Leading Medical Oncologist and Hematologist
Dr. Lee Schwartzberg Joins Mytesi Scientific Advisory Board for
Cancer Therapy-Related Diarrhea (CTD)—An Area of Significant
Concern for Diarrhea Management in the Era of Novel Targeted Agents
Such as Recently Approved CDK 4/6 and Tyrosine Kinase
Inhibitors
Jaguar Health, Inc. (NASDAQ: JAGX) (Jaguar), a natural-products
pharmaceuticals company focused on developing and commercializing
novel, sustainably derived gastrointestinal products for both human
prescription use and animals on a global basis, announced today
that its wholly-owned subsidiary, Napo Pharmaceuticals, Inc.
(Napo), has established a scientific advisory board for each
potential follow-on indication currently planned for Mytesi®
(crofelemer), Napo’s FDA-approved, first-in-class anti-secretory
human prescription drug. Additionally, Jaguar announced today that
Dr. Lee Schwartzberg, MD, FACP, a nationally-recognized medical
oncologist and hematologist, has joined Napo’s scientific advisory
board for cancer therapy-related diarrhea (CTD).
Mytesi® is approved by the FDA for the symptomatic relief of
noninfectious diarrhea in adults with HIV/AIDS on antiretroviral
therapy. Napo is pursuing a follow-on indication for Mytesi® in
CTD, an important supportive care indication for patients
undergoing primary or adjuvant therapy for cancer treatment.
Mytesi® is also in development for rare disease indications for
infants and children with congenital diarrheal disorders and short
bowel syndrome (SBS); for irritable bowel syndrome (IBS) (Mytesi®
has demonstrated a reduction in pain in IBS-D patients in Phase 2
studies); for supportive care for inflammatory bowel disease (IBD);
and as a second-generation anti-secretory agent for use in cholera
patients. Mytesi® has received orphan-drug designation for SBS.
Napo has identified more than 30 physicians, pharmacists and
patient advocates around the world who are recognized specialists
and key opinion leaders in the planned Mytesi® follow-on
indications listed above, and is conducting outreach efforts to
discuss the possibility of membership in Napo’s new scientific
advisory boards with these individuals.
Napo has also established a scientific advisory board for HIV.
This board will focus primarily on physician education and
community awareness regarding the importance and availability of
solutions for neglected comorbidities, such as the first-in-class
anti-secretory mechanism of action of Mytesi® for its currently
approved indication.
Dr. Lee Schwartzberg, MD, FACP, Joins Napo Scientific
Advisory Board for CTD
Dr. Lee Schwartzberg, a nationally-recognized medical oncologist
and hematologist, has joined Napo’s scientific advisory board for
CTD. Dr. Schwartzberg is the Executive Director of West Cancer
Center in Memphis, Tennessee, and is the Medical Director and a
senior partner of West Clinic. He is also a Professor of Medicine
and Chief of the Division of Hematology/Oncology at the University
of Tennessee Health Science Center, and serves as President/CMO for
Vector Oncology, an oncology-specific site management
organization/contract research organization.
“Diarrhea remains an area of concern for patients undergoing
cancer treatment. In this era of novel targeted agents, epidermal
growth factor receptor tyrosine kinase inhibitors (TKIs), in
particular, may block natural chloride secretion regulation
pathways in the normal gastrointestinal mucosa, thereby leading to
secretory diarrhea,” Dr. Schwartzberg commented. “Diarrhea has been
reported as the most common side effect of the recently approved
CDK 4/6 inhibitor abemaciclib and the pan-HER TKI neratinib, with
occurrence ranging from 86% to >95% in published studies.
Diarrhea in this patient population has the potential to cause
dehydration, potential infections, and non-adherence to treatment.
A novel anti-diarrheal like Mytesi® may hold promise for treating
secretory diarrhea—and therefore also support long-term cancer
treatment adherence—in this population.”
Dr. Schwartzberg was the founding editor-in-chief of the journal
Community Oncology and currently serves as the editor-in-chief of
the Practice Update Oncology website. He serves on the editorial
board of both the Journal of Supportive Oncology and The ASCO Post,
in addition to serving as a reviewer for many prominent medical
journals, including the New England Journal of Medicine and the
Journal of Clinical Oncology. Dr. Schwartzberg is also a member of
the board of directors for the National Comprehensive Cancer
Network. His major research interests are new therapeutic
approaches to breast cancer, targeted therapy and supportive care.
