Protara Therapeutics Announces Trials in Progress Poster Presentation for the ADVANCED-1 Trial in NMIBC at the 2022 American Society of Clinical Oncology Annual Meeting
May 26 2022 - 5:11PM
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 American Society of Clinical Oncology Annual Meeting being
held in Chicago, Illinois and virtually from June 3 through June 7,
2022. The ADVANCED-1 study is evaluating TARA-002, an
investigational cell-based immunopotentiator, for the treatment of
non-muscle invasive bladder cancer (NMIBC).
“There is a significant need for new treatment
options for patients with NMIBC, one of the most recurrent and
difficult to treat cancers,” said Jathin Bandari, M.D., Chief
Medical Officer of Protara Therapeutics. “Based on its
mechanism of action, and promising clinical data from its
predecessor therapeutic OK-432, we believe that TARA-002 may
address this pressing area of high unmet need. We look forward to
continuing to advance this trial and exploring TARA-002’s full
potential in NMIBC.”
Details of the poster presentation are as
follows:
Title: A Phase 1a/b safety
study of intravesical instillation of TARA-002 in adults with
high-grade non-muscle invasive bladder cancer (ADVANCED-1)
Abstract Number:
TPS4620Session Title: Genitourinary
Cancer—Kidney and BladderSession Date and
Time: Saturday, June 4, 2022, from 2:15 PM – 5:15 PM
EDTLocation: In-Person & Online | McCormick
Place, Hall A
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.A copy of the abstract is available at
https://meetings.asco.org.
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 a development path 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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