Data from Pivotal Phase 2b Study of Progenics’ AZEDRA® (iobenguane I 131) to be Presented at the North American Neuroendoc...
October 04 2017 - 8:30AM
Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company
developing innovative medicines and imaging analytical tools for
targeting and treating cancer, announced today that results from
the Company’s Phase 2b study of AZEDRA®, a radiotherapeutic
candidate to treat rare neuroendocrine tumors, will be presented in
an oral session at the North American Neuroendocrine Tumor Society
(NANETS) 2017 Annual Symposium. The symposium is being held at the
Philadelphia Marriott Downtown hotel in Philadelphia, Pennsylvania
from October 19 through 21, 2017.
Presentation details are as follows:
Date & Time: Friday,
October 20, 2017, 9:20AM - 10:35AM Eastern Daylight Time
(EDT)Session Title: Clinical Science Symposium
#1Session Type: Oral Abstract
PresentationTitle: AZEDRA® (iobenguane I 131) in
Patients with Malignant and/or Recurrent Pheochromocytoma/
Paraganglioma (PPGL): Final Results of a Multi-Center,
Open-Label, Pivotal Phase 2b Study
About AZEDRA®
AZEDRA® (iobenguane I 131), a radiotherapeutic
product candidate in development as a treatment for malignant
and/or recurrent pheochromocytoma and paraganglioma, rare tumors
found in the adrenal glands and outside of the adrenal glands,
respectively. AZEDRA has been granted Breakthrough Therapy and
Orphan Drug designations, as well as Fast Track status in the U.S.
Under a SPA agreement with the U.S. Food and Drug Administration
(FDA), a Phase 2 pivotal study has been completed in patients with
malignant and/or recurrent and/or unresectable pheochromocytoma and
paraganglioma. There are currently no FDA-approved therapies
for the treatment of these ultra-orphan diseases.
About Pheochromocytoma and
Paraganglioma
Pheochromocytoma and paraganglioma are rare
neuroendocrine tumors that arise from cells of the autonomic
nervous system. When pheochromocytomas are located outside the
adrenal glands, they are called paragangliomas. Standard treatment
options for these tumors include surgery, palliative therapy and
symptom management. Pheochromocytoma and paraganglioma tumors
frequently secrete high levels of hormones that can lead to life
threatening hypertension, heart failure, and stroke in these
patients. Malignant and recurrent pheochromocytoma and
paraganglioma may result in unresectable disease with a poor
prognosis, representing a significant management challenge with
very limited treatment options and no approved anti-tumor
therapies.
About Progenics
Progenics develops innovative medicines and
other technologies to target and treat cancer. Progenics' pipeline
includes: 1) therapeutic agents designed to precisely target cancer
(AZEDRA® and 1095), 2) PSMA-targeted imaging agents for prostate
cancer (1404 and PyL™), and 3) imaging analysis tools. Progenics'
first commercial product, RELISTOR® (methylnaltrexone bromide) for
opioid-induced constipation, is partnered with Valeant
Pharmaceuticals International, Inc.
This press release may contain projections and
other "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 generally
will be 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; our ability to successfully develop and
commercialize the products of EXINI Diagnostics AB; the
unpredictability of the duration and results of regulatory review
of New Drug Applications (NDA) and Investigational NDAs, including
our NDA for AZEDRA; 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. 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. Please follow us on
LinkedIn®. 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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