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No-Option Refractory Disabling Angina (NORDA) – CLBS14 (OLOGO™ in the U.S.)

What is No-Option Refractory Disabling Angina (NORDA)?

No-option refractory disabling angina (NORDA) describes patients who have severe and disabling angina, which persists despite revascularization (e.g. bypass surgery or stenting) and optimal medical therapy.

Refractory angina (RA) describes the small proportion of patients with angina who have symptoms despite revascularization and optimal medical therapy (Henry et al. 2014). RA patients are also frequently referred to as ‘No-Option’ Refractory Angina (NORA) to emphasize that revascularization options have been exhausted (Mannheimer et al. 2002, Jolicoeur et al. 2008a, Jolicoeur et al. 2008b, Jolicoeur et al. 2012). These patients typically have had repeated prior angioplasty and stenting or open-heart bypass surgery, or they can have unsuitable coronary anatomy with severe diffuse atherosclerosis or have other advanced comorbidities.  A subset of NORA patients have severely symptomatic, or disabling angina, and are described as No-Option Refractory Disabling Angina (Benck and Henry 2019).

Market Opportunity for NORDA

In the United States, we have identified fewer than 100,000 patients with NORDA as candidates for OLOGO™ (CLBS14), making this an orphan-size indication.

Our Approach: CLBS14 (OLOGO™ in the U.S.)

We acquired the rights to data and regulatory filings for this CD34+ cell therapy program for NORDA that had been advanced to Phase 3 by a previous sponsor. Based on the clinical evidence from the completed studies, a single administration of OLOGO™ reduces mortality, improves angina, and increases exercise capacity in patients with otherwise untreatable angina. This product has received a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. We remain in discussion with the FDA regarding a Phase 3 trial of appropriate and practical size which, in combination with existing Phase 1, 2 and 3 data, will be considered for the registration of OLOGO™. Notably, the RMAT designation affords the product a more rapid 6-month review time for a biologics license application (BLA), once submitted.

References

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