Protara Therapeutics Doses First Patient in ADVANCED-1 Phase 1 Study of TARA-002 in Non-Muscle Invasive Bladder Cancer
March 24 2022 - 8:00AM
Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage
company developing transformative therapies for the treatment of
cancer and rare diseases, today announced that the Company has
dosed the first patient in ADVANCED-1, its Phase 1 clinical trial
evaluating TARA-002, an investigational cell-based
immunopotentiator, for the treatment of non-muscle invasive bladder
cancer (NMIBC).
“NMIBC is one of the most recurrent and
difficult to treat cancers with very limited treatment options,”
said Jesse Shefferman, Chief Executive Officer of Protara
Therapeutics. “We are thrilled to have dosed the first patient in
our Phase 1 study in NMIBC and look forward to exploring TARA-002’s
full potential in this pressing area of high unmet need.”
ADVANCED-1 is a Phase 1 dose-finding, open-label
trial (NCT05085977) 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.
“While bladder cancer is the 6th most common
cancer in the United States today, with NMIBC
representing approximately 80% of diagnoses, treatment options for
these patients remain limited,” said Edward M. Messing, M.D.,
Professor of Urology, Oncology and Pathology at the University of
Rochester, and a principal investigator for the study. “There is an
urgent need for new therapeutic interventions for these patients,
as there continues to be an increase in recurrence, progression and
an escalated number of patients needing cystectomies.”
About TARA-002TARA-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. 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-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 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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