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CURE’s Patented and Proprietary OTF Vitamin D Found
to be More Effective than Standard Supplementation
in Achieving pre- and post-Surgery Vitamin D
Sufficiency Necessary to Reduce Immune-Mediated
Damage such as Graft Versus Host Disease (GVHD)
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CCHMC to Seek Formulary approval for CURE’s OTF
Vitamin D Supplement in its Hospital Formulary
OXNARD, Calif., May 12, 2022 (GLOBE NEWSWIRE) -- CURE
Pharmaceutical Holdings (OTC: CURR), a developer and
manufacturer of innovative delivery formulations for
drugs, supplements and wellness products, today
announced positive finding from a study conducted at
Cincinnati Children’s Hospital Medical Center (CCHMC)
using CURE’s proprietary, single dose, oral, 40,000 IU
vitamin D (branded ImmunD3™ Nutri-Strips™ in the retail
wellness market) in pediatric patients before stem cell
therapy. CURE’s oral Vitamin D supplement was found to
be more effective than standard supplementation in
achieving pre- and post-surgery vitamin D sufficiency,
which is critical for reducing immune-mediated organ
damage in the children receiving HSCT.
To
view the details of this study, visit the poster
presentation on CURE’s website at https://curepharmaceutical.com/white-papers/
“The findings for our proprietary, oral thin film
Vitamin D, which we brand as ImmunD3 NutriStrips, is
quite remarkable for its ability to improve bone health
and reduce complications in pediatric patients and
brings additional hope to the parents and their children
who undergo HSCT stem cell therapy, for life-threatening
diseases,” said CURE Pharmaceutical CEO Rob Davidson.
“If we can reduce the risks of complications by bringing
these children up to optimal Vitamin D levels before
surgery, and in the acute post-transplantation period,
we’ve helped to reduce pain and suffering and
potentially saved lives.”
Next Steps: Adding CURE’s oral Vitamin D to Formularies
Nationwide
Since previous attempts to improve vitamin D deficiency
in these young patients using additional doses and/or
higher dosing of enteral vitamin D are often not
successful, CCHMC is working with its Formulary to add
CURE’s NutriStrip Vitamin D formulation to its list of
approved treatments.
Davidson added: “We are also pleased that the CCHMC team
found these results to be so compelling as to commence
the process to include what we call “ImmunD3
Nutri-Strips™” in their hospital’s Formulary. In light
of this advancement, we plan to reach out to other
children’s hospitals around the U.S. in order to share
these compelling findings and seek the addition of our
proprietary Vitamin D into their Formularies.”
Using CURE’s proprietary delivery technology is
important because it overcomes the numerous barriers
that impede adequate replacement with conventional
vitamin D therapy. Some of these obstacles include:
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malabsorption secondary to gut GVHD
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the inability to take capsules
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Mucositis
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Kidney disease
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Liver disease
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Infection
More About the Study
The CCHMC study found that compliance and tolerance
likewise improved, with patients and parents expressing
a preference for the strips. The median age of the study
cohort was 8 years, with a range of 1-28 years old,
dosing varied significantly, from 1 strip monthly to 4
strips weekly and all patients showed improvement in
serum vitamin D levels by week 4 on study. The median
vitamin D level at baseline was 29.4 ng/mL,
significantly improved (p Median vitamin D level at
baseline was 29.4 ng/mL, significantly improved (p
0.0001) to 5.5ng/mL at the end of the study).
About Vitamin D and Pediatric Hematopoietic Stem Cell
Transplantation Patients
Vitamin D is essential for bone health and has
immunomodulatory properties. Most pediatric patients are
vitamin D insufficient (<30 ng/mL) before HSCT. Standard
supplementation strategies fail to achieve vitamin D
sufficiency in the acute post-transplantation period,
and there are scarce data to support optimal vitamin D
supplementation in this patient population. This study,
the poster of which can be found here: https://curepharmaceutical.com/white-papers/ sought
to evaluate whether a single, oral, weight-based
ultra-high dose of vitamin D was more effective than
standard supplementation in achieving pre-HSCT vitamin D
sufficiency and reducing the incidence of HSCT-related
complications (acute graft-versus-host disease,
veno-occlusive disease, and/or transplant-associated
thrombotic microangiopathy) that are associated with
immune-mediated endothelial damage. Secondary endpoints
examined the immunomodulatory properties of vitamin D.
About CURE Pharmaceutical
CURE Pharmaceutical ® is
the pioneering developer of CUREform™, a patented drug
delivery platform that offers a number of unique
immediate- and controlled-release drug delivery vehicles
designed to improve drug efficacy, safety, and patient
experience for a wide range of active ingredients. Among
CURE’s key products is its oral thin film, 40,000 IU
dose Vitamin D, (Branded Nutri-Strips™ in the Retail
Market). Each strip is hermetically sealed in airtight,
grab-and-go packaging to eliminate chemical and
structural breakdown and provide superior potency.
Nutri-Strips™ are available online at https://www.nutristripnow.com/immund3
As a vertically integrated company, CURE’s 25,000 square
foot, FDA-registered, NSF ® and
cGMP-certified manufacturing facility enables it to
partner with pharmaceutical and wellness companies
worldwide for private and white-labeled production. CURE
has partnerships in the U.S., China, Mexico, Canada,
Israel, and other markets in Europe.
Forward Looking Statements
Statements CURE makes in this press release may include
statements which are not historical facts and are
considered forward-looking within the meaning of Section
27A of the Securities Act of 1933, as amended
(“Securities Act”), and Section 21E of the Securities
Exchange Act of 1934, as amended (“Exchange Act”), which
are usually identified by the use of words such as
“anticipates,” “believes,” “estimates,” “expects,”
“intends,” “may,” “plans,” “projects,” “seeks,”
“should,” “will,” and variations of such words or
similar expressions. CURE intends these forward-looking
statements to be covered by the safe harbor provisions
for forward-looking statements contained in Section 27A
of the Securities Act and Section 21E of the Exchange
Act and is making this statement for purposes of
complying with those safe harbor provisions. The
forward-looking statements in this press release reflect
CURE’s judgment as of the date of this press release.
CURE disclaims any intent or obligation to update these
forward-looking statements.