Navigation Links
Ampio Advances NCE001 Cancer Drug into Preclinical Development Following Successful Recent Financing and the Granting of Patents in USA, Canada, Europe and China
Date:7/16/2012

GREENWOOD VILLAGE, Colo., July 16, 2012 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), a biopharmaceutical company developing repurposed drugs and new molecular entities (NMEs) that treat inflammatory diseases, including osteoarthritis, diabetic macular edema (DME) and sexual dysfunction and conducting clinical trials on its four lead drugs (Ampion™, Optina™, Zertane™ & Zertane-ED™) announced today the advancement of NCE001, from its proprietary methylphenidate derivatives family of compounds, to preclinical development for the treatment of glioblastoma multiforme, renal cell carcinoma and inflammatory breast cancer following the granting of multiple composition of matter and use patents in the USA, Canada, Europe and China.

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

Dr. David Bar-Or, Ampio's Chief Science Officer (CSO) explained the focus on this particular drug, "NCE001 activates a specific intracellular phosphatase largely involved in inflammation, angiogenesis and cell proliferation pathways and has demonstrated remarkable in vitro effects on aggressive cancer cells of these three lineages.  We believe it may play an important role in treating these particularly aggressive cancers.  Ampio has entered into a development agreement with Syngene International (Bangalore, India) to manufacture and conduct all preclinical stages of development of NCE001 all the way to an IND submission to the FDA. These three cancers do not have adequate treatment options so NCE001 may qualify for an accelerated approval path by regulatory agencies including the FDA."

Michael Macaluso, Ampio's CEO noted, "Our recent successful financing and our confidence that we will successfully out-license our more advanced drugs means we need to begin development of lead compounds to replace them.  The pre-clinical demonstration of efficacy of NCE001, the accelerated approval process, the relative low cost of development through an IND and the strong composition of matter patents recently granted worldwide make this a prudent decision at this time."

FDA's Accelerated Approval Process:

FDA's accelerated approval regulations allow accelerated approval of products to treat serious or life-threatening diseases based on surrogate endpoints that are reasonably likely to predict clinical benefit. From December 11, 1992, to July 1, 2010, the FDA granted accelerated approval to 35 oncology products for 47 new indications. Clinical benefit was confirmed in post-approval trials for 26 of the 47 new indications, resulting in conversion to regular approval. The median time between accelerated approval and regular approval of oncology products was 3.9 years (range = 0.8–12.6 years) and the mean time was 4.7 years, representing a substantial time-savings in terms of earlier availability of drugs to cancer patients.

About Syngene International:

Syngene is an internationally reputed contract research and manufacturing organization with multidisciplinary skills in chemistry and biology services. From early stage discovery and process development through to cGMP manufacturing, Syngene provides customized services to pharmaceutical and biotechnology majors, on a strong platform of confidentiality and intellectual property protection.

About Ampio

Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for inflammation, eye disease, kidney disease, CNS disease, metabolic 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 opportunities to maximize Ampio's product development programs. For more information about Ampio, please visit our website, www.ampiopharma.com.

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, 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.

Contact: Rick Giles, Investor Relations, Ampio Pharmaceuticals, Inc. 720-437-6500


'/>"/>
SOURCE Ampio Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Ampio Pharmaceuticals Announces Exercise of Over-Allotment Option
2. Ampio Pharmaceuticals Announces Pricing of Public Offering of 4,615,400 Shares of Common Stock
3. Ampio Pharmaceuticals Announces Proposed Public Offering
4. Ampios CEO and CSO Send Message to Shareholders
5. Four-Time Triathlon World Champion Melanie McQuaid Selects Polar USA as Official Heart Rate Training Solution
6. Ampio Pharmaceuticals Schedules 2012 Update Webcast
7. Four Californians Selected As Breakaway from Cancer® Champions To Be Honored During Amgen Tour of California
8. Ampio Awarded US and Canadian Patents that will Bolster the Commercialization of Optina™ for the treatment of Diabetic Macular Edema (DME)
9. Medical Imaging Information Systems Market to 2017 - Replacement of Legacy Systems and Advances in Software Present Growth Opportunities
10. Selexis Lubris Partnership Advances Difficult-to-Express Protein Towards Clinic
11. Rigel Advances Asthma Programs: Two Inhaled Drug Candidates Take Aim at Acute and Chronic Lung Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... FRANCISCO, Calif. , June 24, 2016 /PRNewswire/ ... ), a biopharmaceutical company developing novel therapeutics for ... unmet needs, today announced the closing of its ... of common stock, at the public offering price ... in the offering were offered by GBT. GBT ...
(Date:6/24/2016)... , June 24, 2016 The Academy of ... recommendations that would allow biopharmaceutical companies to ... entities that make formulary and coverage decisions, a move ... of new medicines. The recommendations address restrictions ... appear on the drug label, a prohibition that hinders ...
(Date:6/24/2016)... -- According to a new market research ... Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, 8mm, ... Purchase (Retail, Non-Retail) - Trends & Global Forecasts to ... for the forecast period of 2016 to 2021. This ... 2021 from USD 1.65 Billion in 2016, growing at ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... ... a crisis. Her son James, eight, was out of control. Prone to extreme mood shifts ... upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a knife ... and say he was going to kill them. If we were driving on the ...
(Date:6/24/2016)... ... 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that 20 ... by their peers for this recognition are considered among the top 2 percent of ... honors as members of this year’s Legal Elite Hall of Fame: Miami Shareholders ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Comfort Keepers® ... American Cancer Society and the Road To Recovery® program to drive cancer patients to ... and other adults to ensure the highest quality of life and ongoing independence. ...
(Date:6/24/2016)... ... 2016 , ... People across the U.S. are sharpening their pencils and honing ... contest in which patients and their families pay tribute to a genetic counselor by ... Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In ...
(Date:6/24/2016)... ... 24, 2016 , ... The Haute Beauty Network, affiliated with ... as a prominent plastic surgeon and the network’s newest partner. , Dr. ... handsome men, look naturally attractive. Plastic surgery should be invisible.” He stands by ...
Breaking Medicine News(10 mins):