CANTEX PHARMACEUTICALS RECEIVES FDA ORPHAN DRUG DESIGNATION FOR AZELIRAGON FOR THE TREATMENT OF PANCREATIC CANCER
Cantex Pharmaceuticals announced that the FDA has granted Orphan Drug Designation to its drug azeliragon for treating pancreatic cancer. This designation follows a similar status received for treating glioblastoma in 2023. The designation offers benefits like seven years of marketing exclusivity, tax credits, and fee exemptions. Cantex is conducting a clinical trial to study azeliragon's efficacy on metastatic pancreatic cancer patients in top U.S. cancer centers. CEO Stephen G. Marcus emphasized the urgent need for new treatments for advanced pancreatic cancer and other cancers, enhancing their commitment to innovative therapies.
- FDA Orphan Drug Designation for azeliragon provides seven years of market exclusivity.
- Orphan Drug Designation comes with benefits such as tax credits and fee exemptions.
- Azeliragon is well-tolerated and administered as a once-a-day pill.
- Ongoing clinical trials for azeliragon in metastatic pancreatic cancer are enrolling patients at top U.S. cancer centers.
- Clinical efficacy of azeliragon is still under investigation and not yet proven.
- Potential delays in clinical trial results can impact investor confidence.
- Dependence on FDA assistance and benefits for drug development indicates potential financial risks.
Insights
The FDA's Orphan Drug Designation for Cantex Pharmaceuticals' azeliragon in the treatment of pancreatic cancer is a significant development in the medical research field. This designation is particularly important for pancreatic cancer patients, as the disease is known for its high mortality rate and limited treatment options. The exclusivity period and other benefits provided by the orphan drug status will likely encourage further investment in the development and clinical trials of azeliragon. Additionally, the ongoing clinical trial for patients refractory to first-line treatment indicates a focus on addressing unmet medical needs. This development exemplifies the FDA's intention to support innovative therapies for rare and deadly diseases.
From a financial perspective, the FDA's Orphan Drug Designation offers substantial economic benefits to Cantex Pharmaceuticals. The seven-year marketing exclusivity positions the company to potentially dominate a specific niche market without immediate competition. This exclusivity is important for recouping the significant R&D costs associated with developing new cancer therapies. Moreover, tax credits for clinical costs and exemptions from FDA fees will reduce the financial burden on the company, allowing more resources to be directed towards further development and possibly other therapeutic areas. Investors might see this as a positive signal, potentially leading to an uptick in stock value as the company progresses with its clinical trials and moves closer to commercialization.
The designation of azeliragon as an orphan drug for pancreatic cancer is noteworthy from a clinical standpoint. Pancreatic cancer is notoriously difficult to treat and new therapeutic options are desperately needed. The fact that azeliragon is already being tested in patients who have not responded to first-line treatments suggests it might offer a new hope for those with advanced disease. Additionally, the ongoing trials at reputable cancer centers provide a robust framework for assessing the drug's efficacy and safety. If successful, this could lead to a shift in the treatment paradigm for pancreatic cancer, offering a new line of defense where current options fall short.
Pancreatic cancer, unless controlled at its earliest stages, often spreads to local tissues and to distant organs. Although surgery can be curative if pancreatic cancer is diagnosed at its very earliest stages, once the cancer has spread to distant organs, the current treatment has some, although limited, efficacy. New treatments are clearly needed.
Cantex has an ongoing clinical trial studying the safety and efficacy of azeliragon in patients refractory to first-line treatment of metastatic pancreatic cancer. This clinical trial is enrolling metastatic pancreatic cancer patients in several world-class cancer treatment centers in the
"Receiving FDA orphan drug status for azeliragon for the treatment of pancreatic cancer underscores the significant unmet need for novel treatment options for patients with pancreatic cancer, particularly for those patients with locally advanced, unresectable, or metastatic disease," commented Stephen G. Marcus, M.D., Chief Executive Officer of Cantex. "This designation strengthens our continued commitment to developing new azeliragon treatment options for patients with pancreatic cancer, as well as for other cancers and their complications, including glioblastoma, brain metastasis and breast cancer."
FDA Orphan Drug Designation provides 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 these trials, involving more than 2000 individuals dosed for periods up to 18 months, indicate that azeliragon is very well tolerated.
Cantex has ongoing Phase 2 clinical trials in pancreatic cancer, glioblastoma, brain metastasis, breast cancer, and a Phase 3 trial in 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 clinical stage biopharmaceutical company focused on developing oral, small molecule drug candidates, led by cadisegliatin (TTP399), a potentially transformative treatment for the reduction of hypoglycemic episodes in type 1 diabetes patients. To learn more please visit vtvtherapeutics.com.
Contact Data:
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
Daniel Kontoh-Boateng
+1 862-213-1398
dboateng@tiberend.com
Media
Casey McDonald
+1 646-577-8520
cmcdonald@tiberend.com
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SOURCE Cantex Pharmaceuticals, Inc.
FAQ
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