Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage
company developing transformative therapies for the treatment of
cancer and rare diseases, today announced that it will present
a Trials in Progress poster related to its ADVANCED-1 Phase 1 trial
at the Annual Meeting of the Society of Urologic Oncology being
held in San Diego, California from November 30, 2022 through
December 2, 2022. The ADVANCED-1 study is evaluating TARA-002, an
investigational cell-based immunopotentiator, for the treatment of
non-muscle invasive bladder cancer (NMIBC).
“This large addressable patient population is
underserved by current treatment options which drives significant
unmet need in NMIBC, and leaves room for creative therapeutic
approaches such as TARA-002,” said Jathin Bandari, M.D., Chief
Medical Officer of Protara Therapeutics. “Based on TARA-002’s
immune-potentiating mechanism of action and supportive clinical
data from its predecessor compound OK-432 in multiple solid tumors,
we are excited to continue our ongoing ADVANCED-1 trial exploring
TARA-002 in NMIBC and look forward to expanding our clinical
development program.”
Details of the poster presentation are as
follows:
Title: Phase 1a/b Safety
Study of Intravesical Instillation of TARA-002 in Adults with
High-grade Non-muscle Invasive Bladder Cancer
(ADVANCED-1)Poster Number: 191Poster
Category: Bladder 4 (Bladder Cancer > Non-Muscle
Invasive Bladder Cancer) Session Title:
E-Poster Displays Session Date and
Time: Friday, December 2 at 9:00 a.m. - 10:00
a.m.Location: Sapphire ABEFIJMN, Hilton San Diego
Bayfront, San Diego, California
ADVANCED-1 is a Phase 1 dose-finding, open-label
trial (NCT05085977 and NCT05085990) evaluating TARA-002 in
treatment-naïve and treatment-experienced NMIBC patients with
high-grade carcinoma in situ (CIS) and high-grade papillary tumors
(Ta). In the initial dose escalation phase of the trial, patients
will receive six weekly intravesical doses of TARA-002. The primary
objective of the trial is to evaluate the safety, tolerability and
preliminary signs of anti-tumor activity of TARA-002, with the goal
of establishing a recommended dose for a planned Phase 2 clinical
trial.About TARA-002
TARA-002 is an investigational cell therapy in
development for the treatment of NMIBC and LMs for which it has
been granted Rare Pediatric Disease Designation by
the U.S. Food and Drug Administration. TARA-002 was
developed from the same master cell bank of genetically distinct
group A Streptococcus pyogenes as OK-432, a broad immunopotentiator
marketed as Picibanil® in Japan and Taiwan by
Chugai Pharmaceutical Co., Ltd.
When TARA-002 is administered, it is
hypothesized that innate and adaptive immune cells within the cyst
or tumor are activated and produce a strong immune cascade.
Neutrophils, monocytes and lymphocytes infiltrate the abnormal
cells and various cytokines, including interleukins (IL)-2, IL-6,
IL-8, IL-10, IL-12, interferon (IFN)-gamma, tumor necrosis factor
(TNF)-alpha, granulocyte colony-stimulating factor, and
granulocyte-macrophage colony-stimulating factor, are secreted by
immune cells to induce a strong local inflammatory reaction and
destroy the abnormal cells.
About Non-Muscle Invasive Bladder CancerBladder
cancer is the 6th most common cancer in the United States,
with NMIBC representing approximately 80% of bladder cancer
diagnoses. Approximately 65,000 patients are diagnosed with NMIBC
in the United States each year. NMIBC is cancer found in
the tissue that lines the inner surface of the bladder that has not
spread into the bladder muscle.
About Protara
Therapeutics, Inc.
Protara is committed to identifying and
advancing transformative therapies for people with cancer and rare
diseases with limited treatment options. Protara’s portfolio
includes its lead program, TARA-002, an investigational cell-based
therapy being developed for the treatment of non-muscle invasive
bladder cancer and lymphatic malformations, and IV Choline
Chloride, an investigational phospholipid substrate replacement
therapy for the treatment of intestinal failure-associated liver
disease. For more information, visit www.protaratx.com.
Forward-Looking
StatementsStatements contained in this press release
regarding matters that are not historical facts are "forward
looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995. Protara may, in some cases, use
terms such as “predicts,” “believes,” “potential,” “proposed,”
“continue,” “designed,” “estimates,” “anticipates,” “expects,”
“plans,” “intends,” “may,” “could,” “might,” “will,” “should” or
other words or expressions referencing future events, conditions or
circumstances that convey uncertainty of future events or outcomes
to identify these forward-looking statements. Such forward-looking
statements include but are not limited to, statements regarding
Protara’s intentions, beliefs, projections, outlook, analyses or
current expectations concerning, among other things: Protara’s
business strategy, including its development plans for its product
candidates and plans regarding the timing or outcome of existing or
future clinical trials; statements related to expectations
regarding interactions with the FDA, including potential alignment
with the FDA on, and finalization of, clinical trial design for
TARA-002 in pediatric LM patients; Protara’s financial footing;
statements regarding the anticipated safety or efficacy of
Protara’s product candidates; and Protara’s outlook for the
remainder of the year. Because such statements are subject to risks
and uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Factors
that contribute to the uncertain nature of the forward-looking
statements include: risks that Protara’s financial guidance may not
be as expected, as well as risks and uncertainties associated
with:
Protara’s development programs, including the
initiation and completion of non-clinical studies and clinical
trials and the timing of required filings with the FDA and other
regulatory agencies; the impact of the COVID-19 pandemic on
Protara’s business and the global economy as well as the impact on
Protara’s contract research organizations, study sites or other
clinical partners; general market conditions; changes in the
competitive landscape; changes in Protara’s strategic and
commercial plans; Protara’s ability to obtain sufficient financing
to fund its strategic plans and commercialization efforts; having
to use cash in ways or on timing other than expected; the impact of
market volatility on cash reserves; the loss of key members of
management; the impact of general U.S. and foreign, economic,
industry, market, regulatory or political conditions; and the risks
and uncertainties associated with Protara’s business and financial
condition in general, including the risks and uncertainties
described more fully under the caption “Risk Factors” and elsewhere
in Protara's filings and reports with the United States Securities
and Exchange Commission. All forward-looking statements contained
in this press release speak only as of the date on which they were
made and are based on management's assumptions and estimates as of
such date. Protara undertakes no obligation to update any
forward-looking statements, whether as a result of the receipt of
new information, the occurrence of future events or otherwise,
except as required by law.
Company Contact:
Justine O'MalleyProtara
TherapeuticsJustine.OMalley@protaratx.com646-817-2836
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