Monogram Biosciences Provides Progenics Pharmaceuticals with HIV Assays for Use in Clinical Trials
SOUTH SAN FRANCISCO, Calif., April 1, 2008, 2008 -- Monogram Biosciences announced today that it had entered into an agreement with Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) to provide resistance and tropism testing for Progenics' clinical development program of PRO 140, an investigational CCR5 monoclonal antibody being studied for the treatment of HIV. In its ongoing phase 2 studies, Progenics is using Monogram's Trofile(TM: 103.10, +2.21, +2.19%) tropism test to screen and monitor HIV infected individuals whose virus uses the CCR5 receptor as a portal of entry to healthy cells. Progenics is also using Monogram's PhenoSense GT(TM: 103.10, +2.21, +2.19%) assay to measure viral resistance to drugs from other HIV-1 treatment classes.
"We are pleased to play such an important role in the development of this promising new HIV therapy," said Chris Petropoulos, Monogram's Chief Scientific Officer. "Monogram continues to help pave the path for many of the most highly anticipated new HIV drugs in development."
Trofile is a patient selection co-receptor tropism assay that determines whether a patient is infected with a strain of HIV that uses the CCR5 co- receptor, the CXCR4 co-receptor, or a combination of CCR5 and CXCR4 to enter cells. Trofile is the only clinically validated tropism assay and has been used to select patients in all phase 2 and phase 3 studies of CCR5 antagonists to date.
About PRO 140
Progenics announced the start of the phase 2 program for PRO 140 in January 2008. PRO 140 is a novel monoclonal antibody that binds CCR5 and is designed to prevent HIV from entering immune system cells and thereby prevent viral replication, which occurs within the cells. CCR5 is also a receptor for chemokines, members of a family of protein molecules that are secreted by cells as part of the body's natural inflammatory response. Unlike small- molecule CCR5 antagonists, PRO 140 inhibits HIV entry at concentrations that in vitro do not appear to block CCR5's natural function, which includes, in part, directing the migration of immune cells towards sites of inflammation in the body.
About Progenics Pharmaceuticals, Inc.
Progenics Pharmaceuticals, Inc., of Tarrytown, NY, is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. Principal programs are directed toward gastroenterology as well as the treatment of HIV infection and cancer. The Company, in collaboration with Wyeth, is developing methylnaltrexone for the treatment of opioid-induced side effects, including constipation (oral and subcutaneous formulations) and post-operative ileus (intravenous formulation). In March 2007, the Company submitted a New Drug Application to the United States Food and Drug Administration for the subcutaneous formulation of methylnaltrexone for patients suffering from opioid-induced constipation while receiving palliative care, followed in May 2007 by Wyeth's submission of a Marketing Authorization Application (MAA: 52.26, +2.42, +4.85%) in Europe to the European Medicines Agency (EMEA). In the area of HIV infection, the Company is developing the viral-entry inhibitor PRO 140, a humanized monoclonal antibody targeting the HIV entry co-receptor CCR5, which has completed phase 1b clinical studies with positive results. In the area of prostate cancer, the Company is developing a human monoclonal antibody drug conjugate -- a selectively targeted cytotoxic antibody directed against prostate-specific membrane antigen (PSMA), a protein found on the surface of prostate cancer cells. Progenics is also developing vaccines designed to stimulate an immune response to PSMA.
Monogram is a biotechnology company 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 are forward-looking. These forward-looking statements include references to the demand for our testing products, including our Trofile Assay, the potential use of our Trofile Assay for patient selection for the class of HIV drugs known as CCR5 antagonists, the size and timing of Progenics' clinical trials utilizing our products, the outlook for Progenics' investigational drug mentioned in this release and for our testing products, expected protection provided by patents, possible regulation of our products by the FDA. 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: the risk that physicians may not use a molecular diagnostic for patient selection for CCR5 antagonists or other HIV drugs; whether larger confirmatory clinical studies will confirm the results of initial studies; risks and uncertainties relating to the performance of our products; the growth in revenues; the size, timing and success or failure of any clinical trials for HIV drugs, such as Progenics' drug mentioned in this release; the risk that our Trofile Assay may not be utilized for patient use with CCR5 inhibitors; our ability to successfully conduct clinical studies and the results obtained from those 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 payers will authorize reimbursement for our products and services and the amount of such reimbursement that may be allowed; whether the FDA or any other agency will decide to further regulate our products or services, including Trofile; whether the draft guidance on Multivariate Index Assays issued by FDA will be subsequently determined to apply to our current or planned products; 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; restrictions on the conduct of our business imposed by the Pfizer, Merrill Lynch and other debt agreements; the impact of additional dilution if our convertible debt is converted to equity; and whether we will be able to raise sufficient capital in the future, if required. For a discussion of other factors that may cause 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.