Progenics Pharmaceuticals' Novel Small Molecule Drugs Targeting PSMA Successfully Visualize Prostate Cancer

Progenics Pharmaceuticals' Novel Small Molecule Drugs Targeting PSMA
Successfully Visualize Prostate Cancer

        — Positive Data Reported in The Journal of Nuclear Medicine —

    — Global Phase 2 Imaging Trial of Next Generation Molecule Underway —

TARRYTOWN, N.Y., March 5, 2013 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals,
Inc. (Nasdaq:PGNX) reported positive clinical data from a study of two novel
radiolabeled small molecules targeting prostate-specific membrane antigen
(PSMA). The imaging agents — ^123I-MIP-1072 and ^123I-MIP-1095 — had a high
sensitivity of lesion detection in bone, tissue and the prostate gland with
minimal retention in non-target tissue. The research was published as the
cover article in the March issue of The Journal of Nuclear Medicine.

"Existing imaging techniques are limited in their ability to diagnose and
stage prostate cancer," said John J. Babich, Ph.D., senior author of the
article "First-in-Man Evaluation of Two High-Affinity PSMA-Avid Small
Molecules for Imaging Prostate Cancer." "The approach described in this paper
has the potential to assess disease status more accurately. It could help
clinicians select optimal treatments and lead to better patient outcomes."

Separate phase 1 studies were conducted under an exploratory investigational
new drug (IND) application to measure the potential effectiveness of the small
molecules in diagnosing and staging prostate cancer. In the first study, seven
patients with documented prostate cancer were administered doses of
^123I-MIP-1072 and ^123I-MIP-1095, two weeks apart. In the second study, six
healthy volunteers received ^123I-MIP-1072 only. Whole body planar imaging and
single photon emission computed tomography (SPECT)/computed tomography (CT)
were performed for each group, and pharmacokinetics, tissue distribution,
excretion, safety and organ radiation dose were analyzed.

Based on the data reported, Progenics is conductinga global, multi-center
phase 2 trial investigating a next generation radiolabeled small molecule
targeting PSMA, MIP-1404.

Mark R. Baker, chief executive officer of Progenics, said, "We recently
acquired all of the rights to the compounds described in this Journal of
Nuclear Medicine paper, as well as to the phase 2 stage imaging agent
MIP-1404, through Progenics' acquisition of Molecular Insight Pharmaceuticals.
It is gratifying to see this expansion of our oncology pipeline demonstrating
progress so soon."

Robert J. Israel, M.D., Progenics' senior vice president of medical affairs
and clinical research, said, "We believe that MIP-1404 has excellent potential
as a diagnostic radiopharmaceutical. Results to date from the study compounds
and MIP-1404 show PSMA as a robust target for prostate cancer molecular
imaging, and that a radiolabeled small molecule, which binds PSMA with high
affinity, has the potential to detect prostate cancer throughout the body.
Cancer treatment guidelines call for imaging prostate cancer with conventional
bone scans or MRI. A more accurate method of imaging prostate cancer could be
of great value."

Mr. Baker further added, "Thought leaders in prostate cancer care are focused
on avoiding unnecessary surgery and other invasive procedures due to the
complications associated with them. Clinicians generally prefer "watchful
waiting" when the cancer appears to be indolent. At the same time, some
therapeutics to treat aggressive prostate cancer have recently been approved
or are under development, such as Progenics' own PSMA ADC, which currently is
in phase 2 testing. Patients and their physicians would benefit from feedback
on how therapeutic agents are impacting the course of cancer, and guidance on
how and when to use therapeutic agents. It is clear that an improved way to
visualize prostate cancer, with a high degree of specificity and sensitivity,
would better inform both "watchful waiting" and the treatment of aggressive
disease. We believe that data from the ongoing phase 2 trial of MIP-1404 will
demonstrate its capabilities to assist prostate cancer patients and their
physicians in making these critical decisions."

About Prostate Cancer

Prostate cancer is the most common form of cancer affecting men in the United
States and is the second leading cause of cancer deaths among men each year.
The American Cancer Society estimates that in 2013, 238,590 new cases of
prostate cancer will be diagnosed and approximately 29,720 American men will
die from the disease. Accurate diagnosis and staging of prostate cancer is
critical to determining appropriate patient management.

About Progenics

Progenics Pharmaceuticals, Inc. is discovering and developing innovative
medicines for oncology, with a pipeline that includes product candidates in
preclinical through late-stage development. Progenics' first commercial
product, Relistor^® (methylnaltrexone bromide) for opioid-induced
constipation, is marketed and in further development by Salix Pharmaceuticals,
Ltd. for markets worldwide other than Japan, where Ono Pharmaceutical Co.,
Ltd. holds an exclusive license for the subcutaneous formulation. For
additional information, please visit

The Progenics Pharmaceuticals Inc. logo is available at

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
this release.


CONTACT: Kathleen Fredriksen
         Corporate Development
         (914) 789-2871

company logo
Press spacebar to pause and continue. Press esc to stop.