SignPath Pharma Announces Orphan Drug Designation and Fast Track Submission for LipoCurc™ in Glioblastoma

SignPath Pharma advances LipoCurc™ GBM program with FDA Orphan Drug Designation and submission of Fast Track and CNPV requests

SANDY, UT, UNITED STATES, December 16, 2025 /EINPresswire.com/ -- SignPath Pharma, Inc., a clinical-stage biotechnology company developing LipoCurc™, a novel liposomal formulation of curcumin, today announced multiple significant regulatory achievements for its liposomal curcumin (LipoCurc™) clinical program in glioblastoma (GBM), an aggressive and devastating brain cancer with limited treatment options.

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to LipoCurc™ for the treatment of malignant glioma. In addition, SignPath has recently submitted a Fast Track Designation request to the FDA this week and separately submitted a justification package for consideration under the FDA’s National Priority (CNPV) Voucher Program.

These regulatory submissions reflect the encouraging safety profile and preliminary clinical activity observed to date in SignPath’s ongoing Phase I/II study of LipoCurc™ in combination with standard-of-care radiation therapy and temozolomide in newly diagnosed glioblastoma.

Orphan Drug Designation
Orphan Drug Designation provides SignPath with multiple program advantages, including regulatory guidance, reduced fees, tax credits, and up to seven years of market exclusivity upon approval.

Fast Track Designation Submission
SignPath has submitted a Fast Track designation request to the FDA. Fast Track designation is intended to accelerate development and expedite regulatory review of therapies with the potential to address serious conditions and unmet medical needs.

“Based on our preliminary data, we believe that LipoCurc™ has the potential to help patients who are fighting glioblastoma, and this drug warrants expedited development,” said Kai Larson, Chief Executive Officer of SignPath Pharma. “Submitting our Fast Track application marks an important step in bringing LipoCurc™ to patients who urgently need new treatment options.”

FDA National Priority (CNPV) Voucher Program Submission
In parallel, SignPath submitted a justification package for review under the FDA’s new National Priority Voucher (CNPV) Program, which rewards development of therapies targeting urgent public health challenges, including conditions with severe unmet need such as glioblastoma.

“This is a significant opportunity for the program,” said Michelle Comas, Chief Operating Officer of SignPath Pharma. “The combination of Orphan Drug Designation, Fast Track submission, and the CNPV application positions LipoCurc™ for a potentially accelerated regulatory path as we prepare to meet with the FDA in early 2026.”

About the LipoCurc™ GBM Program
LipoCurc™ is currently being evaluated in an ongoing Phase I/II open-label clinical trial conducted at Johns Hopkins Hospital and Sibley Memorial Hospital. The study evaluates LipoCurc™ in combination with standard-of-care radiation therapy and temozolomide in patients with newly diagnosed glioblastoma.
The dose-escalation portion (Part 1) of the study has been completed, establishing the recommended Phase 2 dose. The study is now in Part 2, with some patients actively receiving treatment and others in long-term follow-up. Emerging data continue to support a favorable safety profile and encouraging preliminary efficacy signals indicating benefits in survival and time to disease recurrence following surgery.

SignPath is preparing for a Phase II/III registrational development program, as well as beginning a trial using LipoCurc™ in multiple myeloma patients.

About SignPath Pharma, Inc.
SignPath Pharma is a clinical-stage biotechnology company focused on developing targeted therapeutics for serious and life-threatening diseases. The company’s lead investigational compound is a proprietary liposomal formulation of curcumin currently being evaluated for its potential in oncology and other therapeutic areas. SignPath is headquarters in Sandy, Utah. For more information, please visit www.signpathpharma.com.
Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the future development, potential benefits, and clinical evaluation of LipoCurc™. These statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual outcomes to differ materially from those anticipated. SignPath undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Contact:
Kai Larson
President, CEO
klarson@signpathpharma.com
https://signpathpharma.com

Michelle Comas
SignPath Pharma
mcomas@signpathpharma.com

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.