Panbela Therapeutics Regains Worldwide Rights to Develop and Commercialize Rare Cancer Treatment

Clinical stage biopharmaceutical company, Panbela Therapeutics (Nasdaq: PBLA), has regained the worldwide rights to develop and commercialize Flynpovi as a potential treatment for familial adenomatous polyposis (FAP), a rare, inherited cancer.

Panbela is now positioned to take the lead on its global clinical trial protocol and present it to the Federal Drug Administration (FDA) and European Medicines Agency (EMA) for feedback on the registration pathway.

Highlights

Panbela’s new registration trial will build upon the positive results from the company’s FAP-310 trial that were published in the New England Journal of Medicine and Disease of the Colon and Rectum (Burke et al. 2020; Balaguer et al. 2022).

The company believes the new registration trial will have the potential to provide a non-surgical treatment option to both physicians and patients.

Flynpovi is a combination of CPP-1X (eflornithine) and sulindac. In a Phase 3 clinical trial in patients with sporadic large bowel polyps, Flynpovi prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo.

There are currently no approved drug therapies for the treatment of FAP. Panbela believes its therapeutic option has the potential to impact this urgent unmet need globally.

The announcement is the result of the termination of the licensing agreement between Cancer Prevention Pharmaceuticals, Inc. (CPP) and with One-Two Therapeutics Assets Limited.

About Panbela Therapeutics

Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for patients with urgent unmet medical needs. Panbela’s lead assets are Ivospemin (SBP-101) and Flynpovi.

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Panbela Therapeutics Regains Worldwide Rights to Develop and Commercialize Rare Cancer Treatment

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