SOUTH SAN FRANCISCO, Calif., Feb. 21 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. announced today that it is collaborating with Merck & Co., Inc. by providing its PhenoSense and GeneSeq testing technologies for use in Phase III trials of MK-0518, Merck’s investigational HIV-1 integrase inhibitor. MK-0518 is a novel compound with the potential to be the first in a new class of anti-retroviral drugs for the treatment of HIV/AIDS. Integrase inhibitors are designed to block HIV from replicating by preventing the viral enzyme integrase from inserting HIV DNA into the human genome.
“We are very pleased to be initiating our Phase III program for MK-0518,” said Daria Hazuda, vice president of Virus and Cell Biology, Merck Research Laboratories. “We have chosen to collaborate with Monogram Biosciences for HIV phenotypic and genotypic testing because of their expertise in developing technologies critical for optimizing patient therapy and evaluating drug resistance.”
Drug resistance will be evaluated using Monogram’s PhenoSense GT, as well as other phenotypic and genotypic assays and clinical trial services. The MK- 0518 study joins Monogram’s extensive portfolio of drug development testing for new and promising classes of HIV antiretroviral therapies.
“Merck and Monogram have been close collaborators in HIV resistance for many years and we are very happy to again be supporting the clinical development of a potentially important new HIV therapy,” said Monogram Chief Scientific Officer Christos J. Petropoulos. “The manner in which Merck is applying our tests is exactly as we intended, initially for the evaluation of new drug classes and subsequently for optimizing treatment regimens.”
MK-0518 entered Phase III development early this year. The Phase III studies will take place at study sites in North America, Central America, South America, Europe, Australia and Asia.
About Monogram Biosciences, Inc.
Monogram is advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious diseases and cancer. The Company’s products are designed to help doctors optimize treatment regimens for their patients that lead to better outcomes and reduced costs. The Company’s technology is also being used by numerous biopharmaceutical companies to develop new and improved antiviral therapeutics and vaccines as well as targeted cancer therapeutics. More information about the Company and its technology can be found on its web site at http://www.monogrambio.com.
Forward-Looking Statements
Certain statements in this press release and attached supplemental information are forward-looking. These forward-looking statements include references to the potential use for the Company’s tests with new classes of HIV drugs. These forward-looking statements are subject to risks and uncertainties and other factors, which may cause actual results to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties relating to the performance of our products; the growth in revenues; the size, timing and success or failure of clinical trials for new classes of HIV drugs; the use of our tests for patient use in the event of approval of any new drugs; our ability to successfully conduct clinical studies and the results obtained from those studies; whether larger confirmatory clinical studies will confirm the results of initial studies; our ability to establish reliable, high-volume operations at commercially reasonable costs; expected reliance on a few customers for the majority of our revenues; the annual renewal of certain customer agreements; actual market acceptance of our products and adoption of our technological approach and products by pharmaceutical and biotechnology companies; our estimate of the size of our markets; our estimates of the levels of demand for our products; the impact of competition; the timing and ultimate size of pharmaceutical company clinical trials; whether payors will authorize reimbursement for our products and services; whether the FDA or any other agency will decide to further regulate our products or services; whether we will encounter problems or delays in automating our processes; the ultimate validity and enforceability of our patent applications and patents; the possible infringement of the intellectual property of others; whether licenses to third party technology will be available; whether we are able to build brand loyalty and expand revenues; the potential impact of cash and/or stock payments by us on the Contingent Value Rights issued to shareholders of ACLARA; and whether we will be able to raise sufficient capital if required. For a discussion of other factors that may cause our actual events to differ from those projected, please refer to our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. We do not undertake, and specifically disclaim any obligation, to revise any forward-looking statements to reflect the occurrence of anticipated or unanticipated events or circumstances after the date of such statements.
PhenoSense is a trademark of Monogram Biosciences, Inc. Press Release contacts: Alfred G. Merriweather Jeremiah Hall Chief Financial Officer Feinstein Kean Healthcare Tel: 650 624 4576 Tel: 415 677-2700 amerriweather@monogrambio.comjeremiah.hall@fkhealth.com
Monogram Biosciences, Inc.
CONTACT: Alfred G. Merriweather, Chief Financial Officer of MonogramBiosciences, Inc., +1-650-624-4576, amerriweather@monogrambio.com; orJeremiah Hall of Feinstein Kean Healthcare, +1-415-677-2700,jeremiah.hall@fkhealth.com
Web site: http://www.monogrambio.com/
