wear-and-tear" arthritis
as it is caused by the breakdown of the cartilage that
cushions the ends of the bones, causing them to rub
together. OA often causes significant pain and disability
particularly in the knees, hips, back, and hands. There is
currently no efficacious therapy that combines analgesic
and anti-inflammatory effects without side effects.
About Ampion ™
Ampion™ is a non-steroidal anti-inflammatory drug that
appears to have a significant role in the homeostasis of
inflammation, so that it has the potential to be used in a
broad array of inflammatory conditions which impact
millions of patients. Ampion™ is a molecule produced by
humans in response to injury and is protected globally by
composition of matter and use patents including means of
synthetically manufacturing the molecule and method of
extraction from commercial albumin preparations.
About Ampio Pharmaceuticals
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 ("NMEs"). 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.
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 risks
associated with clinical trials, expected results,
regulatory approvals, and changes in business conditions
and similar events. The risks and uncertainties involved
include those 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.
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