Protara Therapeutics Announces FDA Clearance of Investigational New Drug Application for TARA-002 for the Treatment of Non-Muscle Invasive Bladder Cancer
October 12 2021 - 7:00AM
Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company
developing transformative therapies for the treatment of cancer and
rare diseases, today announced the U.S. Food and Drug
Administration (FDA) has cleared the Company’s Investigational New
Drug (IND) application for TARA-002, an investigational cell-based
therapy being developed for the treatment of non-muscle invasive
bladder cancer (NMIBC). Protara expects to initiate a Phase 1
clinical trial of TARA-002 in adults with high-grade NMIBC by the
end of 2021.
“We are thrilled to have reached this important milestone and
look forward to quickly initiating our Phase 1 study in patients
with NMIBC,” said Jesse Shefferman, Chief Executive Officer of
Protara Therapeutics. “There is an urgent need for new treatments
for NMIBC. We are seeing significant increases in recurrence and
disease progression, as well as an escalating number of patients
requiring cystectomies. Supported by the strength of the existing
clinical data in NMIBC for OK-432, the originator therapy for
TARA-002, we believe this treatment represents a promising new
option for NMIBC patients.”
The Phase 1 dose-finding, open-label trial will evaluate
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 maximum tolerated dose
and recommended dose for a future Phase 2 clinical trial.
TARA-002 is manufactured from the same cell bank as OK-432, an
approved therapy in Japan and Taiwan for multiple oncologic
indications. In 2020, Protara successfully demonstrated initial
manufacturing comparability between TARA-002 and OK-432. The
confirmatory, GMP-scale comparability data for TARA-002 in relation
to OK-432 have been completed and were reviewed by FDA as part of
the clearance of the IND.
About TARA-002TARA-002 is an investigational
cell therapy in development for the treatment of non-muscle
invasive bladder cancer and lymphatic malformations (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.
Protara has successfully demonstrated manufacturing comparability
between TARA-002 and OK-432.
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-6, IL-8, IL-12, interferon-gamma
(IFN-γ)-, tumor necrosis factor-alpha (TNF-α), and vascular
endothelial growth factor (VEGF) 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 non-clinical studies and clinical
trials, and statements regarding the anticipated safety or efficacy
of Protara’s product candidates. 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 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; 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; 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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