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By Faith Ashmore, Benzinga
BioRestorativeTherapies Inc. (NASDAQ: BRTX) (“BioRestorative”) may have hada successful year of novel drug development. The company is engaged indeveloping therapeutic products using cell and tissue protocols,primarily with adult stem cells, for large multi-billion dollarmarkets that are underserved and affect millions of Americans, likechronic lower back pain and metabolic disorders.
BioRestorativecurrently has two major programs that are being evaluated fora variety of chronic diseases and pain. Their novel drug BRTX-100 isan autologous stem cell product; the cells are harvested, cultured andthen injected directly into the patient’s body. BioRestorative’sother product — ThermoStem® — has shown promising results inpreclinical models for the treatment of obesity and related metabolicdiseases.
InDecember, BioRestorative was awarded a Small Business InnovationResearch (SBIR) grant. This grantwas given for the development and evaluation of the company’sThermoStem program for developing a therapeutic to treatpolycystic ovary syndrome (PCOS). Previously, the company was granteda Small Business Technology Transfer (STTR) grant for Phase 1development of BRTX-100 to explore the therapeutic effects ofPEG-peptide hydrogel-encapsulated hypoxic bone marrow stem cells.It’s rare that a company of its size has received two governmentgrants, validating its technology and potential application.
The company entered intoan agreement with Regenexx, LLC, providing BioRestorative with theexclusive worldwide commercial rights of the intellectual propertythat is underlying some key principles of BRTX-100. Currently,BRTX-100 is in a Phase 2 trial with approximately 15 sites in the U.S.This exclusive arrangement should provide value to BRTX and or acommercial partner in potential later-stage development transactions.
BRTX-100 beganPhase 2 trials in February, defined as a prospective, randomized,double-blinded controlled study to evaluate the efficacy and safety ofBRTX from a single injected dose.
One of the company’s significant developments in2022 was the completion of a cGMP manufacturing facility with an ISO7-certified clean room. This facility was completed in April and wasinstrumental in progressing the company forward to meet the needs ofPhase 2 clinical trials for chronic lumbar disc disease.
Throughout the year,BioRestorative participated in several high-profile conferences. Thecompany presented at H.C. Wainwright Bioconnect, Roth InauguralHealthcare Conference and Dawson James Securities Conference, to namea few.
BioRestorative was also granted a patent application for theirThermoStem program in Japan, which demonstrates the company’spotential for global application of their therapeutic products.
BioRestorative and othercompanies like Lineage Cell Therapeutics Inc (NYSE: LCTX), BrainstormCell Therapeutics Inc (NASDAQ: BCLI), Vericel Corp (NASDAQ: VCEL) andlarge cap pharma as well such as Novo Nordisk (NYSE: NVO) and PfizerInc. (NYSE: PFE) are leading the charge towards a new era of medicaladvancement. As biotech companies become increasingly successful atproviding therapeutic solutions, it will be interesting to see howtechnology and innovation leads to higher quality of life for patientswho have previously been left with little or no solutions.
To learn more aboutBioRestorative, visit its website .
This article wasoriginally published on Benzinga here .
BioRestorativeTherapies was founded by scientists and researchers committed todeveloping stem cell therapies to address unmet needs in patients withhighly prevalent conditions.Our advances in stem cell biology anddelivery protocols harbor great promise in conditioning our bodies’own regenerative potential to treat major diseases more effectivelythan current interventions.Today, BioRestorative is activelydeveloping programs that aim to dramatically increase quality of carefor both (i) chronic back pain caused by disc degeneration, as well as(ii) metabolic disorders including obesity anddiabetes.
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