| May 09, 2001 |
| Hemispherx Biopharma, LabCorp® combine forces for Nationwide testing in HIV Immunotherapy Clinical Trials |
Philadelphia, PA, Wednesday, May 09, 2001: Hemispherx Biopharma, Inc. (AMEX: HEB; HEBws) announced today that it has entered into a contractual relationship with the clinical trials testing division of Laboratory Corporation of America® Holdings (LabCorp®; NYSE: LH) to provide nationwide laboratory testing, including HIV plasma levels for its two recently authorized immunotherapy clinical trials.
The two authorized HIV treatment protocols, designated REARM 1 and REARM 2, address two central questions in AIDS clinical research today – whether antiviral activity against mutated HIV can be improved by novel additions to currently approved drug regimens and whether immune reconstitution can occur in this therapeutic setting. LabCorp will perform safety testing, as well as HIV molecular testing, including genotyping using LabCorp’s HIV GENOSURE™. Hemispherx said that collection kits from LabCorp are being delivered this week to clinical sites, which have received IRB approvals and are ready to proceed.
In choosing LabCorp for its nationwide program in innovative potential HIV treatments, Hemispherx said it considered LabCorp's expertise and the longstanding corporate relationship. LabCorp is a leader in HIV testing services and provides innovative diagnostic technology which ensures accurate, ultrasensitive measurements of HIV. LabCorp also provides uniform nationwide standards, seamless logistics and a strong technical back drop in support of advanced Phase IIb, as well as Phase I – IV, protocols. Proprietary innovative specimen tracking software programs are designed to complement continuous QA/QC capabilities at a high international regulatory compliance level.
Hemispherx is a globally-operating biopharmaceutical company engaged in the manufacture and worldwide clinical development of new drug entities in the nucleic acid (NA) class for viral diseases and disorders of the immune system designed to mitigate the skyrocketing costs of long-term medical care for the chronically ill. Its flagship investigational products are being aggressively pursued with respect to potential applicability to CFS, multi-drug-resistant HIV/AIDS and hepatitis.
Based in Raritan, N.J., LabCorp's clinical trials division is a leading central laboratory supporting global pharmaceutical, biotechnology and medical device clinical trials with method development and a broad menu of safety and efficacy testing from drug discovery through Phase IV.
Headquartered in Burlington, N.C., Laboratory Corporation of America Holdings is a national clinical laboratory organization, which operates facilities for conducting clinical assays and diagnostic testing throughout the U.S. The company had 2000 revenues of $1.9 billion and employs approximately 18,000.
Contact(s):
William Carter, M.D., CEO and Chairman, Hemispherx Biopharma, Inc.
(215) 988-0080, (215) 988-1739 (FAX);
Amy McGrath, Worldwide Marketing Manager, LabCorp Clinical Trials
(908) 526-2400;
Pam Sherry, LabCorp Investor Relations (336) 436-4855;
Dianne Will, Investor Relations, Hemispherx Biopharma, Inc.
(518) 398-6222, Fax: (518) 398-6223.
HEB’s Web Site: www.hemispherx.net
Information contained in this news release other than historical information, including the referenced protocols REARM 1 and REARM 2, should all be considered forward-looking and are subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risks of competition, changing market conditions, changes in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Accordingly, actual results may differ materially from those in any forward looking statements. Additionally, all the referenced investigational drugs and associated technologies of the company are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgement as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.
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