He has published more than 200 research papers during his oncology
career. Dr. Schwartzberg is board certified in internal medicine,
hematology, and medical oncology, and maintains a private practice
in medical oncology focusing on breast cancer.
“We are confident that our scientific advisory boards will
provide expert, actionable input regarding all aspects of
development, including trial design, for Mytesi® for our follow-on
indications—each of which addresses a significant, global, unmet
medical need—and we are extremely pleased and honored that an
oncologist and hematologist of Dr. Schwartzberg’s stature has
joined our scientific advisory board for CTD,” Dr. Pravin
Chaturvedi, chair of Napo’s scientific advisory boards, stated.
About Mytesi®
Mytesi® (crofelemer) is an antidiarrheal indicated for the
symptomatic relief of noninfectious diarrhea in adult patients with
HIV/AIDS on antiretroviral therapy (ART). Mytesi® is not indicated
for the treatment of infectious diarrhea. Rule out infectious
etiologies of diarrhea before starting Mytesi®. If infectious
etiologies are not considered, there is a risk that patients with
infectious etiologies will not receive the appropriate therapy and
their disease may worsen. In clinical studies, the most common
adverse reactions occurring at a rate greater than placebo were
upper respiratory tract infection (5.7%), bronchitis (3.9%), cough
(3.5%), flatulence (3.1%), and increased bilirubin (3.1%).
More information and complete Prescribing Information are
available at Mytesi.com. Crofelemer, the active ingredient in
Mytesi®, is a botanical (plant-based) drug extracted and purified
from the red bark sap of the medicinal Croton lechleri tree in the
Amazon rainforest. Napo has established a sustainable harvesting
program for crofelemer to ensure a high degree of quality and
ecological integrity.
About Jaguar Health, Inc.
Jaguar Health, Inc. is a natural-products pharmaceuticals
company focused on developing and commercializing novel,
sustainably derived gastrointestinal products for both human
prescription use and animals on a global basis. Our wholly-owned
subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and
commercializing proprietary human gastrointestinal pharmaceuticals
for the global marketplace from plants used traditionally in
rainforest areas. Our Mytesi® (crofelemer) product is approved by
the U.S. FDA for the symptomatic relief of noninfectious diarrhea
in adults with HIV/AIDS on antiretroviral therapy. Mytesi® is in
development for multiple possible follow-on indications, including
cancer therapy-related diarrhea; orphan-drug indications for
infants and children with congenital diarrheal disorders and short
bowel syndrome; supportive care for inflammatory bowel disease
(IBD); irritable bowel syndrome (IBS); and as a second-generation
anti-secretory agent for use in cholera patients. Canalevia™ is our
lead animal prescription drug candidate, intended for treatment of
various forms of diarrhea in dogs. Equilevia™ is Jaguar’s
non-prescription product for total gut health in equine athletes.
Canalevia™ and Equilevia™ contain ingredients isolated and purified
from the Croton lechleri tree, which is sustainably harvested.
Neonorm™ Calf and Neonorm™ Foal are Jaguar’s lead non-prescription
animal products. Mytesi®, Canalevia™, Equilevia™ and Neonorm™ are
distinct products that act at the same last step in a physiological
pathway generally present in mammals.
For more information about Jaguar, please visit jaguar.health.
For more information about Napo, visit napopharma.com.
Forward-Looking Statements
Certain statements in this press release constitute
“forward-looking statements.” These include statements regarding
planned, potential follow-on indications for Mytesi®, the potential
effectiveness of Mytesi® for treating CTD, and Jaguar’s and Napo’s
belief that its scientific advisory boards will provide expert,
actionable input regarding all aspects of development, including
trial design, for potential Mytesi® follow-on indications. In some
cases, you can identify forward-looking statements by terms such as
“may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,”
“could,” “intend,” “target,” “project,” “contemplate,” “believe,”
“estimate,” “predict,” “potential” or “continue” or the negative of
these terms or other similar expressions. The forward-looking
statements in this release are only predictions. Jaguar has based
these forward-looking statements largely on its current
expectations and projections about future events. These
forward-looking statements speak only as of the date of this
release and are subject to a number of risks, uncertainties and
assumptions, some of which cannot be predicted or quantified and
some of which are beyond Jaguar’s control. Except as required by
applicable law, Jaguar does not plan to publicly update or revise
any forward-looking statements contained herein, whether as a
result of any new information, future events, changed circumstances
or otherwise.
Jaguar-JAGX
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KCSA Strategic CommunicationsGarth Russell,
212-896-1250grussell@kcsa.com
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