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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) May 22, 2000
Progenics Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware 000-23143 13-3379479
(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
777 Old Saw Mill River Road, Tarrytown, New York 10591
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (914) 789-2800
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(Former name or former address, if changed since last report.)
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Item 5. Other Events.
Progenics Pharmaceuticals, Inc. reported the information contained in the
following press releases:
PROGENICS ANNOUNCES PROMISING RESULTS WITH NOVEL TREATMENT FOR
DEBILITATING CANCER THERAPY SIDE EFFECT
NEW ORLEANS, L.A., May 22, 2000 -- Progenics Pharmaceuticals, Inc. (Nasdaq:
PGNX) presented promising new findings on a novel treatment strategy for oral
mucositis, a disease characterized by inflammation and ulceration of the lining
of the mouth associated with cancer chemotherapy or radiation therapy. The
results were described at the 36th annual meeting of the American Society of
Clinical Oncology (ASCO).
In an oral presentation, Robert J. Israel, M.D., Progenics' Vice President
of Medical Affairs, described new findings with topical dehydroascorbic acid
(DHA) treatment in an animal model of oral mucositis. Oral mucositis is a
painful and dose-limiting toxicity which occurs in over one-third of patients
receiving cancer chemotherapy and virtually all patients receiving radiation
therapy for head and neck tumors. Dr. Israel reported that administration of
topical DHA provided significant efficacy, reducing the overall duration of
clinically significant lesions by about 50% compared to control (p<0.001). The
effect of topical DHA was most notable during the early stages of mucositis
development and during the healing phase.
The effect of topical DHA on the development, severity, and resolution of
oral ulcerative mucositis induced by acute radiation was evaluated in the
hamster model developed by Progenics' collaborator Stephen T. Sonis, D.M.D.,
D.M.Sc., Division of Oral Medicine, Brigham and Women's Hospital in Boston, MA.
DHA is a chemical which is specifically transported into cells in the lining of
the mouth where it is rapidly converted to ascorbic acid. Ascorbic acid is a
potent antioxidant and is required for vascular and connective tissue integrity,
which play critical roles in the formation and healing of ulcers.
"Oral mucositis is a huge problem in cancer therapy. There are no effective
treatments available for this common side effect of cancer therapy which can
lead to the inability to eat and drink, limits additional cancer treatment, and
can lead to life-threatening infection," said Dr. Israel. "We are excited about
the significant activity observed with topical DHA in the best available animal
model of oral mucositis. Future studies will focus on optimizing the dose and
formulation of DHA as a prelude to human clinical trials."
Progenics Pharmaceuticals, Inc. is a biopharmaceutical company focusing on
the development and commercialization of products for the treatment and
prevention of cancer, viral, and other life-threatening diseases. The Company's
most advanced 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 entering Phase II trials. GMK
and MGV are being developed in collaboration with Bristol-Myers Squibb Company.
The Company, with Cytogen Corporation, has formed a joint venture focusing on
the development of cancer immunotherapies based on PSMA (Prostate Specific
Membrane Antigen) technology. The Company's lead HIV product, PRO 542, has
completed two Phase I/II clinical trials, and two additional HIV products, PRO
367 and PRO 140, are preparing to commence Phase I/II trials. Progenics also has
collaborations with F. Hoffmann-La Roche Ltd in the area of HIV fusion
co-receptors, and with American Home Products and Pharmacopeia, Inc. focusing on
small-molecules targeting the CD4 receptor. The Company is developing a novel
small-molecule antioxidant, DHA, to treat stroke and other disorders.
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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
Form 10-K Annual Report for the year ended December 31, 1999, 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 DHA program will result in a commercial product.
PROGENICS ANNOUNCES NEWS ON CANCER VACCINE TRIAL
TARRYTOWN, N.Y., May 26, 2000 -- Progenics Pharmaceuticals, Inc. (Nasdaq:
PGNX) announced today that the Eastern Cooperative Oncology Group (ECOG) will
conclude their participation in the Company's Phase III clinical trial for the
GMK melanoma vaccine. The Company announced that it plans to continue the trial
as an extension study until the scheduled completion of the original trial.
The Company is taking this action after ECOG performed an unplanned early
analysis on a subset of the 880 patients enrolled in the trial. Although the
trial is fully enrolled, the analysis was conducted at a time when only about
half of the patients had received the two years of GMK therapy provided in the
study protocol and most of the interferon patients had completed their full
course of therapy. ECOG informed Progenics that the interim analysis indicated
that the relapse-free and overall survival rates for patients receiving the
vaccine were lower than those for patients receiving high-dose alpha-interferon,
an approved agent with a well-documented early onset of clinical effect. As
expected, GMK was better tolerated than alpha-interferon with about five times
less frequent and much less severe side effects.
The Company plans to continue the trial under the belief that the follow-
up period has been too brief for the full benefit of GMK therapy to be realized.
