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Ampio Injects First Patients in 2nd Phase III, Pivotal Clinical Trial for Ampion™(The STEP Study) for Its FDA Biological

  Ampio Injects First Patients in 2nd Phase III, Pivotal Clinical Trial for
  Ampion™(The STEP Study) for Its FDA Biological License Application (BLA).

PR Newswire

GREENWOOD VILLAGE, Colo., Jan.13, 2014

GREENWOOD VILLAGE, Colo., Jan.13, 2014 /PRNewswire/ -- Ampio Pharmaceuticals,
Inc. (NYSE MKT: AMPE) today announced the 500 patient Phase III pivotal trial
of Ampion^TM for the treatment for osteoarthritis of-the-knee (OAK) has
received IRB approval and FDA IND clearance and that patients enrollment and
treatments have commenced.
http://clinicaltrials.gov/ct2/show/NCT02024529?term=ampio&rank=1

(Logo: http://photos.prnewswire.com/prnh/20120516/MM09116LOGO)

Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, explained "This phase
III, final pivotal clinical trial is a randomized, placebo (vehicle
control)-controlled, double-blind study in which 500 patients with
osteoarthritis (OA) of the knee will be randomized to Ampion^TM 4 ml
intra-articular injection or a 4 ml saline vehicle control. Similar to the
initial Phase III trial (SPRING study) the Primary end point will be assessed
at 12 weeks following a single injection, however we will follow patients for
twenty (20) weeks. The clinical effects of treatment on OA pain will be
evaluated during clinic visits at 6, 12 and 20 weeks using WOMAC^R
osteoarthritis index and Patient's Global Assessment (PGA) of disease
severity. Patient safety will be monitored by recording adverse events,
concomitant medications, physical examination, vital signs and laboratory
tests. In addition, a parallel study of a subpopulation of the patients will
be subjected to Magnetic Resonance Imaging (MRI) and testing of serum
biomarkers to evaluate signs of knee cartilage regeneration. The study will
include eight (8) new clinical sites additional to the nine (9) sites
previously utilized in the SPRING study."

About Osteoarthritis
Osteoarthritis is the most common form of arthritis, affecting over 27 million
people in the United States. It is a progressive disorder of the joints
involving degradation of the intra-articular cartilage, joint lining,
ligaments, and bone. The incidence of developing osteoarthritis of the knee or
hip over a lifetime is approximately 46% and 25%, respectively. Certain risk
factors in conjunction with natural wear and tear lead to the breakdown of
cartilage. Osteoarthritis is caused by inflammation of the soft tissue and
bony structures of the joint, which worsens over time and leads to progressive
thinning of articular cartilage. Other symptoms include narrowing of the joint
space, synovial membrane thickening, osteophyte formation and increased
density of subchondral bone.

About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company
primarily focused on the development of therapies to treat prevalent
inflammatory conditions for which there are limited treatment options. We are
developing compounds that decrease inflammation by (i) inhibiting specific
pro-inflammatory compounds by affecting specific pathways at the protein
expression and at the transcription level; (ii) activating specific
phosphatase or depletion of the available phosphate needed for the
inflammation process; and (iii) decreasing vascular permeability.

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 without limitation, under Ampio's Annual Report on Form
10-K and Quarterly Reports on Form 10-Q. Ampio undertakes no obligation to
revise or update these forward-looking statements, whether as a result of new
information, future events or otherwise.

Investor Contact: Rick Giles, Director of Investor Relations, Ampio
Pharmaceuticals, Inc. Direct: (720) 437-6530, Email: rgiles@ampiopharma.com

SOURCE Ampio Pharmaceuticals, Inc.

Website: http://www.ampiopharma.com
 
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