-Meets Co-Primary Endpoint of
Specificity; 1404 Successfully Identifies Patients Without
Clinically Significant Prostate Cancer--Co-Primary
Endpoint of Sensitivity to Identify Patients with Clinically
Significant Disease Not Met-
Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), an oncology company
developing innovative medicines and imaging analysis technology for
targeting and treating cancer, today announced top line data from
its Phase 3 study of 1404, the Company’s prostate specific membrane
antigen (PSMA)-targeted small molecule SPECT/CT imaging agent that
is designed to visualize prostate cancer.
The Phase 3 trial evaluated the specificity of
1404 imaging to identify patients without clinically significant
prostate cancer and sensitivity to identify patients with
clinically significant disease. The study dosed 471 patients in the
U.S. and Canada with low-grade prostate cancer, whose
biopsy indicated a histopathologic Gleason grade of ≤ 3+4 severity
and/or were candidates for active surveillance. Median PSA levels
for patients dosed in trial was 5.58 ng/mL (range 0.69 – 16.03). In
the study, 1404 detected clinically meaningful prostate cancer with
specificity ranging among the three readers from 71-75% (95%
confidence interval CI of 64% to 80%). The co-primary endpoint of
sensitivity was not met and ranged amongst the three readers from
47-51% (95% CI of 41% to 56%). The trial protocol required the
lower limit of the two-sided 95% CI for both specificity and
sensitivity to exceed 60%.
The most frequent treatment related events
included headache (2.3%), dizziness (1.1%) and fatigue (0.8%).
“These top line Phase 3 results of 1404 are
inconsistent with the prior Phase 2 data, which showed
significantly higher sensitivity rates,” stated Mark Baker, CEO of
Progenics. “We are currently conducting a thorough analysis of the
full data set to understand the factors that may have contributed
to this outcome and determine the appropriate development path for
this novel agent in patients with low-grade prostate cancer. We
plan to complete this review in the next quarter.”
Mr. Baker added, “We believe that PSMA-targeted
imaging holds tremendous promise to improve the detection, staging
and monitoring of prostate cancer. These results do not impact our
view of the PyL PET imaging agent in patients with recurrent or
metastatic prostate cancer as we head into our Phase 2/3 data
readout next quarter, and we remain on track to initiate our second
Phase 3 study by year-end. Our oncology therapeutic programs
continue to move forward, including the ongoing commercial launch
of AZEDRA® for the treatment of pheochromocytoma or paraganglioma.
In addition, we anticipate finalizing our clinical development plan
with the U.S. FDA for 1095 in metastatic castration-resistant
prostate cancer (mCRPC) in the fourth quarter and expect our
partner Bayer to initiate a Phase 1 study of PSMA-TTC in patients
with mCRPC by year end 2018.”
About the Phase 3 1404
Trial
The Phase 3 trial was a multi-center,
multi-reader, open-label trial, comparing 1404 SPECT/CT imaging in
men who had a diagnostic trans-rectal ultrasound (TRUS) guided
biopsy with a histopathologic finding of Gleason score ≤3+4 who
were candidates for active surveillance and were undergoing routine
biopsy or voluntary radical prostatectomy (RP) with or without a
pelvic lymph node dissection. This study was designed to evaluate
the sensitivity and specificity of 1404 SPECT/CT image assessments
to correctly identify subjects with previously unknown clinically
significant prostate cancer in two cohorts: low grade prostate
cancer who had elected to undergo RP; and very low risk (VLR)
prostate cancer per 2016 National Comprehensive Cancer Network
Guidelines who were scheduled to undergo routine prostate biopsy.
Subjects received a single dose of 1404 followed by whole body
planar and SPECT/CT (pelvic) imaging. In accordance with standard
of care procedures, subjects underwent either voluntary RP or
prostate biopsy within 42 days after study drug dosing. 1404 image
data was collected by a central imaging core laboratory and
evaluated for visible uptake within the prostate gland and then
compared against central histopathology as the truth standard.
About 1404, an Imaging Compound
Targeting Prostate Specific Membrane Antigen
Progenics' molecular imaging radiopharmaceutical
product candidate 1404 targets the extracellular domain of prostate
specific membrane antigen (PSMA), a protein amplified on the
surface of > 95% of prostate cancer cells and a validated target
for the detection of primary and metastatic prostate cancer. 1404
is labeled with Technetium-99m, a gamma-emitting isotope that is
widely available, is easy to prepare, and is attractive for nuclear
medicine imaging applications. The image created provides the
opportunity to visualize cancer, potentially allowing for improved
detection and staging, more precise biopsies, and a targeted
treatment plan including active surveillance as a disease
management tool.
About Prostate Cancer
Prostate cancer is the second most common form
of cancer affecting men in the United States: an estimated one
in seven men will be diagnosed with prostate cancer in his
lifetime. The American Cancer Society estimates that each
year approximately 161,360 new cases of prostate cancer will be
diagnosed and about 26,730 men will die of the disease.
Approximately 2.9 million men in the U.S. currently count
themselves among prostate cancer survivors.
About Progenics
Progenics develops innovative medicines and
other technologies to target and treat cancer, including:
therapeutic agents designed to treat cancer (AZEDRA®, 1095, and
PSMA TTC); prostate-specific membrane antigen (“PSMA”) targeted
imaging agents for prostate cancer (1404 and PyL™); and imaging
analysis technology. Progenics has two commercial products,
RELISTOR® (methylnaltrexone bromide) subcutaneous injection for the
treatment of opioid-induced constipation, which is partnered with
Salix Pharmaceuticals, Inc. (a wholly-owned subsidiary of Bausch
Health Companies Inc. (formerly known as Valeant Pharmaceuticals
International, Inc.)); and AZEDRA, for the treatment of patients
with unresectable, locally advanced or metastatic pheochromocytoma
or paraganglioma (rare neuroendocrine tumors of neural crest
origin) who require systemic anticancer therapy.
This press release contains "forward-looking
statements" regarding future events. Statements contained in this
communication that refer to Progenics' estimated or anticipated
future results or other non-historical facts are forward-looking
statements that reflect Progenics' current perspective of existing
trends and information as of the date of this communication.
Forward looking statements are generally accompanied by words such
as "anticipate," "believe," "plan," "could," "should," "estimate,"
"expect," "forecast," "outlook," "guidance," "intend," "may,"
"might," "will," "possible," "potential," "predict," "project," or
other similar words, phrases or expressions. 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
unpredictability of results of clinical trials and other
development activities and collaborations, such as the Phase 3
clinical program for 1404; market acceptance for approved products;
the effectiveness of the efforts of our partners to market and sell
products on which we collaborate and the royalty revenue generated
thereby; generic and other competition; the possible impairment of,
inability to obtain and costs of obtaining intellectual property
rights; possible product safety or efficacy concerns, general
business, financial, regulatory 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, including those risk factors included in its
Annual Report on Form 10-K for the fiscal year ended December 31,
2017, as updated in its subsequent Quarterly Reports on Form 10-Q.
Progenics is providing the information in this press release as of
its date and, except as expressly required by law, Progenics
disclaims any intent or obligation to update or revise any
forward-looking statements, 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. For more
information, please visit www.progenics.com. Information on or
accessed through our website or social media sites is not included
in the company's SEC filings.
(PGNX-F)
Contact: |
Melissa DownsInvestor Relations(646)
975-2533mdowns@progenics.com |
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