CALADRIUS BIOSCIENCES, INC. (NASDAQ:CLBS) Files An 8-K Other Events
Item 8.01 Other Events.
On February 13, 2019, Caladrius Biosciences, Inc. (the “Company”) issued a press release in connection with results announced 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 one-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). A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statement and Exhibits.
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Exhibit No. |
Description |
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Press release, dated February 13, 2019 |
CALADRIUS BIOSCIENCES, INC. Exhibit
EX-99.1 2 exhibitpressrelease021319.htm EXHIBIT 99.1 Exhibit Exhibit 99.1Caladrius Biosciences Reports Top-Line Data for the Phase 2a Sanford Project: T-Rex Trial of CLBS03 for Recent Onset Type 1 DiabetesBASKING RIDGE,…
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About CALADRIUS BIOSCIENCES, INC. (NASDAQ:CLBS)
Caladrius Biosciences, Inc., formerly NeoStem, Inc., through its subsidiary, PCT, LLC, a Caladrius Company (PCT), provides development and manufacturing services to the cell therapy industry (which includes cell-based gene therapy). PCT specializes in cell and cell-based gene therapies. PCT offers development and manufacturing capabilities, quality systems, cell and tissue processing, logistics, storage and distribution and engineering solutions to clients with therapeutic candidates at all stages of development. The Company’s product candidate, CLBS03, is a T regulatory cell (Treg) clinical Phase II therapy targeting adolescents with recent-onset type 1 diabetes mellitus (T1DM) using the patient’s own numerically and functionally enhanced Tregs. This therapy is based on a platform technology for immunomodulation. The Company’s T Regulatory Cell Technology is applicable to multiple autoimmune and allergic diseases.
