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PROGENICS
SELECTS SUBCUTANEOUS FORM OF PRO 140,


A
NOVEL HIV ANTIBODY THERAPY,


FOR
FURTHER DEVELOPMENT




—
Positive phase 2 clinical results showed PRO 140 demonstrated potent activity,
favorable tolerability and the convenience of potential weekly
self-administration —




Montreal, Quebec and Tarrytown,
NY – February 10, 2009 – Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX)
today announced that it has selected for further development the subcutaneous
form of PRO 140 for the treatment of HIV infection.  The decision
follows positive results from a recently completed phase 2 clinical trial as
well as feedback from key opinion leaders, treatment advocates and people living
with HIV. Results from the phase 2 study were presented late yesterday at the
16th
Conference on Retroviruses and
Opportunistic Infections(CROI) in Montreal. In this clinical trial, the
subcutaneous dosage form of PRO 140 demonstrated potent and highly significant
antiviral effects compared to placebo at all doses of active drug examined and
was generally well tolerated.





“These
phase 2 clinical results confirm our previously announced interim findings which
showed that subcutaneous PRO 140 therapy was potent, long-acting and well
tolerated,” said Paul J. Maddon, M.D., Ph.D., Progenics Pharmaceuticals’
Founder, Chief Executive Officer and Chief Science Officer. “We plan to meet
with the U.S. Food and Drug Administration to discuss registrational studies for
subcutaneous PRO 140. Similar to intravenous PRO 140, the subcutaneous form has
demonstrated significant antiviral activity and favorable tolerability in
clinical trials to date, with the additional potential benefit of convenient
self-administration by patients. Given that all currently available HIV drugs
are given between one and three times daily, a weekly therapy could have many
advantages related to adherence.”




PRO 140
is a humanized monoclonal antibody that blocks viral infection of healthy cells
by binding to CCR5, a co-receptor that is the principal molecular portal used by
HIV to enter and infect immune system cells. Some strains of HIV use the CXCR4
co-receptor as a portal of entry either exclusively or in addition to CCR5. CCR5
viral-entry inhibitors, such as PRO 140, are active in blocking infection
primarily in HIV patients whose virus uses the CCR5 portal, but do not block the
entry of virus that uses the CXCR4 portal.








The data
presented yesterday indicate that PRO 140 has the potential to be administered
weekly, which may facilitate its use in conjunction with other antiretroviral
therapies. In this study, all active doses of subcutaneous PRO 140 demonstrated
potent and highly significant antiviral effects compared to placebo. A mean
maximum reduction in plasma levels of HIV RNA of 1.65 log10 (98%) was
observed following three weekly doses of 324 mg, the highest dose tested. All
dose levels were generally well tolerated.





“The
results of this clinical trial establish the first ever proof of concept for a
long-acting HIV therapy with the potential for self-administration,” said
Melanie A. Thompson M.D., Principal Investigator of the AIDS Research Consortium
of Atlanta and lead author of the CROI presentation. “Given its favorable
tolerability profile and potential for convenient weekly dosing by patients,
subcutaneous PRO 140 holds promise in providing a potent and novel treatment
option for individuals living with HIV.”





Subcutaneous
PRO 140: Summary of phase 2 clinical trial results





In the phase 2 clinical trial of
subcutaneous PRO 140, a total of 44 HIV-infected individuals who were treatment
naïve or had discontinued therapy for at least three months were randomized to
receive three weekly doses of 162 mg PRO 140, two bi-weekly (every-other-week)
doses of 324 mg PRO 140, three weekly doses of 324 mg PRO 140, or placebo.
Subjects were followed for a total of 58 days for safety and antiviral
effects.





In this
study, the following activity for PRO 140 was observed:





o
            For
      the 324 mg weekly dose group, a mean maximum reduction of 1.65 log10
      (p<0.0001) was observed, with a 1.51 log10
      mean reduction in viral load (p<0.0001) observed at day
    22.


o
            For
      the 324 mg dose tested on a bi-weekly basis, a mean maximum reduction of
      1.37 log10(p=0.0001) was observed, with a 1.20 log10mean reduction in viral load (p=0.0001) observed at day
      22.


o
            For
      the 162 mg weekly dose group, a mean maximum reduction of 0.99 log10
      (p=0.0093) was observed, with a 0.75 log10
      mean reduction in viral load (p=0.0072) observed at day
  22.





Figure
1*
depicts the mean change in viral load over time for the four dose
groups:  for each of the 324 mg dose groups, the mean viral load
decreased with each successive treatment, indicating sustained viral suppression
by PRO 140.













Subcutaneous
PRO 140 was generally well tolerated compared to placebo, with mild and
transient local reactions at the site of infusion occurring in a minority of
subjects. There were no drug-related serious adverse events and no study
discontinuations related to PRO 140.





The poster, Weekly and Biweekly Subcutaneous PRO
140 Demonstrates Potent, Sustained Antiviral
Activity, was presented at CROI on February 9, 2009 at 1:00 p.m.
ET.





