Continued Advancements in Developing
Regenerative Therapeutics
While Maintaining Strong Financial Position
PHOENIX, June 12,
2023 /PRNewswire/ -- Creative Medical Technology
Holdings, Inc. ("Creative Medical Technology" or the "Company")
(NASDAQ: CELZ), a biotechnology company focused on a
regenerative approach to immunotherapy, endocrinology, urology,
gynecology, and orthopedics, today provided an update on recent
business activities.
"As we approach the mid-point of the year, we wanted to take
this opportunity to summarize recent clinical, regulatory, and
business developments," said Timothy
Warbington, Chief Executive Officer of Creative Medical
Technology. "Although we provided a similar update in April, we
believe that these incremental advancements further validate our
business model of pursuing the development of best-in-class
regenerative therapeutics that address multiple indications and
growing end markets. None of this would have been possible without
the hard work and dedication of our team, an extensive IP portfolio
with significant potential commercial applications, and a strong
financial position."
2023 Developments
Type 1 Diabetes
As previously announced, in November
2022 the U.S. Food and Drug Administration cleared the
Company's Investigational New Drug (IND) application, enabling the
Company to proceed with initiating a first in country Phase 1/2
clinical trial for Type 1 Diabetes using CELZ-201
(AlloStemTM). The Company received
Institutional Review Board (IRB) approval to proceed with its
clinical trial in February 2023,
announced the engagement of Syneos Health as the contract research
organization for this trial in March
2023, and has the updated recruiting trial status at
ClinicalTrials.gov.
In March, the Company announced the FDA filing for an Orphan
Drug Designation (ODD) treatment of Type 1 Brittle Diabetes
utilizing our ImmCelz® product in conjunction with islet
transplantation. In discussions with FDA we are fortified in our
belief that the ImmCelz® Program in addition to T1D islet
transplantations, has the ability to expand to multiple other cell
and organ transplants to treat or reduce rejection. Such
discussions have led to the acceleration of the ImmCelz® program
with the intent to file an ImmCelz® IND in the latter part of 2023,
while continuing with the ODD for Brittle Diabetes.
Type 2 Diabetes
In April 2023, the Company
announced positive follow-up data and significant efficacy
using CELZ-001 cells to treat patients with Type 2
Diabetes.
At a six-month follow up, there were no safety concerns related
to CELZ-001 utilizing the same infusion procedure as in the current
U.S. FDA cleared CELZ-201 clinical trial for Type 1 Diabetes, and
an overall efficacy of 93% was reported in the treated patients
demonstrating at least a 50% reduction in insulin requirement.
Chronic Lower Back Pain
In May, the Company announced positive top line pilot study
results for the StemSpine® procedure using AlloStem™ to
treat chronic lower back pain. This patented procedure
utilizes AlloStemTM, an "off the shelf, ready-to-use"
universal and proprietary allogenic (donor) cell developed by the
Company.
The data demonstrated a greater than 90% reduction in narcotic
usage, greater than 80% reduction in pain score, and greater than
50% reduction in the Oswestry Score in the treated patients.
No patients required re-dosage or surgical intervention at the
primary end point of six months and there were no safety related
concerns. To the Company's knowledge, this pilot study is the
first to demonstrate safety and clinical efficacy of injecting
donor cells in areas surrounding the disc, thereby potentially
repairing, remodeling, and improving the blood supply around the
disc and lower back area. Further translation of the StemSpine
procedure may help to alleviate the current opioid crisis by
offering additional, non-surgical options to patients who suffer
from chronic lower back pain.
Next Milestone Achievement in ImmCelz® Platform Development
In May, the Company announced significant advancements in the
ongoing development of its ImmCelz® (CELZ-100) platform, a
cell-free system which has previously been validated to supercharge
a patient's own cells to treat a number of immune
disorders.
Independent studies confirmed that the ImmCelz® platform:
required 75% fewer donor patient cells compared to industry
standard; possessed purity of greater than 95% compared to the
industry standard of greater than 80%; and demonstrated
a greater than 200% reduction in functional suppression of effector
T cells, which are a critical concern for patients with autoimmune
issues, while still possessing a high number of functional T
regulatory cells.
The Company believes that the ability to reduce the number of
required donor patient cells while simultaneously producing a more
effective product allows for the ability to reach a greater number
of potentially sicker patients. It may also potentially allow
the Company to offer and treat even a wider variety of immune
disorders that require multiple dosing strategies while maintaining
patient safety.
Next Generation iPSC Pipeline for ImmCelz® Immunotherapy
Platform
In May 2023, the Company announced
that it had received confirmation that Greenstone Biosciences
Inc. has successfully developed a human induced pluripotent
stem cell (iPSC) pipeline for the Company's ImmCelz®
platform. In June 2022, the
Company announced its collaboration with Greenstone Biosciences
Inc. on this project, called the iPScelzTM program.
This collaboration and the associated development of this cell
line is expected to enable the Company to increase the scalability
for the ImmCelz® Immunotherapy Platform, save two to three years in
research and development time along with associated expenses, and
accelerate its drug discovery program using artificial
intelligence.
Reverse Stock Split
As previously announced, the Company's Board of Directors
approved a 1 for 10 reverse stock split of its shares of common
stock that becomes effective at 9:00 a.m.
Eastern time on June 12,
2023.
Mr. Warbington commented, "We wish to emphasize that this action
was undertaken for the sole purpose of bringing the Company into
compliance with The Nasdaq Capital Market's $1.00 minimum price requirement. We believe that
maintaining our listing on Nasdaq is an important component of our
business development and makes our equity more attractive to a
broader range of investors. We continue to look forward to
our future with confidence and optimism."
Financial Position
On March 31, 2023, the Company
reported cash and certificates of deposit of $14.6 million, working capital of $14.4 million, and no long-term debt. The
Company calculates that it has more than sufficient funds
to meet its anticipated operating costs and capital expenditure
requirements through 2024, therefore no additional capital will be
sought at this time. Our number of shares of common stock
outstanding following the effect of the reverse stock split is
approximately 1.4 million.
About Creative Medical Technology Holdings
Creative
Medical Technology Holdings, Inc. is a biotechnology company
dedicated to the advancement of identifying and translating novel
biological therapeutics in the fields of immunotherapy,
endocrinology, urology, gynecology, and orthopedics and is traded
on NASDAQ under the ticker symbol CELZ. For further information
about the Company, please
visit www.creativemedicaltechnology.com.
Forward Looking Statements
This news release may
contain forward-looking statements including but not limited to
comments regarding the timing and content of upcoming clinical
trials and laboratory results, marketing efforts, funding, etc.
Forward-looking statements address future events and conditions
and, therefore, involve inherent risks and uncertainties. Actual
results may differ materially from those currently anticipated in
such statements. See the periodic and other reports filed by
Creative Medical Technology Holdings, Inc. with the Securities and
Exchange Commission and available on the Commission's website at
www.sec.gov.
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SOURCE Creative Medical Technology Holdings, Inc.