CURE Pharmaceutical Announces Positive Findings from Study at Cincinnati Children’s Hospital Medical Center (CCHMC) Using CURE’s Proprietary, Oral Thin Film (OTF) High, Single Dose Vitamin D in Pediatric Patients Pre- and Post-Hematopoietic Stem Cell Transplantation (HSCT)

Rhea-AI Summary

CURE Pharmaceutical Holdings (OTC: CURR) announced that its OTF Vitamin D, branded as ImmunD3™ Nutri-Strips™, outperformed standard supplementation in achieving vitamin D sufficiency in pediatric patients undergoing stem cell therapy. Conducted at Cincinnati Children’s Hospital Medical Center (CCHMC), the study demonstrated significant improvements in vitamin D levels, enhancing patient outcomes and reducing complications. CCHMC aims to include this innovative supplement in its formulary, with plans for broader adoption in children’s hospitals nationwide.

Positive

• CURE's ImmunD3 Nutri-Strips proved more effective than standard vitamin D supplements in pediatric patients undergoing stem cell therapy.
• The study showed significant improvement in median vitamin D levels from 29.4 ng/mL to 5.5 ng/mL, indicating better health outcomes.
• CCHMC is seeking to add CURE's Nutri-Strips to its hospital formulary, suggesting strong support from clinicians.
• The product overcomes barriers of conventional vitamin D therapy, improving compliance and patient preference.

Negative

• None.

• 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)
• 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:

• malabsorption secondary to gut GVHD
• the inability to take capsules
• Mucositis
• Kidney disease
• Liver disease
• 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.

Contacts:

Investor Relations
investor@curepharma.com
(805) 410-9962 ext. 4

FAQ

What are the findings of CURE's study on ImmunD3 Nutri-Strips?

The study found that CURE's ImmunD3 Nutri-Strips are more effective than standard vitamin D supplements in achieving necessary vitamin D sufficiency in pediatric patients before stem cell therapy.

How effective is CURE's Nutri-Strips in improving vitamin D levels?

Patients showed improvement in serum vitamin D levels, with median levels increasing significantly from 29.4 ng/mL to 5.5 ng/mL by week four of the study.

Is CURE's vitamin D supplement being added to hospital formularies?

Yes, Cincinnati Children’s Hospital Medical Center is working on adding CURE's ImmunD3 Nutri-Strips to its formulary, indicating positive clinical reception.

What are the advantages of CURE’s OTF Vitamin D over standard supplementation?

CURE's OTF Vitamin D formulation overcomes issues such as malabsorption and inability to take capsules, which are common in pediatric patients facing stem cell therapy.

What is the next step for CURE Pharmaceutical regarding its vitamin D product?

CURE plans to reach out to other children's hospitals across the U.S. to share findings and promote the addition of its ImmunD3 Nutri-Strips to their formularies.