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Ore Pharmaceuticals Files Investigational New Drug Application With FDA

Posted on: Tuesday, 1 July 2008, 06:00 CDT

Ore Pharmaceuticals Inc. (NASDAQ:ORXE) announced today that it has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for GL1001, the first clinical-stage inhibitor of the ACE2 enzyme. This orally administered small molecule is being developed primarily for inflammatory bowel disease (IBD). Treatment with GL1001 has decreased several disease activity measures in in vivo models of IBD as well as other gastrointestinal diseases with related injury due to inflammation. GL1001 was previously administered in a Phase I single ascending dose clinical study completed in the United Kingdom, where it was well tolerated and exhibited pharmacokinetics consistent with once daily dosing.

Pending clearance of the IND, the Company plans to initiate a multiple ascending dose clinical trial in September 2008 to assess tolerability, pharmacokinetics and pharmacodynamics of GL1001. Additionally, Ore Pharmaceuticals is undergoing preparations to test this first-in-class compound in later-stage clinical trials. The Company is pursuing the clinical development of GL1001 in parallel with its efforts to establish an out-licensing or partnering arrangement to advance the compound into later-stage clinical trials.

Ore Pharmaceuticals used its proprietary Indication Seeking Program to reposition GL1001 from the indication of obesity pursued by the original sponsor to IBD (which includes ulcerative colitis and Crohn's disease). Company data indicate additional potential applications in related conditions such as gastritis, prevention or healing of gastric ulcer secondary to NSAIDs, and pancreatitis. Ore Pharmaceuticals has an extensive intellectual property estate of issued patents for GL1001 covering both the drug target and compound chemistry through at least 2020.

Ore Pharmaceuticals Chief Executive Officer, Charles L. Dimmler, III, commented, "The filing of the first IND in the Company's history is a significant milestone for Ore Pharmaceuticals. We expect this first-in-class compound to be an attractive in-licensing candidate for pharmaceutical companies."

Ore Pharmaceuticals Senior Vice President, Clinical Development, Stephen Donahue, M.D., said, "We are pleased to resume clinical development of GL1001, a novel compound of high quality that offers significant opportunity as a potential oral treatment of IBD that may be added to any of the existing therapies."

"We feel that the new indication is well-supported by the data that Ore generated," said Thomas Barnes, Ph.D., SVP of Discovery. "GL1001 was the first molecule we attempted to reposition and the success of our integrative pharmacology technology in identifying IBD and other GI inflammatory diseases is a testament to the robustness of the platform. By observing an anti-inflammatory mechanism, spatially confined to the GI tract and its accessory organs, we were able to create and refine our hypothesis for the treatment of IBD."

About Inflammatory Bowel Disease

IBD is a chronic and often debilitating disorder characterized by inflammation and scarring in the digestive tract. There are two main types of inflammatory bowel disease: ulcerative colitis and Crohn's disease, and the conditions affect approximately one million patients in the United States. Although the underlying etiology of this relapsing and remitting disease is unknown, it involves genetic, environmental and immunologic factors. Current treatments have significant limitations in effectiveness or cause adverse events of varying severity.

Ore Pharmaceuticals Overview

Ore Pharmaceuticals is a commercial drug development company. We have applied our proprietary know how in integrative pharmacology to identify potential new uses for drug candidates. We are now focused on developing certain compounds for which we have found such new uses. Our goal is to meet the demands of the pharmaceutical industry by supplying development stage drug compounds to enrich drug development pipelines. We currently have a lead compound, GL1001, in our own development pipeline for which we have identified potential new therapeutic uses to treat gastrointestinal inflammation, including inflammatory bowel disease (IBD, including ulcerative colitis and Crohn's disease) and other conditions. GL1001 has shown indications of efficacy at relevant doses in in vivo testing for IBD. We intend to initiate clinical testing of GL1001 in 2008 while actively seeking to out-license or partner the further clinical development and commercialization of the compound. We have rights to develop additional compounds that have been tested in clinical stage testing by our partners but that are in later stages of preclinical testing for the uses we have discovered. Visit us at orepharma.com or call 1-877-ORE-PHRM.

Safe Harbor Statement

This press release contains "forward-looking statements," as such term is used in the Securities Exchange Act of 1934, as amended. Such forward-looking statements include the Company's ability to identify strategies for making its businesses successful and the impact of such strategies on our business and financial performance and on shareholder value. Forward-looking statements typically include the words "expect,""anticipate,""believe,""estimate,""intend,""may,""will," and similar expressions as they relate to Ore Pharmaceuticals or its management. Forward-looking statements are based on our current expectations and assumptions, which are subject to risks and uncertainties. They are not guarantees of our future performance or results. Our actual performance and results could differ materially from what we project in forward-looking statements for a variety of reasons and circumstances, including particularly risks and uncertainties that may affect the Company's operations, financial condition and financial results and that are discussed in detail in the Company's Annual Report on Form 10-K and our other subsequent filings with the Securities and Exchange Commission. They include, but are not limited to: whether we can obtain from our partners development rights to repositioned compounds; whether we can successfully develop to a sufficient stage and outlicense repositioned compounds on acceptable terms and whether such outlicensed compounds are then successfully developed and commercialized and generate sales and resulting milestone payments from development and royalties from sales for the Company,; whether we will be able to begin to generate sufficient new revenue from licensing or other transactions soon enough to support our operations; whether there will be valid claims for indemnification from the buyers of our Genomics Assets; whether there will be claims from the landlords of the leased properties we have assigned to buyers of our Genomics Assets or our Preclinical Division that we would be required to pay as guarantors of such leases; whether we will be able to collect amounts due under the terms of the promissory note from the buyer of our Genomics Assets; whether we will be able to manage our existing cash adequately and whether we will have access to financing on sufficiently favorable terms to maintain our businesses and effect our strategies, including development of repositioned compounds; whether we will be able to recruit and retain qualified personnel for our commercial drug development business; whether we will be able to find a sufficiently attractive strategic option to develop our molecular diagnostics capability that does not require significant use of our financial assets; potential negative effects on our operations and financial results from workforce reductions and the transformation of our business; and the possibility of further write-down of the value of certain intangible assets of the Company. Ore Pharmaceuticals Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: Business Wire

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