Adherex Announces Corporate Goals for 2006.RESEARCH TRIANGLE PARK Research Triangle Park, research, business, medical, and educational complex situated in central North Carolina. It has an area of 6,900 acres (2,795 hectares) and is 8 × 2 mi (13 × 3 km) in size. Named for the triangle formed by Duke Univ. , N.C. -- Adherex Technologies Inc. (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension :AHX AHX American History X (movie) AHX Abyss' Highest eXperience )(AMEX AMEX See: American Stock Exchange :ADH ADH: see antidiuretic hormone. ), a biopharmaceutical company with a broad portfolio of oncology products under development, today announced its corporate goals for 2006. "2005 was a year in which Adherex achieved many important milestones, including the completion of the first Phase I trial of ADH-1, initiation of two additional Phase Ib/II trials in the U.S. and Europe, the launch of the first Phase II trial of ADH-1, and the in-license and rapid return of eniluracil to the clinic," said William P. Peters, M.D., Ph.D., Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Adherex. "2006 will be an even more important and active year for Adherex, as we continue to aggressively move our drugs forward in their clinical development. Ultimately, shareholder value will be driven by the results of our clinical and laboratory studies. To that end, we expect our 2006 clinical program to yield a significant amount of safety and response data on both ADH-1 and eniluracil, which will help define the optimal disease settings, dose and schedule required for subsequent Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trials. We will also continue to emphasize our preclinical efforts to develop the scope and depth of our cadherin biotechnology platform by advancing the development of our small molecule N-cadherin antagonists as well as other molecules which affect the function of cadherins." ADH-1 In 2006, Adherex expects to optimize the dose and schedule of ADH-1, identify single agent activity in selected tumor types and, where the natural evolution of the development of cancer drugs is to move from single agent trials to combination trials, to evaluate ADH-1 clinically in combination with other cancer therapies. To achieve these objectives, Adherex plans to: - Evolve the European Phase Ib/II weekly dosing study into a Phase II trial in select tumor types by mid 2006. - Expand the ADH-1 development program to include combination trials with other cancer therapies in mid 2006. - Complete the Phase II trial in Canada focused on tumor types where anti-cancer activity has been observed, with release of results of this first Phase II study targeted for second half of 2006 at an appropriate scientific venue. In addition, we expect to add additional clinical investigators and trial sites in the U.S. to this Phase II program. - Continue the U.S. Phase Ib/II daily x 5 (Monday through Friday) dosing study. - Publish the completed results of the Phase I trial. - Present interim results of ongoing Phase Ib/II trials at the 2006 American Society for Clinical Oncology (ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company ) conference or other appropriate scientific venue. - Present preclinical ADH-1 data at the 2006 American Association for Cancer Research Wikipedia is not the place for advertisement or self-advertising. The American Association for Cancer Research (AACR) is an organization based in Philadelphia, Pennsylvania, that focuses on all aspects of cancer research including basic, clinical and translational (AACR AACR American Association for Cancer Research AACR Anglo-American Cataloging Rules AACR Australasian Association of Cancer Registries AACR African Armed Conflicts Resolved ) conference. Eniluracil Adherex in-licensed eniluracil, an irreversible inhibitor of dihydropyrimidine dehydrogenase Dihydropyrimidine dehydrogenase (DPD) is an enzyme that is involved in pyrimidine degradation. It is the initial and rate-limiting step in pyrimidine catabolism. It catalyzes the reduction of uracil and thymine. (DPD DPD Department of Planning and Development DPD Dihydropyrimidine Dehydrogenase DPD Dead Peer Detection (Cisco) DPD Division of Parasitic Diseases (US CDC) DPD Dominant Wave Period DPD Drug Product Database ), from GlaxoSmithKline in July 2005. In 2006, the Company expects to complete a series of studies to optimize the proprietary method of administration for the combination of eniluracil and 5-FU. To achieve this objective, Adherex plans to: - Conclude the recently started Phase I trial of the combination of eniluracil and 5-FU in patients with solid tumors in the third quarter of 2006 to provide optimal dose, schedule and safety data for the combination based on Adherex's proprietary approach. - Begin accrual of patients into a Phase II breast cancer trial of the combination of eniluracil and 5-FU by the fourth quarter of 2006, following completion of the Phase I trial mentioned above. - Initiate a Phase I/II trial in liver cancer Liver Cancer Definition Liver cancer is a relatively rare form of cancer but has a high mortality rate. Liver cancers can be classified into two types. in Asia in the second quarter of 2006 to establish the safety of Adherex's proprietary dose and schedule in the Asian population and to provide initial efficacy information in hepatocellular (liver) cancer, for which the Company has received orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the designation. - Initiate and conclude a Phase I trial of single agent eniluracil in patients with colorectal tumors in mid 2006 to refine our understanding of the duration of eniluracil effects on the enzymes involved in the metabolism of 5-FU. - Present data at appropriate scientific conference(s) on our new understanding of the effects of eniluracil on 5-FU metabolism. Other Programs With respect to its other programs, Adherex plans to: - Continue to coordinate with the Children's Oncology Group the initiation of a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , controlled study for STS (Synchronous Transport Signal) The electrical equivalent of the SONET optical signal. In SDH, the European counterpart of SONET, STS is known as STM (Synchronous Transport Module). as a protectant protectant /pro·tec·tant/ (pro-tek´tant) protective. protectant, protective 1. affording defense or immunity. 