Regen BioPharma, Inc. Expands Vision for Phase 1 Clinical Trial of HemaXellerate™

Rhea-AI Summary

Regen BioPharma (RGBP) has provided updates on its planned Phase 1 clinical trial for HemaXellerate™, a stem cell-derived therapy that received FDA clearance. The therapy aims to stimulate bone marrow regeneration, initially targeting aplastic anemia with potential expansion into chemotherapy-induced bone marrow suppression. The company has partnered with a specialized CRO to conduct the trial, which is expected to complete within 12-14 months. The targeted market for chemotherapy-induced bone marrow suppression is valued at over $1 billion annually.

Positive

• FDA clearance received for HemaXellerate™ Phase 1 clinical trial
• Potential market expansion into $1B+ chemotherapy-induced bone marrow suppression sector
• Partnership established with specialized CRO for trial execution
• Clear timeline established: 12-14 months for trial completion
• Opportunity for accelerated regulatory pathways due to rare disease status

Negative

• Early-stage development (Phase 1) indicates long path to commercialization
• No revenue generation in immediate future
• Competition from established products like Neulasta in target market

Targeting Transformative Solutions for Aplastic Anemia and Beyond

SAN DIEGO, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Regen BioPharma, Inc. (OTC Pink: RGBP and RGBPP) today provided further insight into its planned Phase 1 clinical trial of HemaXellerate^™, the company’s innovative stem cell-derived therapy, which has already received FDA clearance. While the initial focus is on treating aplastic anemia, Regen BioPharma is evaluating expanded applications for this groundbreaking therapy in a market poised for significant growth.

HemaXellerate^™ is designed to stimulate bone marrow regeneration following injury caused by autoimmune conditions, chemotherapy, or radiation. While the company’s initial target is aplastic anemia—a rare orphan indication—it sees substantial potential in treating chemotherapy-induced bone marrow suppression, a market valued at over $1 billion annually. This is evidenced by the success of products like Neulasta, which addresses similar unmet needs.

“Aplastic anemia patients without access to bone marrow transplantation face limited options,” said Dr. David Koos, Chairman and CEO of Regen BioPharma. “With FDA clearance to begin clinical trials, HemaXellerate^™ has the potential to redefine the treatment landscape—not just for aplastic anemia but for a wide range of hematological disorders. This is a pivotal moment for our company as we work to deliver life-changing therapies to patients worldwide.”

To ensure the trial’s success, Regen BioPharma has partnered with a clinical research organization (CRO) known for its expertise in conducting complex trials. Once initiated, the study is expected to reach completion within 12 to 14 months.

Key Highlights for Investors:

• Opportunity: Aplastic anemia is a rare disease with high unmet medical need, offering the potential for accelerated regulatory pathways and market exclusivity.
• Massive Market Potential: Expansion into chemotherapy-induced bone marrow suppression could unlock a multi-billion-dollar market.
• Strategic Execution: Collaboration with a leading CRO ensures focused execution and timeline adherence.

About Regen BioPharma, Inc.

Regen BioPharma, Inc. is a publicly traded biotechnology company (PINK: RGBP) and (PINK: RGBPP). The Company is focused on the immunology and immunotherapy space. The Company is focused on rapidly advancing novel technologies through pre-clinical and Phase I/ II clinical trials. Currently, the Company is focused on mRNA and small molecule therapies for treating cancer and autoimmune disorders. Additional information on Regen BioPharma is available at http://www.regenbiopharmainc.com.

Disclaimer: This news announcement may contain forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. The risks and uncertainties to which forward looking statements are subject include, but are not limited to, the effect of government regulation, competition and other material risks.

CONTACT INFORMATION:

Regen BioPharma Inc.
David R. Koos, Ph.D.
Chairman & Chief Executive Officer
+1-619-722-5505 Phone
+1-619-330-2328 Fax
Email: david.koos@regenbiopharmainc.com or
david.koos@regenbiopharma.com
X (formerly twitter): https://x.com/TheRegenBio

FAQ

What is the expected timeline for RGBP's HemaXellerate Phase 1 clinical trial?

The Phase 1 clinical trial is expected to complete within 12 to 14 months once initiated.

What conditions will RGBP's HemaXellerate therapy target?

HemaXellerate will initially target aplastic anemia, with potential expansion into treating chemotherapy-induced bone marrow suppression.

What is the market size for RGBP's target indication in bone marrow suppression?

The chemotherapy-induced bone marrow suppression market is valued at over $1 billion annually.

Has RGBP received FDA clearance for HemaXellerate?

Yes, Regen BioPharma has received FDA clearance to begin clinical trials for HemaXellerate.