GAITHERSBURG, Md. - (Business Wire) Ore Pharmaceuticals Inc. (NASDAQ: ORXE) announced today that Chief Executive Officer and President Charles L. Dimmler, III, gave a presentation at the Rodman & Renshaw 5
th Annual Global Healthcare Conference, that included certain research and development findings, the Company
’s current compound development status, and information about its recently published patent application regarding stratification and treatment of the majority of breast cancer patients based on their estrogen receptor alpha status.
Research and Development Findings
Mr. Dimmler presented the Company’s findings resulting from its integrative pharmacology capability. Ore Pharmaceuticals uses a multi-pronged approach to discover new therapeutic indications for drugs and drug candidates. The Company has evaluated more than 100 compounds and, for 28 of those compounds, has found a potential new therapeutic use. To date, eight of those compounds have yielded positive results for the potential new therapeutic use in in vivo efficacy tests, and four additional compounds are currently being tested in such models. Ore Pharmaceuticals expects to acquire two to three of these compounds each year for its own clinical development pipeline.
Pipeline Status
Ore Pharmaceuticals’ lead drug candidate in its development pipeline is GL1001, a first-in-class, orally administered small molecule. Mr. Dimmler presented preclinical data validating the beneficial effect of GL1001 in a model of ulcerative colitis, and showing the protective effect of GL1001 on gastritis induced by nonsteroidal anti-inflammatory drugs. Ore Pharmaceuticals plans to submit an investigational new drug (IND) application to the FDA in late June and, pending approval, will proceed with a clinical trial of GL1001 in September. The Company plans to acquire and then out-license additional compounds for its development pipeline.
AT1-R Status and Background
Mr. Dimmler also discussed the Company’s patent applications related to angiotensin II type I receptor (AT1-R) status as a determinant for stratifying and treating infiltrating ductal carcinoma (IDC) of the breast. Ore Pharmaceuticals has discovered a correlation, in patients with IDC of the breast, between estrogen receptor alpha positive (ER+) status and angiotensin II type I receptor (AT1-R) mRNA expression. The Company’s scientists found that upregulation of AT1-R is present in IDC patients who are ER+ and that ER+ IDC tumor cells responded to pharmacologic intervention with AT1-R antagonists. Ore Pharmaceuticals has supported its findings using in vitro and in vivo models. The findings could help stratify breast cancer patients, thereby facilitating more effective treatment with AT1-R antagonists either alone or in combination with other therapies. The Company’s patent filing claims include:
- A method of selecting female breast cancer patients for appropriate treatment
- A method for treating a segment of breast cancer patients
- A method for determining whether breast cancer tumors are responsive to selective estrogen receptor modulator treatment
Mr. Dimmler also presented preclinical data showing that the activity of an AT1-R antagonist (candesartan, a hypertension drug) is similar to that of tamoxifen, a selective estrogen receptor modulator used in treating breast cancer for decades. The Company has additional studies under way in other breast cancer models, and is seeking to out-license the intellectual property to a pharmaceutical company with a currently marketed angiotensin II type I receptor antagonist.
Breast cancer is the leading cause of cancer-related mortality among women worldwide. In 2006, more than 450,000 cases of the disease were diagnosed in the seven major pharmaceutical markets, 75% of which were diagnosed as infiltrating ductal carcinoma, a cancer type with a propensity to metastasize via the lymphatic system to other tissues and organ systems. Despite recent drug approvals in the adjuvant and metastatic setting, high unmet needs still persist for this tumor type as the overall survival rate remains below five years.
Charles L. Dimmler, III, Ore Pharmaceuticals CEO and President, commented, “Ore Pharmaceuticals is advancing drug candidates based on our proprietary integrative pharmacology. Our program identifies new indications for safe, undervalued drug candidates, and, we believe, could extend the value and competitive viability of marketed drugs. We are pleased with the data related to GL1001 and believe it is an excellent candidate for out-licensing or co-development in IBD and related diseases, which are areas of large unmet medical need. Additionally, our AT1-R findings represent an opportunity to extend the use and patent life of existing therapies while offering significant benefit to a large number of breast cancer patients.”
Presentation Available
Mr. Dimmler’s presentation is archived on the Ore Pharmaceuticals web site at www.orepharma.com.
Ore Pharmaceuticals Overview
Ore Pharmaceuticals is a commercial drug development company. We apply our proprietary know how in integrative pharmacology to identify potential new uses for drug candidates. Our goal is to meet the demands of the pharmaceutical industry by supplying development stage drug compounds to enrich drug development pipelines. We do this in two ways: We identify uses for stalled or failed drug compounds provided by our pharmaceutical partners, and, for our own pipeline, we identify new uses for drug compounds available in the public domain. Our own pipeline may also include compounds that our pharmaceutical partners decide not to develop for new uses we identify. We currently have one 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. Visit us at orepharma.com or call 1-877-ORE-PHRM.
Ore Pharmaceuticals Inc.
Philip L. Rohrer, Jr. (investors)
Chief Financial Officer
301-361-4400
prohrer@orepharma.com
or
Christopher Culotta (investors and media)
Senior Director, Strategic Communications
240-361-4433
cculotta@orepharma.com
