Ampio Pharmaceuticals Announces Active IND for Optina™ for the Treatment of Diabetic Macular Edema (DME)

 Ampio Pharmaceuticals Announces Active IND for Optina™ for the Treatment of
                         Diabetic Macular Edema (DME)

PR Newswire

GREENWOOD VILLAGE, Colo., Jan. 22, 2013

GREENWOOD VILLAGE, Colo., Jan. 22, 2013 /PRNewswire/ — Ampio Pharmaceuticals,
Inc. (Nasdaq: AMPE) announced today that the FDA has accepted the Company's
IND for Optina™ for the treatment of diabetic macular edema (DME). Ampio plans
to commence enrollment in a clinical trial in the first quarter of 2013. The
FDA granted Optina™ 505(b)(2) status in July, 2012. Drugs designated under
this pathway can be approved on a single trial.

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

Michael Macaluso, Chairman and CEO of Ampio, commented "Having an active IND
for Optina™ is an important milestone in the advancement of our lead compounds
from our pipeline. This is a significant step in the approval process through
an agreed upon 505(b)(2) pathway with the FDA. DME is a devastating
complication of diabetes and we believe, based on a previous phase 2 study
performed in Canada and extensive in vitro data, that Optina™ has the
potential to become a valuable treatment option for DME. "

The planned multicenter trial is designed to evaluate the safety and efficacy
of oral Optina™ compared with placebo given over a period of 12 weeks in adult
patients with DME. Patients will be randomized to receive one of two doses of
Optina™ (0.5mg per BMI and 1.0mg per BMI per day) or placebo. After patients
have completed 4 weeks of initial treatment, an interim analysis will occur to
determine the best dose of Optina™. Following the 12 week active treatment
period, there will be a further 4 week washout period to determine regression
of treatment effect. The primary endpoint is improvement in visual acuity
(VA), defined by responder status, compared to placebo. Secondary endpoints
are 1) measurements of changes in VA and central macular thickness (CMT) in
treated patients compared to placebo and, 2) safety and tolerability of the
two Optina™ doses. Following treatment and washout, patients will be assessed
for vision regression and a 12 week open label extension study will be offered
to evaluate the duration of effect of the optimal dose. A total of 450
patients are expected to enroll.

David Bar-Or, M.D., Chief Scientific Officer and Director of Ampio added, "I
am very pleased we have been able to move Optina™ forward. The systemic nature
of diabetes which affects, among other things, the microvascular system is
manifested by local and systemic inflammation. Optina™ will be administered
orally without the requirement for an injection into the eye, and it also has
the potential to treat other systemic complications of diabetes such as
nephropathy."

About Optina™^
Optina™ is a drug based on a low dose of the weak androgen,
low-molecular-weight, very lipophilic steroid danazol. Oral administration of
low dose danazol to patients with DME is safe with no evidence of serious
adverse events. Ampio's in vitro data suggest that danazol has a biphasic
effect on endothelial cells: At low doses, danazol decreases vascular leakage,
while at higher concentrations an increase in vascular permeability is
observed. This biphasic effect was supported by the efficacy of danazol in
vivo at various BMIs. From Ampio's previously announced results, Optina™
appears to reduce DME in a BMI dosage-adjusted manner and appears to trend
toward improved visual acuity and seems to be safe with few, if any, side
effects.[1] [2]

About Diabetic Macular Edema
Diabetic Macular Edema (DME) is a swelling of the retina indiabeticpatients
due to leaking of fluid from blood vessels within the macula. The macula is
the part of the eye responsible for sharp central vision. There are
approximately 26 million people in the United States with diabetes and DME can
occur in both Type 1 and Type 2 diabetes. Up to 10% of diabetics will develop
DME during their lifetime and up to 75,000 new cases of DME are estimated to
occur each year in the United States[3]. Current treatments include anti-VEGF
drugs, corticosteroid-based regiments, and laser surgery that helps seal the
leaky blood vessels. Drug delivery by injection into the vitreous of the eye
is a limitation of these new treatments because of the potential complications
due to repeated injections into the eye such as infection, pain, hemorrhage
and increased intraocular pressure.

About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a biopharmaceutical company focused on the
rapid development of therapies to treat prevalent inflammatory conditions for
which there are limited treatment options. It aims to provide medicines to
improve the health and quality of life of patients with minimal side effects.
Ampio is developing compounds that decrease inflammation by 1) inhibition of
specific pro-inflammatory compounds by affecting specific pathways at the
protein expression and at the transcription level or 2) activation of a
specific phosphatase or depletion of the available phosphate needed for the
inflammation process. For more information visit: www.ampiopharma.com.

Forward Looking Statement
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, successful commercialization and
marketing of Zertane™ and the combination drug in Korea, 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

[1] Bar-Or D, Thomas GW, Salottolo K, et al. Oral Danazol for DME. Retina
Today. 2012; Vol. 7, No. 7: 68-70. Available at:
http://bmctoday.net/retinatoday/2012/10/article.asp?f=oral-danazol-for-dme

[2] Thomas GW, Rael LT, Bar-Or R, et al. Biphasic effect of danazol on human
vascular endothelial cell permeability and f-actin cytoskeleton dynamics.
Biochem Biophys Res Commun. 2012;421:707-712. Available at:
http://www.ncbi.nlm.nih.gov/pubmed/22542943

[3] Ali, F.A. A review of diabetic macular edema. Digital Journal of
Ophthalmology, vol. 3, no. 6, 1997. Available at:
http://www.djo.harvard.edu/site.php?url=/physicians/oa/387

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
 
Press spacebar to pause and continue. Press esc to stop.