Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company
focused on developing potential first-in-class restorative
therapeutics that ignite the body’s natural process to repair and
maintain healthy biological function, has been awarded a $2 million
grant by the Peer Reviewed Orthopedic Research Program (PRORP) of
the U.S. Department of Defense (DoD) to help fund a Phase 1/2
clinical trial of HST-003 for regeneration of cartilage in the
knee. The U.S. Army Medical Research Acquisition Activity, 820
Chandler Street, Fort Detrick MD 21702, is the awarding and
administering acquisition office.
The Phase 1/2 clinical trial is designed to
evaluate HST-003 in combination with a microfracture procedure in
15 civilian and military patients with recent focal cartilage
defects in the knee caused by injury. Patients will be enrolled at
three clinical sites: OasisMD in San Diego, CA, The Steadman Clinic
in Vail, CO and Walter Reed Medical Center in Bethesda, MD. In
addition to safety parameters, endpoints will include traditional
scores for pain and joint function from The Knee Injury and
Osteoarthritis Outcome Scores (KOOS) and The International Knee
Documentation Committee (IKDC), as well as an MRI to quantify
cartilage regeneration.
“The Steadman Clinic is world renowned for our
dedication to excellence in treating orthopedic defects and we are
excited about being a clinical center for studying Histogen’s human
extracellular matrix, or hECM, for focal lesions of the knee,” said
Matthew Provencher MD, CAPT, MC, USNR. “Regenerating uniform
functional hyaline cartilage is critical to restoring normal
function for military personnel and civilians alike.”
“Lesions in articular knee cartilage can cause
considerable morbidity and current surgical options may result in
uneven repair and a scar-like fibrous cartilage instead of the
normal hyaline cartilage that provides the greatest long-term
function,” said Dr. Gail K. Naughton, Histogen Founder and CSO.
“Histogen’s HST-003 has demonstrated hyaline cartilage regeneration
in three different in vivo animal models conducted by orthopedic
experts. It is an honor to have been granted an award from the DoD
to support our HST-003 Phase 1/2 trial,” concluded Dr.
Naughton.
There is a significant need for improved acute
knee injury treatments in both military and civilian populations.
Approximately 900,000 Americans are affected by knee cartilage
injuries annually, with 200,000 requiring surgical interventioni.
Further, among US military personnel, musculoskeletal injuries are
a leading cause of morbidity, lost training time and reduced
operational readiness, resulting in as many as 2.4 million health
visits and 25 million limited-duty days per yearii.
”These non-dilutive funds will support our
efforts to clinically evaluate the safety and efficacy of our novel
cartilage repair treatment which has applicability in both the
military and civilian populations,” said Richard W. Pascoe,
Histogen’s President and CEO. “As a former soldier, I understand
that the health and readiness of our servicemembers is essential to
our national defense. We are pleased to partner with the DoD and
these prestigious clinical sites to advance HST-003 into the clinic
in support of that effort.”
The views expressed in this press release are those of the
author and may not reflect the official policy or position of the
Department of the Army, Department of Defense, or the U.S.
Government.
About HST-003Histogen’s human
extracellular matrix, or hECM, is intended for regenerating hyaline
cartilage for the treatment of articular cartilage defects with a
novel malleable scaffold that stimulates the body’s own stem cells.
In multiple preclinical models, HST-003 has been
shown to regenerate mature cartilage and well vascularized bone,
indicating great therapeutic potential in the sports medicine,
spinal disc repair, orthopedic, and dental areas. Studies conducted
by outside experts have demonstrated that HST-003 is
anti-inflammatory, angiogenic, and can stimulate the growth of stem
cells in damaged areas to induce tissue regeneration. The most
extensive in vivo work in animals has focused on the regeneration
of new hyaline cartilage and bone in full thickness knee
injuries.
About HistogenHistogen Inc. is
a clinical-stage therapeutics company focused on developing
potential first-in-class restorative therapeutics that ignite the
body’s natural process to repair and maintain healthy biological
function. Histogen’s innovative technology platform utilizes cell
conditioned media and extracellular matrix materials produced by
hypoxia-induced multipotent cells. Histogen’s proprietary,
reproducible manufacturing process provides targeted solutions
across a broad range of therapeutic indications including hair
growth, dermal rejuvenation, joint cartilage regeneration and
spinal disk repair. For more information, please
visit www.histogen.com.
Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the “safe harbor” provisions of the Private Securities
Litigation Reform Act of 1995 and other Federal securities laws.
For example, we are using forward-looking statements when we
discuss Histogen’s future operations and its ability to
successfully initiate and complete clinical trials and achieve
regulatory milestones and related timing, including those related
to the planned Phase 1/2 clinical trial of HST-003 for regeneration
of cartilage in the knee; the nature, strategy and focus of
Histogen’s business; and the development and commercial potential
and potential benefits of any of Histogen’s product candidates.
Histogen may not actually achieve the plans, carry out the
intentions or meet the expectations or projections disclosed in the
forward-looking statements and you should not place undue reliance
on these forward-looking statements. Because such statements deal
with future events and are based on Histogen’s current
expectations, they are subject to various risks and uncertainties
and actual results, performance or achievements of Histogen that
could differ materially from those described in or implied by the
statements in this press release, including: the uncertainties
associated with the clinical development and regulatory approval of
Histogen’s product candidates, including potential delays in the
commencement, enrollment and completion of clinical trials such as
the planned Phase 1/2 clinical trial of HST-003 for regeneration of
cartilage in the knee; the potential that earlier clinical trials
and studies of Histogen’s product candidates may not be predictive
of future results; risks related to business interruptions,
including the outbreak of COVID-19 coronavirus, which could
seriously harm Histogen’s financial condition and increase its
costs and expenses; and the requirement for additional capital to
continue to advance these product candidates, which may not be
available on favorable terms or at all. The foregoing review of
important factors that could cause actual events to differ from
expectations should not be construed as exhaustive and should be
read in conjunction with statements that are included herein and
elsewhere, including those risks discussed in Histogen’s filings
with the Securities and Exchange Commission. Except as otherwise
required by law, Histogen disclaims any intention or obligation to
update or revise any forward-looking statements, which speak only
as of the date hereof, whether as a result of new information,
future events, or circumstances or otherwise.
i Merkely, G., Ackermann, J. & Lattermann,
C. Articular Cartilage Defects: Incidence, Diagnosis, and Natural
History. Oper. Tech. Sports Med. 26, 156–161 (2018).
ii Teyhen, D. S., Goffar, S. L., Shaffer, S. W.,
Kiesel, K., Butler, R. J., Tedaldi, A.-M., Prye, J. C., Rhon, D. I.
& Plisky, P. J. Incidence of Musculoskeletal Injury in US Army
Unit Types: A Prospective Cohort Study. J. Orthop. Sports Phys.
Ther. 48, 749–757 (2018).
CONTACT:
Susan A. KnudsonExecutive Vice President &
CFO Histogen, Inc. ir@histogen.com
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