Monogram Biosciences Provides Progenics Pharmaceuticals with HIV Assays for Use in Clinical Trials
April 01 2008 - 6:00AM
PR Newswire (US)
Trofile to be used to screen patients for clinical program of
monoclonal antibody to CCR5 SOUTH SAN FRANCISCO, Calif., April 1,
2008 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc.,
(NASDAQ:MGRM) 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) 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) 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) 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. About
Monogram 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. Trofile and
Phenosense GT are trademarks of Monogram Biosciences, Inc.
contacts: Alfred G. Merriweather Jeremiah Hall Chief Financial
Officer Feinstein Kean Healthcare Tel: 650 624-4576 Tel: 415
677-2700 amerriweather@ jeremiah.hall@ monogrambio.com fkhealth.com
DATASOURCE: Monogram Biosciences, Inc. CONTACT: Alfred G.
Merriweather, Chief Financial Officer of Monogram Biosciences,
Inc., +1-650-624-4576, ; or Jeremiah Hall of Feinstein Kean
Healthcare, +1-415-677-2700, Web site: http://www.monogrambio.com/
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