Ampio Pharmaceuticals Provides Clinical Updates
GREENWOOD VILLAGE, Colo., June 3, 2013
GREENWOOD VILLAGE, Colo., June 3, 2013 /PRNewswire/ --Ampio Pharmaceuticals,
Inc. (NASDAQ: AMPE) today announced an update on its clinical progress for
Ampion^TM, Optina^TM, the sexual dysfunction portfolio, and Luoxis
In the SPRING trial, Ampion is being evaluated for its effect on reducing pain
in osteoarthritis of the knee, measured by the WOMAC scale, as a single
intra-articular injection into the knee in 4 milliliter (mL) and 10 milliliter
(mL) volumes as compared to placebo at twelve weeks. The study treated in
excess of the targeted 320 patient goal in less than four weeks. This was
designed as a run-in to a Phase III pivotal trial, which Ampio will initiate
once the optimal volume is determined and the proposed pivotal trial is
properly powered to achieve its scientific objectives. By June 7^th, all
patients in the SPRING trial will have received the three follow-up phone
calls and the six (6) week exam that followed the baseline exam at time of
dosing. Clinical results from the completed trial, which includes additional
follow-up calls and a final exam, will be made available in the third quarter
of 2013. These results will be the basis for corporate strategy and business
negotiations going forward.
Optina (danazol) is being tested in a 505(b)(2) trial to treat diabetic
macular edema (DME). This may become the pivotal trial as a portion of
505(b)(2) drugs receive FDA registration based on a single clinical trial.
The randomized, placebo-controlled, double-masked, multicenter United States
trial is expected to enroll approximately 450 patients. The primary endpoint
is improvement in best-corrected visual acuity (BCVA) compared to placebo.
Secondary endpoints are 1) categorical changes in visual acuity (VA) in
treated patients compared to placebo; 2) reduction in central macular
thickness (CMT) in treated patients compared to placebo; and, 3) safety and
tolerability of the two Optina™ doses. Interim four week masked data of
approximately 360 patients will be announced in the fourth quarter of 2013.
Full twelve week top-line preliminary data will be announced in the first
quarter of 2014.
Sexual Dysfunction Portfolio
Ampio is in late-stage negotiations to license Zertane, for treatment of
premature ejaculation, and Zertane-ED, for treatment of concomitant premature
ejaculation and erectile dysfunction.
Ampio has also submitted the application to the Therapeutic Goods
Administration (TGA) for approval of Zertane in Australia. The Company expects
to receive marketing authorization (approval) in the first half of 2014. An
approval in Australia will open up numerous markets worldwide including South
Korea and Brazil where Ampio has licensing agreements. This could also be
important for additional business negotiations and revenue for Ampio.
Luoxis Diagnostics, Inc.
Luoxis Diagnostics recently completed a private placement financing to
initially fund the carve-out of Ampio Pharmaceuticals. Under terms of the
private placement, which raised $4.7 million in gross proceeds, Ampio will
retain approximately 80% ownership of the newly formed in-vitro diagnostics
company focused on the commercialization of the Oxidation Reduction Potential
("ORP") technology platform. Luoxis, under a newly appointed management team,
is now fully funded to pursue FDA and CE Mark clearance for its proprietary
point-of-care diagnostic system. In support of these regulatory submissions,
and subsequent commercialization of the ORP product, will be data
demonstrating the diagnostic capability of the product to detect serious
medical conditions within more than 5,000 patients. This data will be
available in 3^rd quarter 2013.
Ampion is a non-steroidal anti-inflammatory biologic that has the potential to
be used in a broad array of inflammatory conditions and autoimmune diseases.
The active ingredient is aspartyl-alanyl diketopiperazine, referred to as
DA-DKP, which is derived from two amino acids from human albumin and appears
to have a significant role in the homeostasis of inflammation. Ampion is
protected by composition of matter, use, and synthetic form patents. Ampio has
published a number of studies and articles on the anti-inflammatory activity
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
About The Sexual Dysfunction Portfolio
Zertane is a repurposed, on-demand, orally dissolving tablet to treat
premature ejaculation, a condition that has a major impact on the quality of
life for men and their sexual partners. The active ingredient, tramadol, has
multiple mechanisms of actions that can delay ejaculation. This drug also has
an excellent safety record established during 30 years of human use for other
medical indications. Zertane-ED, a patented combination of Zertane and any
PDE-5 inhibitor, can be used to treat premature ejaculation and erectile
dysfunction. It is estimated that 41% of men with erectile dysfunction are
comorbid for premature ejaculation.
About Luoxis Diagnostics, Inc.
Luoxis Diagnostics is an in-vitro diagnostics company focused on the
development and global commercialization of a "point of care" hand held device
and disposable strips that measures, from a single drop of blood, the presence
of oxidative stress and anti-oxidant reserves in a patient. ORP is an
important measure in the detection of both critical and chronic illnesses, and
is a novel marker of patient morbidity across a wide range of diseases and
conditions. There are numerous clinical indications for this homeostatic
parameter for which there is no currently available test.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company
focused on the rapid development of therapies to treat prevalent inflammatory
conditions for which there are limited treatment options. We are developing
compounds that decrease inflammation by (i) inhibition of specific
pro-inflammatory compounds by affecting specific pathways at the protein
expression and at the transcription level or (ii) activation of a specific
phosphatase or depletion of the available phosphate needed for the
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, 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:
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:
Director of Investor Relations
Ampio Pharmaceuticals, Inc.
Direct: (720) 437-6530
SOURCE Ampio Pharmaceuticals, Inc.
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