"It was known when the Phase III trial started that GMK therapy requires the
body to develop an immune response to the vaccine," said Alan N. Houghton, M.D.,
Chairman of Progenics' Cancer Scientific Advisory Board, Chairman, Immunology
Program, Memorial Sloan-Kettering Cancer Center and Professor, Cornell
University Medical Center in New York City. "The onset of clinical effect for a
vaccine appears later than that of other cancer therapies which are given in
high doses over a much shorter period of time. From what we know, the
relapse-free and overall survival rates for the GMK vaccine in the Phase III
trial are tracking generally as expected at this time based on our previous
clinical experience."
"ECOG has been indispensable in its ability to enroll 880 melanoma patients
over a relatively short period," said Progenics' Chairman and CEO Paul J.
Maddon, M.D., Ph.D.. "With full accrual, ECOG has substantially completed its
contribution to the trial. We believe that in the longer term, the benefits of
this innovative therapy to melanoma patients can be demonstrated."
Progenics Pharmaceuticals, Inc. is a biopharmaceutical company focusing on
the development and commercialization of products for the treatment and
prevention of cancer and viral diseases. In addition to GMK the Company's second
cancer vaccine, MGV, with broad application to a variety of cancers, is entering
Phase II trials. The Company has a collaboration with Bristol-Myers Squibb
Company for the development of GMK and MGV. The Company, with Cytogen
Corporation, has formed a joint venture focusing on the development of cancer
immunotherapies based on PSMA (Prostate Specific Membrane Antigen) technology.
The Company's lead HIV product PRO 542, has completed two Phase I/II clinical
trials. Progenics has two additional HIV products, PRO 367 and PRO 140, which
are preparing to commence Phase I/II trials. Progenics also has collaborations
with F.
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Hoffmann-La Roche Ltd in the area of HIV fusion co- receptors, and with American
Home Products and Pharmacopeia, Inc. focusing on small-molecules targeting the
CD4 receptor.
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
Form 10-K Annual Report for the year ended December 31, 1999, 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 GMK vaccine program will achieve any of the
specified milestones or result in the commercialization of a product.
PROGENICS IDENTIFIES THE HIV DOCKING SITE ON CCR5 RECEPTOR
TARRYTOWN, N.Y., May 30, 2000 -- Progenics Pharmaceuticals, Inc. (Nasdaq:
PGNX) reported today the discovery of the binding site for HIV on CCR5, a
receptor protein found on cells that plays a critical role in HIV entry and
infection. The new structural data provide researchers with a better
understanding of how HIV infects cells and will contribute to the development of
novel therapies for HIV. Conducted by a collaborative team of researchers from
Progenics, Albert Einstein College of Medicine (Bronx, NY) and Rockefeller
University (New York, NY), the study was reported in the current issue of the
Proceedings of the National Academy of Sciences USA (Vol. 97, No. 11).
To pinpoint the HIV binding site, Progenics' scientists and their
collaborators tested the binding of synthetic CCR5 molecules to the HIV envelope
glycoprotein gp120, which resides on the surface of the virus and mediates HIV
entry. They observed that HIV bound a particular region or sequence of CCR5 and
that it only occurred when the site contained sulfate groups at specific
locations. Sulfate groups are naturally added to certain receptors like CCR5 in
vivo. These findings were confirmed in laboratory tests which showed that
sulfated CCR5 peptides blocked HIV infection of target cells. Progenics has used
this discovery as the basis of a new scientific discovery program focusing on
the development of antiviral therapies targeting the CCR5 binding site on HIV.
"These discoveries provide the first detailed description of the
interactions between HIV and CCR5," said Ronald J. Prentki, President of
Progenics. "We believe that these findings represent an important contribution
to our understanding of how the virus infects cells and will ultimately advance
the development of CCR5-based therapies for HIV infection."
Progenics Pharmaceuticals, Inc. is a biopharmaceutical company focusing on
the development and commercialization of products for the treatment and
prevention of cancer, viral, and other life-threatening diseases. The Company's
most advanced 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 entering Phase II trials. GMK
and MGV are being developed in collaboration with Bristol-Myers Squibb Company.
The Company, with Cytogen Corporation, has formed a joint venture focusing on
the development of cancer immunotherapies based on PSMA (Prostate Specific
Membrane Antigen) technology. The Company's lead HIV product, PRO 542, has
completed two Phase I/II clinical trials, and two follow-on HIV products, PRO
367 and PRO 140, are preparing to commence Phase I/II trials. Progenics also has
collaborations with F. Hoffmann-La Roche Ltd in the area of HIV fusion
co-receptors, and with American Home Products and Pharmacopeia, Inc. focusing on
small-molecules targeting the CD4 receptor. The Company is developing a novel
small-molecule antioxidant, DHA, to treat stroke and other neurological
disorders.
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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
Form 10-K Annual Reports for the year ended December 31, 1999, 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 HIV programs will achieve any of the specified
milestones or result in the commercialization of a product.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
PROGENICS PHARMACEUTICALS, INC.
By /s/ ROBERT A. MCKINNEY
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Robert A. McKinney
Vice President, Finance and Operations
and Treasurer
(Principal financial and accounting
officer)
Date May 31, 2000
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