Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Monday September 29 8:29 AM EDT
To date over 40 HIV infected asymptomatic volunteers have been treated in an ongoing Phase I/II double-blind, randomized, placebo-controlled study designed to evaluate the safety, efficacy and pharmacokinetic profiles of repeated multiple oral doses of MKC-442. Patients received treatment of MKC- 442 for up to two months with doses ranging from 100 mg to 750 mg twice daily.
MKC-442 continues to demonstrate improved antiviral activity as the dose studied is increased. In the highest dose regimen reported, 750 mg twice-a- day, all patients had greater than a 90% decrease in the amount of HIV in the blood (median=96% or 1.5 log decrease) after one week of treatment with MKC- 442 alone. These decreases were followed by a gradual increase in viral load toward original levels over the next month as is typical of drugs of this class when used as monotherapy. A genetic mutation in HIV-1 RT at residue 103, which may be associated with resistance to MKC-442, has been observed in the virus recovered from several of the patients, also consistent with observations from patients on other NNRTI monotherapy regimens. Further dose escalation of MKC-442 is ongoing to define the optimal dose to be taken forward into pivotal combination trials.
The Company also reported that MKC-442 is metabolized by the same cytochrome P450 enzymes which are responsible for the metabolism of other NNRTIs as well as protease inhibitors. In over 300 patient-weeks of exposure to MKC-442, the drug has been generally well tolerated and the only clinically significant adverse reaction observed has been a moderate rash in two patients.
"We continue to be encouraged by the efficacy and safety profile of MKC- 442 and are moving towards the initiation of pivotal trials this fall where it will be evaluated in combination with other antiretrovirals for more complete control of this infection," said David W. Barry, M.D., Chairman and Chief Executive Officer of Triangle Pharmaceuticals. "While MKC-442 is the farthest along in development of our drug candidates, we are also pleased by the progress of our other anti-HIV compounds. We expect to have a total of four anti-HIV compounds in the clinic by the end of the year and a fifth compound in the clinic in the first half of 1998."
Triangle Pharmaceuticals, Inc., based in Durham, North Carolina, is engaged in the development of new drug candidates primarily in the antiviral area, with a particular focus on therapies for the human immunodeficiency virus, including the acquired immunodeficiency syndrome, and hepatitis B virus. Prior to their employment with the Company, members of the Company's management team played instrumental roles in the identification, clinical development and commercialization of several leading antiviral therapies. For more information about Triangle, visit the Triangle Pharmaceuticals' website at: http://www.tripharm.com
Statements in this press release may constitute forward-looking statements and are subject to numerous risks and uncertainties, including the failure to successfully complete pivotal clinical trials, the Company's future capital needs, the Company's ability to obtain additional funding and required regulatory approvals, the development of competitive products by others, and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. The actual results may differ materially from those contained in this press release. The Company disclaims any obligation to update the statements in this press release.
SOURCE Triangle Pharmaceuticals, Inc.
Copyright (c) 1997/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.
970929
PR970926
Copyright © 1997 - PRNewswire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through PRNewswire, Permissions, 810 Seventh Ave., 32nd Floor, New York, NY 10019 http://www.prnewswire.com.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, National Library of Medicine, and donations from users like you.
Always watch for outdated information. This article first appeared in 1997. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 1997. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .