Caladrius Biosciences Reports Top-Line Data for the Phase 2a Sanford Project: T-Rex Trial of CLBS03 for Recent Onset Type 1 D...
February 13 2019 - 5:26PM
Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the
“Company”), a late-stage therapeutics development biopharmaceutical
company with multiple development programs targeting select
cardiovascular indications and autoimmune disease, today
announced top-line results from The Sanford Project: T-Rex
Study, a prospective, randomized, placebo-controlled, double-blind
Phase 2a clinical trial of 110 subjects to evaluate the safety and
efficacy of the Company’s CLBS03 as a treatment for recent-onset
type 1 diabetes (“T1D”) in adolescents. The initial analysis
of the 1-year follow-up data for all subjects shows that CLBS03 was
well tolerated at the doses tested in the study (targeting 2.5
million cells/kg or 20 million cells/kg); however, no improvement
in the primary endpoint of preservation of C-peptide levels vs.
placebo at 1 year was observed at the group level (using the
standard mixed meal tolerance test). As with many Phase 2a
trials, the database from this study is very large and the analysis
and interpretation of all the information will require several
months of intensive evaluation and will be critical to the decision
regarding the next steps in development of CLBS03. In
addition, the data from the 2-year follow-up, once complete, will
afford supplemental information and are necessary to complete the
evaluation of this therapy.
“Given the heterogeneity of the patient population and disease
progression rates of type 1 diabetes, it is not surprising that the
cohort analysis in the study did not yield a positive result.
Thorough examination and review of the complete database
undoubtedly will uncover additional findings and will inform us on
the next steps in development of CLBS03 in this indication,” stated
David Pearce, Ph.D., President of Innovation and Research at
Sanford Health.
“We look forward to working with our research partner, Sanford
Research, as well as with the distinguished panel of investigators
and key opinion leaders in the field of type 1 diabetes to explore
and understand the data from this study to its full extent,”
remarked David J. Mazzo, Ph.D., President and CEO of Caladrius
Biosciences. Dr. Mazzo added, “As we’ve previously stated, we
believe that the results from the T-rex study will yield a
treasure-trove of information that will add materially to the
understanding of T regulatory cells and their role in autoimmune
disease and we look forward to seeing that information shared in
the future. Finally, we express sincere gratitude to the
patients, their parents and the investigators who were part of this
study and we recognize that our development efforts could not have
advanced without their participation.”
About the Sanford Project: T Rex StudyThe
landmark T-rex study, which was conducted in collaboration with
Sanford Research, a Sanford Health subsidiary, was a prospective,
randomized, placebo-controlled, double-blind Phase 2a clinical
trial to evaluate the safety and efficacy of CLBS03 as a treatment
for T1D in approximately 110 subjects age 8 to 17 with recent-onset
T1D. Subjects were randomized into one of three groups to
receive, through a single administration, either a high dose of
CLBS03, a low dose of CLBS03 or placebo. The key endpoints for the
trial were the standard medical and regulatory endpoints for a T1D
trial and include preservation of C-peptide (an accepted measure
for pancreatic beta cell function), insulin use, severe
hypoglycemic episodes and glucose and hemoglobin A1c levels. For
more information on The Sanford Project: T‑Rex Study, please
visit https://clinicaltrials.gov/ct2/show/NCT02691247.
About Caladrius BiosciencesCaladrius is a
late-stage therapeutics development biopharmaceutical company
committed to the development of innovative products that have the
potential to restore the health of people with chronic illnesses.
Our leadership team collectively has decades of biopharmaceutical
development experience and world-recognized scientific achievement
in the fields of cardiovascular and autoimmune disease, among other
areas. The Company’s goal is to build a broad portfolio of novel
and versatile products that address important unmet medical needs.
In addition to CLBS03, our current product candidates include three
developmental treatments for cardiovascular diseases based on our
CD34 cell therapy platform: CLBS12, recipient of SAKIGAKE
designation, in Phase 2 testing in Japan and eligible for early
conditional approval for the treatment of critical limb ischemia;
CLBS14-CMD, in Phase 2 testing for the treatment of coronary
microvascular dysfunction and CLBS14-NORDA (formerly CLBS14-RfA) in
late-stage development for no option refractory disabling angina
for which it has received RMAT designation. For more information on
the company, please visit www.caladrius.com.
Safe Harbor for Forward Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements reflect management’s current
expectations, as of the date of this press release, and involve
certain risks and uncertainties. All statements other than
statements of historical fact contained in this press release are
forward-looking statements. The Company’s actual results could
differ materially from those anticipated in these forward-looking
statements as a result of various factors. Factors that could cause
future results to differ materially from the recent results or
those projected in forward-looking statements include the “Risk
Factors” described in the Company’s Annual Report on Form 10-K
filed with the Securities and Exchange Commission (“SEC”) on March
22, 2018, as subsequently amended on April 2, 2018, and in the
Company’s other periodic filings with the SEC. The Company’s
further development is highly dependent on, among other things,
future medical and research developments and market acceptance,
which are outside of its control. You are cautioned not to place
undue reliance on forward-looking statements, which speak only as
of the date of this Press Release. Caladrius does not intend, and
disclaims any obligation, to update or revise any forward-looking
information contained in this Press Release or with respect to the
matters described herein.
Contacts:Investors: Caladrius Biosciences, Inc.
John Menditto Vice President, Investor Relations and Corporate
Communications Phone: +1-908-842-0084
Email: jmenditto@caladrius.com
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