Ore Pharmaceuticals Begins Clinical Trial Of GL1001 - Inflammatory Bowel Disease Drug Candidate's First Multiple Dose Trial

Main Category: Irritable-Bowel Syndrome
Also Included In: GastroIntestinal / Gastroenterology;  Crohn's;  Clinical Trials / Drug Trials
Article Date: 03 Oct 2008 - 1:00 PDT

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Ore Pharmaceuticals Inc. (NASDAQ: ORXE) announced today that it has initiated dosing subjects with GL1001, the Company's lead drug candidate, in a multiple ascending dose clinical trial. GL1001, the first clinical-stage inhibitor of the ACE2 enzyme, is an orally administered small molecule that has decreased several disease activity measures in in vivo models of inflammatory bowel disease (IBD) and gastritis. GL1001 was administered previously in a Phase I single ascending dose clinical study completed in the United Kingdom, where it was well tolerated and exhibited favorable pharmacokinetics consistent with once daily dosing. Ore Pharmaceuticals is pursuing the clinical development of GL1001 in parallel with its efforts to out-license or partner the development of the compound in later-stage clinical trials.

Stephen Donahue, M.D., Senior Vice President of Clinical Development at Ore Pharmaceuticals, said, "We are pleased to have begun multiple dose clinical testing of this novel, repositioned drug candidate for treatment of IBD. GL1001 was initially developed to treat obesity. Our current trial will assess the tolerability, pharmacokinetics and pharmacodynamics of the compound as a potential drug to treat IBD."

Ore Pharmaceuticals Chief Executive Officer, Charles L. Dimmler, III, commented, "Beginning the clinical trial of GL1001 is a significant first milestone for the Company resulting from our focus on drug development. We believe GL1001 offers an important partnering opportunity because it's a first in class compound. It's a compound we understand well, has been extensively studied, and shows strong potential to meet a significant unmet medical need."

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. Ore Pharmaceuticals currently has three compounds in its development pipeline for which we have identified potential new therapeutic uses: GL1001 (in clinical trials for Inflammatory Bowel Disease), romazarit (beginning development for metabolic diseases), and tiapamil (beginning development for CNS.) Ore Pharmaceuticals is currently seeking a development partner for the late-stage development of GL1001 and tiapamil. We have rights to develop additional compounds that have been tested in clinical trials by our partners but that are in late stages of preclinical testing for the uses we have discovered. Visit us at http://www.orepharma.com.

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; 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.

Ore Pharmaceuticals