CANTEX PHARMACEUTICALS RECEIVES FDA ORPHAN DRUG DESIGNATION FOR AZELIRAGON FOR THE TREATMENT OF BRAIN METASTASIS FROM BREAST CANCER
Rhea-AI Summary
Cantex Pharmaceuticals has received FDA Orphan Drug Designation for azeliragon to treat brain metastasis from breast cancer. This is the third such designation for azeliragon, following previous designations for pancreatic cancer and glioblastoma in mid-2024 and early 2023.
Azeliragon is an oral, once-daily compound that inhibits the RAGE receptor. The drug's interaction with RAGE on cancer cells has been linked to radiation resistance, disease progression, and metastasis development in breast cancer. This designation provides Cantex with seven years of marketing exclusivity upon product launch, along with development assistance, tax credits, and FDA fee exemptions.
Positive
- Received FDA Orphan Drug Designation for brain metastasis treatment
- Third Orphan Drug Designation for azeliragon, showing expanded therapeutic potential
- Seven years of marketing exclusivity upon product launch
- Additional benefits including tax credits and FDA fee exemptions
Negative
- None.
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Cantex's azeliragon is a well-tolerated compound, administered orally once-a-day, that inhibits the receptor for advanced glycation end products (known as RAGE). The binding of RAGE on cancer cells to S100 proteins and other ligands has been linked to resistance to radiation, disease progression, and development of metastasis in breast cancer.
The development of brain metastasis is a life-threatening complication of breast cancer. Although critically important life-extending advances in the treatment of brain metastasis from some forms of breast cancer have recently been made, brain metastasis from triple-negative breast cancer, an aggressive subtype of breast cancer, remains a therapeutic challenge greatly in need of improved treatments.
"Receiving FDA Orphan Drug Designation for azeliragon for the treatment of brain metastasis from breast cancer highlights a continued need for new treatment options for these patients," commented Stephen G. Marcus, M.D., Chief Executive Officer of Cantex. "This designation reflects our continued commitment to developing new azeliragon treatment options for patients with life-threatening cancer."
In addition to azeliragon's already issued composition of matter and other patents, FDA Orphan Drug Designations provide Cantex with seven years of azeliragon marketing exclusivity from the time of product launch for the orphan indication, and several other important benefits, including assistance in the drug development process, tax credits for clinical costs, and exemptions from certain FDA fees.
About Azeliragon
Azeliragon is an orally administered capsule, 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 tumor microenvironment. Azeliragon was discovered by and originally under development for Alzheimer's disease by vTv Therapeutics Inc. (NASDAQ: VTVT) from which Cantex licensed worldwide rights to azeliragon. Clinical safety data from those trials, involving more than 2000 individuals dosed for periods up to 18 months, indicate that azeliragon is very well tolerated.
Cantex has ongoing clinical trials in brain metastasis, glioblastoma, breast cancer, pancreatic cancer, and hospitalized patients with pneumonia. These trials are based on azeliragon's robust preclinical data as well as its extensive clinical safety information from randomized placebo-controlled clinical trials.
About Cantex Pharmaceuticals, Inc.
Cantex Pharmaceuticals, Inc. 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.
About vTv Therapeutics Inc.
vTv Therapeutics Inc. is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv's clinical pipeline is led by cadisegliatin, a potential adjunctive therapy to insulin for the treatment of type 1 diabetes patients. vTv and its development partners are investigating additional indications including type 2 diabetes and other chronic conditions. To learn more please visit vtvtherapeutics.com.
Contacts:
Cantex Pharmaceuticals, Inc.
Stephen G. Marcus, M.D.
+1 954-315-3660
info@cantex.com
Juan F. Rodriguez
+1 954-315-3660
info@cantex.com
Tiberend Strategic Advisors, Inc.
Investors
Jon Nugent
+1 646-577-8520
jnugent@tiberend.com
Media
Casey McDonald
+1 646-577-8520
cmcdonald@tiberend.com
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SOURCE Cantex Pharmaceuticals, Inc.