2. an agent affording defense against harmful influence. against hearing loss in children receiving platinum-based chemotherapy. - Advance the lead candidate from our small molecule N-cadherin antagonist program through preclinical development and toxicology studies required for the preparation of an Investigational New Drug (IND) application with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. . - Selectively monetize our non-cancer cadherin-based intellectual property to provide potential sources of non-dilutive funding for the Company. Key accomplishments for Adherex in 2005 included: - Entering into a license and development agreement with GlaxoSmithKline (GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) ) covering two drugs, eniluracil and ADH-1. The agreement includes the in-license of GSK's oncology product, eniluracil, by Adherex and an option for GSK to license Adherex's lead biotechnology compound, ADH-1 (Exherin(TM)). - Closing an $8.5 million private placement in July 2005, which included a $3 million investment by GSK. - Initiating three single agent trials of ADH-1: a Phase II trial in Canada examining every three week dosing; a Phase Ib/II trial in Europe examining weekly dosing; and a Phase Ib/II trial in the U.S. examining daily dosing (Monday through Friday) every three weeks. - Presenting the Company's global development plans for eniluracil, including data which indicates that the dose, dose ratio, and schedule of administering eniluracil and 5-FU are critical to achieving the optimal therapeutic effectiveness of the combination. - Receiving IND clearance from the FDA, enabling Adherex to commence U.S.-based clinical trials of eniluracil. - Receiving Orphan Drug Designation from the FDA for the use of eniluracil in combination with fluoropyrimidines (including 5-FU) for the treatment of hepatocellular cancer. - Presenting clinical data on its Phase I trial of ADH-1 at the 2005 ASCO Annual Meeting indicating that ADH-1 was well tolerated and showed evidence of anti-tumor activity in three patients with advanced chemotherapy resistant cancer; one of these patients achieving a rapid and durable partial response, defined as a reduction of at least 50% in tumor size. Subsequently, the Company has reported evidence of anti-tumor activity in two additional patients in its Phase I experience, for a total of five patients. About Adherex Technologies Adherex Technologies Inc. is a biopharmaceutical company dedicated to the discovery and development of novel cancer therapeutics. We aim to be a leader in developing innovative treatments that address important unmet medical needs in cancer. We currently have multiple products in the clinical stage of development, including ADH-1 (Exherin(TM)), eniluracil and sodium thiosulfate sodium thiosulfate, Na2S2O3, colorless crystalline compound that is more familiar as the pentahydrate, Na2S2O3·5H2 (STS). ADH-1, our lead biotechnology compound, selectively targets N-cadherin, a protein present on certain tumor cells and established blood vessels Blood vessels Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names. that feed solid tumors. Eniluracil, an oral dihydropyrimidine dehydrogenase (DPD) inhibitor, was previously under development by GlaxoSmithKline for oncology indications. STS, a drug from our specialty pharmaceuticals pipeline, protects against the disabling hearing loss that can often result from treatment with platinum-based chemotherapy drugs. With a diversified portfolio of unique preclinical and clinical-stage cancer compounds and a management team with expertise in identifying, developing and commercializing novel cancer therapeutics, Adherex is emerging as a pioneering oncology company. For more information, please visit our website at www.adherex.com. This press release contains forward-looking statements that involve significant risks and uncertainties. The actual results, performance or achievements of the Company might differ materially from the results, performance or achievements of the Company expressed or implied by such forward-looking statements. Such forward-looking statements include, without limitation, those regarding the development plans of the Company and the expected timing and results of such development. We can provide no assurance that such development will proceed as currently anticipated or that the expected timing or results of such development will be realized. We are subject to various risks, including those inherent in the biopharmaceutical industry, the early stage of our product candidates, the uncertainties of drug development, clinical trials and regulatory review, our reliance on collaborative partners, our need for additional capital to fund our operations, and our history of losses. For a more detailed discussion of related risk factors, please refer to our public filings available at www.sedar.com and www.sec.gov. Adherex Technologies Inc. (TSX:AHX) (AMEX:ADH) |
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