Cantex Receives FDA "Study May Proceed" Letter for Phase 2 Clinical Trial of Azeliragon for the Treatment of Unmethylated Glioblastoma

Rhea-AI Summary

Cantex Pharmaceuticals has announced FDA approval to proceed with a Phase 2 clinical trial for azeliragon, targeting newly diagnosed unmethylated glioblastoma patients. This oral medication, taken once daily, has also received Orphan Drug Designation. Glioblastoma, the most common primary brain cancer, presents a serious prognosis, with a median survival of only 15-18 months. Azeliragon aims to inhibit critical interactions in the glioblastoma microenvironment, offering hope for improved outcomes. Additionally, Cantex is exploring azeliragon’s application in other cancers, highlighting its potential versatility. Significant advancements are expected in clinical trials during 2023 and 2024.

Positive

• FDA 'Study May Proceed' letter enables Phase 2 trial initiation for azeliragon.
• Azeliragon granted Orphan Drug Designation for glioblastoma.
• Potential for azeliragon to treat multiple cancers, enhancing market opportunity.

Negative

• Previous trials for azeliragon in Alzheimer's did not demonstrate efficacy.

Cantex is developing azeliragon as a once-a-day pill for the treatment of glioblastoma and other cancers

WESTON, Fla., Feb. 27, 2023 /PRNewswire/ -- Cantex Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions, announced today that the U.S. Food and Drug Administration (FDA) reviewed Cantex's Investigational New Drug application and issued a "Study May Proceed" letter for Cantex's Phase 2 clinical trial to assess the safety and therapeutic effect of azeliragon in patients with newly diagnosed unmethylated glioblastoma treated with standard of care radiation therapy. Azeliragon was recently granted FDA Orphan Drug Designation for the treatment of glioblastoma.

"We are very pleased to have received this favorable response from the FDA enabling Cantex to initiate a Phase 2 clinical trial of azeliragon for the treatment of glioblastoma," commented Stephen G. Marcus, M.D., Chief Executive Officer of Cantex. "Today's news significantly advances Cantex's azeliragon development program. We look forward to soon commencing enrollment in this trial given the urgent need for novel therapies that can better address this devastating disease."

Glioblastoma is the most common primary brain cancer, with approximately 13,000 cases diagnosed in the U.S. per year. It is a highly malignant brain tumor for which current therapeutic options provide a limited life extension benefit. The median survival after a glioblastoma diagnosis is 15-18 months and 5-year survival is less than 10%. Given this prognosis, new treatments of glioblastoma are urgently needed.  

Azeliragon is an orally administered small molecule, taken once daily, that inhibits interactions of the receptor for advanced glycation end products (known as RAGE) with certain ligands, including HMGB1 and S100 proteins in the glioblastoma microenvironment. By preventing interaction of RAGE with these ligands, azeliragon may inhibit glioblastoma and overcome its resistance to effective treatment. Cantex is also developing azeliragon for the treatment of other major cancers not adequately addressed by current treatments where RAGE has been implicated in disease progression and in complications of cancer treatment.

Dr. Marcus continued: "The Phase 2 trial of azeliragon in glioblastoma is one of several promising clinical programs we continue to advance with azeliragon to treat cancer and other diseases where RAGE is implicated. Additional azeliragon indications include pancreatic cancer, breast cancer, and cancers such as lung cancer and breast cancer that have metastasized to the brain. These programs highlight the versatility of azeliragon and our commitment to develop new treatment options for these cancers. We expect significant progress on these clinical trials during 2023 and 2024."

About Azeliragon
Azeliragon, previously known as TTP488, is an orally active, small molecule, antagonist of the receptor for advanced glycation end products (RAGE) licensed by Cantex from vTv Therapeutics Inc. (NASDAQ:VTVT). vTv Therapeutics discovered azeliragon and carried out phase 3 clinical trials for Alzheimer's disease. Although these trials did not demonstrate efficacy in Alzheimer's disease, clinical safety data from these trials, involving over 2000 patients dosed for periods up to 18 months, indicate that azeliragon is very well tolerated. A broad range of evidence suggests that RAGE—ligand interactions play a critical role in cancer and its complications as well as in a range of inflammatory diseases.

About Cantex Pharmaceuticals, Inc. 
Cantex Pharmaceuticals is a privately held, clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions for which new treatments are urgently needed. For more information, please visit www.cantex.com.

Contacts:

Tiberend Strategic Advisors, Inc.
Investors
Jon Nugent
+1 205-566-3026
jnugent@tiberend.com

Media
Casey McDonald
+1 646-577-8520
cmcdonald@tiberend.com 

Cantex Pharmaceuticals, Inc.:
Stephen G. Marcus, M.D.
+1 954-315-3660
smarcus@cantex.com

View original content:https://www.prnewswire.com/news-releases/cantex-receives-fda-study-may-proceed-letter-for-phase-2-clinical-trial-of-azeliragon-for-the-treatment-of-unmethylated-glioblastoma-301756067.html

SOURCE Cantex Pharmaceuticals, Inc.

FAQ

What is the purpose of Cantex's Phase 2 trial for azeliragon?

The trial aims to evaluate the safety and therapeutic effect of azeliragon in patients with newly diagnosed unmethylated glioblastoma.

What recent FDA action was taken regarding azeliragon?

The FDA issued a 'Study May Proceed' letter, allowing Cantex to initiate its Phase 2 clinical trial for azeliragon.

What is the prognosis for glioblastoma patients?

Glioblastoma has a median survival of 15-18 months and less than 10% survive five years post-diagnosis.

What is azeliragon and how does it work?

Azeliragon is an orally administered small molecule that inhibits interactions of the RAGE receptor, potentially impacting glioblastoma progression.

Which other cancers is azeliragon being developed to treat?

Cantex is exploring azeliragon for pancreatic cancer, breast cancer, and cancers that have metastasized to the brain.