Lets follow that last post with the latest positive PRnews...mch
Friday June 19, 7:30 am Eastern Time
Company Press Release
SOURCE: Progenics Pharmaceuticals, Inc.
Progenics Reports Progress in Lead Cancer and HIV
Programs
- Promising Results Presented at Two International Scientific Conferences -
TARRYTOWN, N.Y., June 19 /PRNewswire/ -- Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX
- news) reported new developments in the Company's lead cancer and HIV programs in scientific
presentations this week in Amsterdam and New York City.
At the 10th NCI-EORTC Symposium on New Drugs in Cancer Therapy held in Amsterdam,
Progenics' lead cancer vaccine, GMK, was reported to induce antibodies in vaccinated patients that
potently killed cancer cells. Robert J. Israel, M.D., Progenics' Vice President, Medical Affairs,
presented results of a study of 52 malignant melanoma patients who received the GMK vaccine in
Phase I/II clinical trials at Memorial Sloan-Kettering Cancer Center. Greater than 95 percent of
vaccinated patients produced anti-GM2 antibodies which potently killed melanoma cells in an in vitro
assay of complement- mediated cytotoxicity. In addition, Dr. Israel reported that there were no
significant side effects in patients receiving the GMK vaccine. Progenics is collaborating with
Bristol-Myers Squibb Company (NYSE: BMY - news) in the development of GMK and has
granted to Bristol-Myers Squibb an exclusive worldwide license to commercialize the vaccine.
The GMK vaccine is designed to stimulate a patient's immune system to control or eradicate residual
cancer cells by inducing antibodies to GM2 ganglioside, a cancer antigen present in approximately 95
percent of melanoma cells. It has been found that patients with high risk melanoma who develop
antibodies against GM2 remain disease free for significantly longer periods and have improved
overall survival. GMK is currently in pivotal Phase III clinical trials in the U.S. for high risk melanoma
patients. A second pivotal Phase III trial of GMK for high risk melanoma is currently ongoing and
will be conducted in New Zealand, Australia, South America, South Africa, and Europe. A third
pivotal Phase III trial for intermediate risk melanoma patients in Europe is expected to commence in
1998. There are an estimated 300,000 people in the U.S. with melanoma, the most deadly form of
skin cancer.
New clinical findings on Progenics' lead HIV therapeutic, PRO 542, were presented at the Bio '98
International Biotechnology Meeting in New York City. PRO 542 is currently in Phase I/II clinical
trials in HIV-positive adults and children. William C. Olson, Ph.D., Progenics' Director of Research
and Development, presented preliminary results of the dose-escalating studies which indicate that
PRO 542 was well-tolerated at the two dose levels examined to date. Encouragingly, peak serum
concentrations of PRO 542 were proportional to the injected dose and significant levels were
detected for two weeks post-injection. Patients achieved and sustained drug levels previously shown
to neutralize clinical strains of HIV in vitro. The studies continue to enroll patients at higher dose
levels. The Phase I/II study in HIV-positive adults is being conducted at Mount Sinai Medical Center
in New York City. A second multicenter clinical trial is underway in HIV-positive children under the
sponsorship of the AIDS Clinical Trials Group (ACTG) of the National Institute of Allergy and
Infectious Diseases (NIAID). Both trials will measure safety, pharmacokinetics, immunogenicity and
antiviral activity of PRO 542.
PRO 542 is a novel fusion protein that incorporates the HIV-binding region of the human cell surface
receptor into a human antibody molecule. PRO 542 is designed to neutralize HIV by two
mechanisms: binding to the gp120 glycoprotein on the HIV envelope, thereby preventing the virus
from binding to the cell surface; and, binding to and detaching the gp120 glycoprotein from the HIV
envelope, thereby inactivating the virus. PRO 542 has been shown in preclinical studies to potently
neutralize a wide range of HIV strains from all geographic regions. In an animal model of HIV
infection, PRO 542 protected against infection by strains of the virus isolated from HIV-infected
individuals. Progenics has a collaboration with Genzyme Transgenics Corporation [Nasdaq:GZTC -
news] to produce PRO 542 in the milk of transgenic animals.
Progenics Pharmaceuticals, Inc. is a biopharmaceutical company focusing on the development and
commercialization of innovative products for the treatment and prevention of cancer and viral
diseases. The Company's lead product, GMK, is a cancer vaccine in pivotal Phase III clinical trials
for the treatment of malignant melanoma. A second cancer vaccine, MGV, with broad application to
a variety of cancers, is in Phase I/II trials. Progenics has a collaboration with Bristol-Myers Squibb
Company in the area of cancer vaccines. Progenics' lead HIV product, PRO 542, is in Phase I/II
clinical trials, and a follow-on HIV product, PRO 367, is expected to commence Phase I/II trials in
1998. Progenics also has a collaboration with F. Hoffmann-La Roche Ltd. in the area of HIV
therapeutics which target fusion co-receptors.
This news release contains forward-looking statements that involve risks and uncertainties. The
Company's actual results may differ materially from those anticipated in these forward-looking
statements. Factors that may cause such differences include, but are not limited to, those discussed in
the Company's Annual Report on Form 10-K for the year ended December 31, 1997, as filed with
the Securities and Exchange Commission, including the uncertainties associated with product
development, the risk that clinical trials will not commence when planned, the risks and uncertainties
associated with dependence upon the actions of government regulatory agencies and the risk that
products that appeared promising in early clinical trials do not demonstrate efficacy in larger-scale
clinical trials. In particular, there can be no assurance that the Company's cancer and HIV programs,
in general, and the GMK vaccine and PRO 542, in particular, will result in the commercialization of a
product.
SOURCE: Progenics Pharmaceuticals, Inc.
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