Progenics Pharmaceuticals Announces Completion of Enrollment of Chemotherapy
Experienced Cohort in Phase II PSMA ADC Clinical Trial in Prostate Cancer
– Top-line Data in Chemotherapy Experienced Patients to be Presented at
Oncology Meeting in January 2014
–Additional Cohort in Chemotherapy Naive Patients Has Been Added to the
TARRYTOWN, N.Y., Dec. 6, 2013 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals,
Inc., (Nasdaq:PGNX) an oncology company focused on developing innovative
approaches to targeting and treating prostate cancer, today announced that it
has completed enrollment of chemotherapy experienced patients in a Phase II
trial to assess the anti-tumor activity and tolerability of its antibody drug
conjugate, PSMA ADC in patients with metastatic castrate resistant prostate
cancer (mCRPC). A total of 83 patients who had progressive disease despite
treatment with at least one taxane containing chemotherapy received PSMA ADC.
Based on the observations following treatment of the patients in the
chemotherapy experienced cohort, Progenics has initiated treatment of a cohort
of chemotherapy naive patients who have progressed on hormonal therapies.This
cohort is now enrolling.Progenics expects that an additional 35 patients will
be included in this chemotherapy naïve group.
"PSMA ADC is the most advanced antibody drug conjugate in clinical development
to treat prostate cancer," said Robert J. Israel, M.D., Executive Vice
President, Medical Affairs."Based on the data seen with PSMA ADC in
chemotherapy experienced patients, we have decided to explore whether this
compound can also benefit men in the less clinically advanced chemotherapy
Topline data on the chemotherapy experienced cohort of the Phase II PSMA ADC
trial will be presented at the American Society of Clinical Oncology's 2014
Genitourinary Cancers Symposium Meeting in San Francisco in January 2014.
About PSMA ADC
Prostate Specific Membrane Antigen, PSMA, a protein that is a validated
biomarker of prostate cancer, is expressed on the surface of prostate cancer
cells as well as on blood vessels supplying other solid tumors.PSMA ADC
comprises a fully human monoclonal antibody selectively targeting PSMA linked
to a chemotherapeutic drug.Using technology licensed from Seattle Genetics,
Inc., the PSMA antibody is linked to monomethyl auristatin E, a compound that
inhibits cell proliferation by disrupting the cellular "backbone" (i.e.
microtubules) required for replication.The resultant antibody-drug conjugate
attaches to the PSMA protein on the surface of prostate cancer cells and is
designed to internalize into the cancer cell, release active anti-cancer drug,
and destroy the malignant cell.
Unlike traditional chemotherapy, PSMA ADC is designed to deliver the drug
selectively to prostate cancer cells by targeting PSMA.
About Prostate Cancer
Prostate cancer is the second most common form of cancer affecting men in the
United States: an estimated one in six will be diagnosed with prostate cancer
in his lifetime.The American Cancer Society estimates that approximately
240,000 new cases of prostate cancer will be diagnosed and about 30,000 men
will die of the disease this year, and that approximately 2 million men in the
U.S. currently count themselves among prostate cancer survivors.
Progenics Pharmaceuticals, Inc. is developing innovative medicines for
oncology, with a pipeline that includes several product candidates in
late-stage clinical development. Progenics' first-in-class PSMA targeted
technology platform includes an antibody drug conjugate therapeutic and a
small molecule targeted imaging agent, both completing phase 2 clinical
trials. Among other assets in its pipeline of targeted radiotherapy and
molecular imaging compounds is Azedra^™, an ultra-orphan radiotherapy
candidate in a registrational phase 2 study under an SPA with the FDA.
Progenics' first commercial product, Relistor^® (methylnaltrexone bromide) for
opioid-induced constipation, is partnered with and marketed by Salix
Pharmaceuticals, Inc. Ono Pharmaceutical Co. has licensed subcutaneous
Relistor in Japan. For additional information, please visit www.progenics.com.
This press release may contain projections and other forward-looking
statements regarding future events. Such statements are predictions only, and
are subject to risks and uncertainties that could cause actual events or
results to differ materially. These risks and uncertainties include, among
others, the cost, timing and results of clinical trials and other development
activities; the unpredictability of the duration and results of regulatory
review of New Drug Applications and Investigational NDAs; market acceptance
for approved products; generic and other competition; the possible impairment
of, inability to obtain and costs of obtaining intellectual property rights;
and possible safety or efficacy concerns, general business, financial and
accounting matters, litigation and other risks. More information concerning
Progenics and such risks and uncertainties is available on its website, and in
its press releases and reports it files with the U.S. Securities and Exchange
Commission. Progenics is providing the information in this press release as of
its date and does not undertake any obligation to update or revise it, whether
as a result of new information, future events or circumstances or otherwise.
Additional information concerning Progenics and its business may be available
in press releases or other public announcements and public filings made after
Information on or accessed through our website is not included in the
company's SEC filings.
For more information, please visit www.progenics.com.
CONTACT: Kathleen Fredriksen
Press spacebar to pause and continue. Press esc to stop.