*To view
the abstract and poster, as well as a graph depicting the mean change in viral
load over time for the four dose groups, please visit the following link
[site]:





http://www.progenics.com/eventdetail.cfm?eventid=65657









About
PRO 140




Discovered
by Progenics’ scientists, PRO 140 is a humanized monoclonal antibody that
binds to CCR5, a co-receptor characterized by Progenics and its collaborators in
1996 as the principal molecular portal used by HIV to enter and infect immune
system cells. Some strains of HIV use the CXCR4 co-receptor as a portal of entry
either exclusively or alternatively to CCR5. Unlike small-molecule CCR5
antagonists, PRO 140 inhibits HIV entry at concentrations that in vitro do not appear to
block CCR5’s natural activity of directing the migration of immune cells towards
sites of inflammation in the body. As a viral-entry inhibitor, PRO 140 is
designed to treat HIV by protecting healthy cells from infection. As a
monoclonal antibody, PRO 140 is not metabolized by the liver, and therefore
may have the potential for a better tolerability profile than many of the
existing small-molecule therapies for HIV infection. In February 2006,
PRO 140 was designated a Fast Track product by FDA for the treatment of HIV
infection.





Progenics
gratefully acknowledges the development funding it has received for PRO 140
from the National Institute of Allergy and Infectious Diseases, part of the
National Institutes of Health (Public Health Service award: 1 U19
AI066329).





About
the Company





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, virology—including human immunodeficiency virus (HIV) and
hepatitis C virus (HCV) infections—and oncology. Progenics, in collaboration
with Wyeth, is developing RELISTOR®
(methylnaltrexone bromide) for the treatment of opioid-induced side effects.
RELISTOR is currently approved in over 30 countries, which include approvals in
the U.S., Canada and Australia, as well as all European Union member countries.
In the U.S., RELISTOR (methylnaltrexone bromide) subcutaneous injection is
indicated for the treatment of opioid-induced constipation (OIC) in patients
with advanced illness who are receiving palliative care, when response to
laxative therapy has not been sufficient. Marketing applications are pending for
RELISTOR in other countries. In the area of virology, Progenics is developing
the HIV entry inhibitor PRO 140, a humanized monoclonal antibody targeting the
entry co-receptor CCR5, which is currently in phase 2 clinical testing. The
Company is also developing a novel HCV entry inhibitor, PRO 206. In the area of
oncology, the Company is conducting a phase 1 clinical trial of a human
monoclonal antibody-drug conjugate (ADC) for the treatment of prostate cancer—a
selectively targeted cytotoxic antibody directed against prostate-specific
membrane antigen (PSMA). PSMA is a protein found on the surface of prostate
cancer cells as well as in blood vessels supplying other solid tumors. Progenics
is also conducting a phase 1 clinical trial with a vaccine designed to treat
prostate cancer by stimulating an immune response to PSMA.




DISCLOSURE NOTICE: This
document contains statements that do not relate strictly to historical fact, any
of which may be forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. When we use the words “anticipates,”
“plans,” “expects” and similar expressions, we are identifying forward-looking
statements.













Forward-looking
statements involve known and unknown risks and uncertainties which may cause our
actual results, performance or achievements to be materially different from
those expressed or implied by forward-looking statements. While it is impossible
to identify or predict all such matters, this may result from, among other
things, the inherent uncertainty of the timing and success of, and expense
associated with, research, development, regulatory approval and
commercialization of our products and product candidates, including the risks
that clinical trials will not commence or proceed as planned; products appearing
promising in early trials will not demonstrate efficacy or safety in
larger-scale trials; clinical trial data on our products and product candidates
will be unfavorable; our products will not receive marketing approval from
regulators or, if approved, do not gain sufficient market acceptance to justify
development and commercialization costs; we, our collaborators or others might
identify side effects after the product is on the market; or efficacy or safety
concerns regarding marketed products, whether or not originating from subsequent
testing or other activities by us, governmental regulators, other entities or
organizations or otherwise, and whether or not scientifically justified, may
lead to product recalls, withdrawals of marketing approval, reformulation of the
product, additional pre-clinical testing or clinical trials, changes in labeling
of the product, the need for additional marketing applications, declining sales
or other adverse events.




We
are also subject to risks and uncertainties associated with the actions of our
corporate, academic and other collaborators and government regulatory agencies;
potential product liability; intellectual property, litigation, environmental
and other risks; the risk that licenses to intellectual property may be
terminated for our failure to satisfy performance milestones; the risk of
difficulties in, and regulatory compliance relating to, manufacturing products;
and the uncertainty of our future profitability.




Risks
and uncertainties also include general economic conditions, including interest
and currency exchange rate fluctuations and the availability of capital; changes
in generally accepted accounting principles; the impact of legislation and
regulatory compliance; the highly regulated nature of our business, including
government cost-containment initiatives and restrictions on third-party payments
for our products; trade buying patterns; the competitive climate of our
industry; and other factors set forth in our Annual Report on Form 10-K and
other reports filed with the U.S. Securities and Exchange Commission. In
particular, we cannot assure you that our lead product, RELISTOR TM , will be
commercially successful or be approved in the future in other formulations,
indications or jurisdictions, or that any of our other programs will result in a
commercial product.




We
do not have a policy of updating or revising forward-looking statements and
assume no obligation to update any statements as a result of new information or
future events or developments. Thus, it should not be assumed that our silence
over time means that actual events are bearing out as expressed or implied in
forward-looking statements.




###





Editors
Note:




For more
information about Progenics Pharmaceuticals, Inc., please visit www.progenics.com.