Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
PRNewswire - June 12, 2000
In this ongoing Phase I/II trial, antiretroviral naive patients were randomized to receive DMP-450 or indinavir in combination with stavudine and lamivudine. Forty patients received DMP-450 at doses of either 750mg three times a day, 1250mg three times a day or 1250mg twice a day. Ten patients received indinavir at the approved dose of 800mg three times a day. During the course of this 24-week trial, the majority of patients in all groups had their viral load suppressed to undetectable levels (less than 400 copies/mL). Preliminary data from this study indicate that DMP-450 is generally well tolerated and no significant laboratory toxicities have been observed. Week 24 data show that patients receiving DMP-450 had less increase in total serum cholesterol than those receiving indinavir.
"DMP-450 has shown promising antiviral activity and a favorable tolerability profile in this Phase I/II study. I think this is particularly significant in that DMP-450 has a chemical structure different from all other marketed protease inhibitors and is easily synthesized and formulated. We remain committed to this drug candidate, and following completion of this study and a full analysis of the data, plan to initiate discussions with the FDA concerning its future development in the United States, where DMP-450 has been placed on partial clinical hold," said David W. Barry, M.D., Chairman and Chief Executive Officer of Triangle Pharmaceuticals, Inc.
Triangle Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the development of new antiviral drug candidates, with a particular focus on therapies for the human immunodeficiency virus (HIV), including the acquired immunodeficiency syndrome (AIDS), the hepatitis B virus (HBV) and hepatitis C virus (HCV). Triangle's proprietary drug candidates under development for HIV and/or HBV include Coviracil (R) (emtricitabine), Coactinon(R) (emivirine), DAPD, L-FMAU (clevudine) and DMP-450. Triangle is also developing immunotherapies for HIV, HBV and HCV in collaboration with Dynavax Technologies Corporation (Dynavax) utilizing Dynavax' immunostimulatory sequence (ISS) technology. More information about Triangle's portfolio, management and product development strategy is available on Triangle's website at: http://www.tripharm.com.
Statements in this press release that are not historical facts are forward-looking statements and are subject to numerous risks and uncertainties, including the risk that the Company could fail to successfully complete pivotal clinical trials or that such trials could be halted or terminated by regulatory authorities, whether the FDA will remove the partial clinical hold placed on DMP-450 so that the Company may initiate potential efficacy studies in the U.S., the Company's future capital needs, the inability to commercialize Coviracil, DAPD and ISS-based therapies due to patent rights held by third parties, the Company's ability to obtain additional funding (including contingent contractual milestone payments), patent protection and required regulatory approvals for its drug candidates, the development of competitive products by others, the cost of coactive therapy and the extent to which coactive therapy achieves market acceptance, the Company's success in identifying new drug candidates, acquiring rights to the candidates on favorable terms and developing any candidates to which the Company acquires any rights, that the Company's collaborations with third parties may not prove successful and these and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. As a result of these and other risks and uncertainties, actual results may differ materially from those predicted in this press release. The Company disclaims any obligations to update any forward-looking statements in this press release.
SOURCE Triangle Pharmaceuticals, Inc.
Contact: Carolyn Underwood, Executive Vice President, Commercial Operations of Triangle Pharmaceuticals, Inc., 919-493-5980, or Douglas MacDougall or Kari Lampka of Feinstein Kean Healthcare, 617-577-8110/
Web Site: http://www.fkhealth.com/
Web Site: http://www.tripharm.com/
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