Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company
developing innovative medicines and other products for targeting
and treating cancer, announced that biochemical tumor marker data
from the Company’s pivotal Phase 2 trial of its targeted,
high-specific-activity radiotherapeutic candidate, AZEDRA®
(iobenguane I 131), in patients with malignant, recurrent, and/or
unresectable pheochromocytoma and paraganglioma (pheo/para) were
presented at the Endocrine Society (ENDO) Annual Meeting in
Chicago, Illinois.
“In this pivotal study of AZEDRA in pheo and
para patients, the overall tumor biomarker response correlated
significantly with responder status with both the primary and
secondary endpoints,” said Dr. Camilo Jimenez, Associate Professor,
Department of Endocrine Neoplasia and Hormonal Disorders at the
University of Texas M. D. Anderson Cancer Center. “AZEDRA has
already been shown to have a significant positive impact on the
cardiovascular symptoms associated with pheochromocytoma and
paraganglioma. It has also demonstrated objective antitumor effects
as measured by Response Evaluation Criteria In Solid Tumors
(RECIST) criteria. The biochemical tumor marker data presented
today provides further evidence of AZEDRA’s potential to offer a
meaningful treatment option for patients with these
life-threatening tumors.”
Dr. Jimenez reviewed the data in an oral
presentation titled, “AZEDRA® (iobenguane I 131) in Patients with
Metastatic and/or Recurrent and/or Unresectable Pheochromocytoma or
Paraganglioma: Biochemical Tumor Marker Results of a Multicenter,
Open-Label Pivotal Phase 2 Study.”
Tumor biomarkers were analyzed in patients who
had individual tumor biomarkers above 1.5x the upper limit of
normal (ULN) at baseline. The overall tumor biomarker response
correlated with responder status for those who met the study’s
primary endpoint (r = 0.31, p = 0.011) and objective tumor response
(r=0.35, p=0.006). The biomarkers evaluated were Chromogranin A
(CgA, serum), Normetanephrine (NM, serum and urine) and
Norepinephrine (NE, serum and urine). At 12 months following the
first therapeutic dose of AZEDRA, urine and serum NE showed best
response (CR/PR) rates of 42.1% and 31.0%, respectively, and urine
and serum NM responder rates of 36.0% and 44.0%,
respectively. In addition, serum CgA showed best response
rate of 67.9% at 12 months.
“The compelling results from this pivotal trial
formed the basis of our New Drug Application for AZEDRA, which was
accepted for review by the FDA at the end of 2017,” said Mark
Baker, Chief Executive Officer of Progenics. “We are eagerly
awaiting the FDA’s action date at the end of April for our
innovative radiopharmaceutical treatment. AZEDRA has the potential
to be the first FDA-approved therapy to address the high unmet need
of patients with malignant pheo and para.”
The pivotal phase 2 open-label, multi-center
trial was conducted under a Special Protocol Assessment (SPA) with
the U.S. Food and Drug Administration (FDA). The trial met the
primary endpoint evaluating the proportion of pheochromocytoma and
paraganglioma patients who achieved a 50% or greater reduction of
all antihypertensive medication for at least six months, and showed
favorable results from a key secondary endpoint evaluating the
proportion of patients with overall tumor response as measured by
RECIST. AZEDRA was also shown to be safe and generally well
tolerated.
About AZEDRA®
AZEDRA (iobenguane I 131) is a
high-specific-activity radiotherapeutic product candidate in
development as a treatment for malignant, recurrent, or
unresectable pheochromocytoma and paraganglioma, which are rare
neuroendocrine tumors of neural crest origin. AZEDRA is a
substrate for norepinephrine reuptake transporter which is highly
expressed on the cell surface of neuroendocrine tumors. AZEDRA
has been granted Orphan Drug designation, Fast Track status, and
Breakthrough Therapy designation in the U.S. Under a SPA
agreement with the FDA, a Phase 2 pivotal study has been
completed in patients with malignant, recurrent, or unresectable
pheochromocytoma and paraganglioma. The FDA granted Priority
Review of Progenics’ New Drug Application and has set an action
date of April 30, 2018 under the Prescription Drug User Fee Act.
There are currently no FDA-approved therapies for the
treatment of these ultra-rare diseases.
About Pheochromocytoma and
Paraganglioma
Pheochromocytoma and paraganglioma are rare
neuroendocrine tumors that arise from cells of the autonomic
nervous system. Pheochromocytoma forms in the adrenal medulla,
whereas paragangliomas form outside the adrenal gland. 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®, 1095, and PSMA TTC), 2) PSMA-targeted imaging agents for
prostate cancer (1404 and PyL™), and 3) imaging analysis
technology. 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 and related inspections of Progenics’ and its
contract manufacturing organizations’ facilities and other sites
and other requirements that will need to be met before any approval
is obtained; 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 annual period ended December 31,
2017. 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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