BioRestorative (NASDAQ: BRTX) Ramps Up Production In Anticipation Of Positive Phase 2 Results

Chronic lumbar disc disease (cLDD) is a debilitating condition affecting millions of people worldwide. It is characterized by back pain, stiffness, and restricted movement due to damage to the bony discs in the lower back. While its exact cause is unknown, factors such as age, obesity, poor posture, and overuse of the lumbar spine are believed to be contributing factors.

The burden of chronic lumbar disc disease is significant, with the World Health Organization estimating that up to 75% of adults will experience some form of chronic back pain throughout their lifetime. It is also estimated that 10-15% of those affected will have a long-term disability due to their condition.

To address the unmet need for an effective and safe way of treating this burdensome condition, BioRestorative Therapies BRTX launched a Phase 2 double-blind, controlled, randomized study of BRTX-100 in 99 American patients. BRTX-100 is an innovative technology that uses the patient’s cells to repair damage to discs in the back.

Phasing Into Bigger Future Production?

The phase 2 study is evaluating the initial efficacy and safety of a single dose of BRTX-100 compared to saline injected into the affected disk in the spine. Although the primary endpoints will be unblinded after all 99 patients have been treated, a critical milestone for BRTX is scheduled in March or April 2023 related to the safety profile of the product. 

An independent group of experts will assess the safety data of the first four patients treated in the study. This board of experts decides if a study can continue, if there needs to be changes in the way the study is conducted or if the study should be stopped entirely. BRTX is confident that the data from the study will show that BRTX-100 is safe in treating cLLD.

The outcome of the board examination will have a critical impact on its next moves — “Our advances in stem cell biology and delivery protocols harbor great promise in conditioning our bodies’ own regenerative potential to treat major diseases more effectively than current interventions.”

In anticipation of positive findings from this study, BRTX is increasing its manufacturing and quality control capacity and hiring new scientists to meet the demands for the BRTX-100 Phase 2 enrollment. The additional demand is expected not only for the phase 2 study in cLLD but for studies in other conditions affecting the neck, knee and hip. Clearing the safety hurdle of the trial enables the Company to expand its BRTX-100 platform into other indications more easily and at a greater pace.

Other companies in the stem cell therapy sector of the biotech industry include Sanofi SNY, Vertex Pharmaceuticals VRTX and BioMarin Pharmaceutical BMRN. 

Visit biorestorative.com for more information on the company and its product candidates.

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