JUPITER,
Fla., July 15, 2024 /PRNewswire/ -- Cytonics
Corporation, a private biotechnology company developing biologic
therapies for musculoskeletal ailments, today announced initiation
of enrollment for its Phase 1 clinical study of CYT-108, a
recombinant variant of the alpha-2-macroglobulin blood serum
protein, targeting proteases responsible for cartilage degradation
in osteoarthritis (OA). CYT-108 was engineered for increased
protease-inhibition activity against the major classes of proteases
that are responsible for the majority of cartilage catabolism in
arthritic joints, while maintaining its broad-spectrum
anti-protease activity against serine and threonine proteases.
![Cytonics Corporation Cytonics Corporation](https://mma.prnewswire.com/media/2459765/Cytonics_Corporation_Logo.jpg)
"Our first-in-human clinical trial is the culmination of 6
years of preclinical R&D, during which we overcame many
technical challenges in developing our recombinant A2M variant,
CYT-108," said Joey Bose,
President & CEO of Cytonics. "The massive size of the
engineered protein (720kD) and complex folding structure made GMP
production a scientific feat, and the ingenuity and experience of
Lewis Hanna, PhD, our Chief
Scientific Officer allowed us to surmount this incredible technical
challenge. The preclinical data is compelling, demonstrating signs
of CYT-108's protective capabilities not only in the cartilage
tissue, but in multiple other joint physiologies that are involved
in the pathogenesis of osteoarthritis. Furthermore, we believe that
the development of CYT-108 is de-risked by the clinical and
commercial success of our first-generation OA therapy, the
Autologous Protease Inhibitor Concentrate (APIC) medical device,
which has treated over 8,000 patients using autologous A2M
selectively concentrated from their own blood."
The Phase 1 study is designed to assess CYT-108's tolerability
and efficacy in patients suffering from primary osteoarthritis of
the knee. A single dose of the drug will be administered
intra-articularly at two timepoints, 90 days apart. Patients will
be monitored every few weeks for an additional 90 days to evaluate
safety, pharmacokinetics, and efficacy in reducing joint pain,
stiffness, and mobility limitations.
About CYT-108
CYT-108 is a recombinant variant of the endogenous
alpha-2-macroglobulin (A2M) blood serum protein. The "bait" region
of the protein, which serves as a substrate for proteases, was
engineered to increase its affinity for specific proteases that are
known to play a significant role in the molecular pathogenesis of
osteoarthritis. The combination of both highly specific and
broad-spectrum protease inhibition activity of CYT-108
differentiates this novel biologic from other attempts to develop
small molecule inhibitors that target single proteases,
positioning CYT-108 as an ideal disease-modifying candidate
for osteoarthritis. The development of CYT-108 is predicated on the
success of Cytonics' first-generation therapy, the Autologous
Protease Inhibitor Concentrate (APIC) system, which is a 510(k)
medical device that selectively enriches autologous A2M for
intra-articular injection into joints containing articular
cartilage (knee, shoulder, spine, hip, etc.). The clinical and
commercial success of APIC uniquely de-risks the development of
CYT-108 because it is already understood that high concentrations
of A2M can be introduced into arthritic joints without significant
side effects, and the treatment has achieved clinical and
commercial success since it was first cleared by the FDA as a
510(k) device and sold in 2015.
About Cytonics Corp.
Cytonics, founded in 2006, is a private research and development
company focused on developing molecular diagnostics and
therapeutics for chronic musculoskeletal diseases such as
osteoarthritis. The company's flagship product was a diagnostic
test (the Fibronectin-Aggrecan Complex Test, FACT) which helps
identify the source of joint pain and assists physicians in
determining the most appropriate course of treatment. Cytonics then
developed the Autologous Platelet-Integrated Concentrate (APIC)
system which concentrates a therapeutic blood protein, A2M, from
patients' own blood and injects the A2M-rich concentrate into
damaged joints. APIC has been used to treat over 8,000 patients
nationwide, saving thousands of patients from invasive joint
replacement surgeries. The company has raised over $25M in private funding and was awarded
$1.8M in grants from the NIH to
pursue their innovative research. The company is currently pursuing
Phase 1 clinical studies for their lead drug candidate, CYT-108, a
recombinant variant of the endogenous alpha-2-macroglobulin
protease inhibitor. If approved, CYT-108 may be the first and only
disease-modifying therapy for osteoarthritis.
Forward Looking Statements
This release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995
including statements regarding the progress of and plans related to
the Company's product candidates, clinical studies and preclinical
research and development programs, the therapeutic and market
potential of the Company's research and development programs and
product candidates, the Company's clinical and product development
strategy, and the Company's expectations regarding progress and
timelines. These and any other forward-looking statements in this
release are based on management's current expectations of future
events and are subject to a number of risks and uncertainties that
could cause actual results to differ materially and adversely from
those set forth in or implied by such forward-looking statements.
These risks and uncertainties include, but are not limited to, the
risk that the Company's research and development programs and
product candidates may not demonstrate the requisite safety,
efficacy, or other attributes to warrant further development or to
achieve regulatory approval, the risk that results observed in
prior studies of the Company's product candidates, including
preclinical studies and clinical trials, will not be observed in
ongoing or future studies involving these product candidates, the
risk of a delay or difficulties in the manufacturing of the
Company's product candidates or in the initiation and conduct of,
or enrollment of patients in, any clinical trials, the risk that
the Company may cease or delay preclinical or clinical development
of any of its product candidates for a variety of reasons
(including requirements that may be imposed by regulatory
authorities on the initiation or conduct of clinical trials,
changes in the therapeutic, regulatory, or competitive landscape
for which the Company's product candidates are being developed, the
amount and type of data to be generated or otherwise to support
regulatory approval, difficulties or delays in patient enrollment
and continuation in the Company's ongoing and planned clinical
trials, difficulties in manufacturing or supplying the Company's
product candidates for clinical testing, and any adverse events or
other negative results that may be observed during preclinical or
clinical development), the risk that its product candidates may not
produce therapeutic benefits or may cause other unanticipated
adverse effects, and the risk that the Company may incur operating
expenses in amounts greater than anticipated. For a discussion of
other risks and uncertainties, and other important factors, any of
which could cause the Company's actual results to differ from those
contained in the forward-looking statements, see the risks and
uncertainties detailed in the Company's periodic filings with the
Securities and Exchange Commission
(https://www.sec.gov/edgar/browse/?CIK=0001421744), including but
not limited to the Company's most recently filed periodic report,
and from time to time in the Company's press releases and other
investor communications. Cytonics Corporation is providing the
information in this release as of this date and does not undertake
any obligation to update any forward-looking statements contained
in this release as a result of new information, future events or
otherwise.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/cytonics-announces-initiation-of-first-in-human-phase-1-clinical-study-for-cyt-108-in-patients-suffering-from-osteoarthritis-of-the-knee-302196027.html
SOURCE Cytonics Corporation