Here’s what we’ve been working on, "Cutting Edge Science".
Olaregen Therapeutix Inc. Pipeline
Our pipeline focus is in the area regenerative medicine. Regenerative medicine is a branch of translational research in tissue engineering and molecular biology which deals with the “process of replacing, engineering or regenerating human cells, tissues or organs to restore or establish normal function”.
The promising field of Regenerative Medicine is working to restore structure and function of damaged tissues and organs. The goal of our research is to find a way to cure previously untreatable injuries and diseases. The goal of our research is working to make treatments available for clinical use for patient in need of life saving medications.
Our Recent Work
FIND A NEW WOUND CARE PATHWAY
Excellagen® used in Stem Cells human clinical study
Published February 21, 2019
In addition, to Excellagen®’s FDA-cleared uses for the treatment of chronic non-healing dermal wounds, its pharmaceutically formulated flowable dermal matrix has been engineered as a platform technology, enabling multiple therapeutic product extensions for tissue regeneration based on stem cells, biologics, peptides and small molecule drugs.
Excellagen®’s pharmaceutically formulated, aseptically-manufactured, three-dimensional fibrillar collagen, has been engineered to serve as a cell and biologics delivery platform, enabling multiple device, tissue scaffolding and therapeutic product extensions for tissue regeneration based on stem cells, biologics, peptides and small molecule drugs.
As a delivery platform, the use of allogeneic mesenchymal stem cells offers the opportunity to further potentiate Excellagen®’s already established biological capacity to stimulate rapid regeneration of granulation tissue.
Boston Children’s Hospital to Evaluate Excellagen®’s Potential Role in Repairing Birth Defects
In addition to the REDDSTAR initiative, Excellagen® was used with researchers at Boston Children’s Hospital, to assess the medical utility of Excellagen® as a delivery scaffold to seed autologous mesenchymal fetal stem cells for ex-vivo engineering of tissue grafts for transplantation into infants to repair prenatally diagnosed birth defects.
Autologous mesenchymal fetal stem cells are derived prenatally from infants with a medical defect requiring life-saving tissue repairs. These stem cells are sourced from amniotic fluid, the placenta or umbilical cord blood. The stem cells are then seeded into a scaffold to promote the growth of an engineered tissue graft.
These grafts will potentially be used to surgically repair, either in the fetus or immediately following birth, certain prenatally diagnosed birth defects that could include congenital diaphragmatic hernia, tracheal and chest wall defects, bladder extrophy and various cardiac anomalies.
Excellagen® is an FDA-approved homogenate that represents a new product delivery platform for the potential development of a portfolio of advanced tissue regeneration therapeutic opportunities. These opportunities could include anti-infectives, antibiotics, peptides, proteins, small molecules, DNA, stem cells, differentiated cells, and conditioned cell media.
RNS & INVESTOR NEWS - Jan 15th, 2019
New Manufacturing Agreement for Excellagen® Collagen Wound Healing Matrix
Collagen Solutions plc (AIM: COS), the developer and manufacturer of biomaterials and regenerative medicines for the enhancement and extension of human life, announces that it has entered into a new agreement with Olaregen Therapeutix, Inc. (“Olaregen”) to manufacture and produce Excellagen®, an advanced FDA 510(k)-cleared wound healing product indicated for the treatment of hard to heal wounds such as diabetic foot ulcers.
The Company originally assisted in the development of and manufactured Excellagen® for Gene Biotherapeutics Inc. (formerly Taxus Cardium Pharmaceuticals Group Inc.) prior to 2014, who had been seeking a strategic partner for the launch of Excellagen®. Gene Biotherapeutics announced a transaction with Olaregen in September 2018 covering the sale of Excellagen® for wound healing. With these new agreements, Collagen Solutions is now supporting Olaregen’s launch of Excellagen® in the first half of 2019.
Wound care products are designed to cure and treat a variety of complex wounds, both chronic and acute. Examples are diabetic foot ulcers, venous and pressure ulcers, burns, trauma and others for which Excellagen® is cleared for use. The rising incidence of difficult to treat wounds, resulting from increasing prevalence of diabetes and a rapidly aging population, is driving growth in the wound care space and encouraging developments and innovations in enhanced wound care products, such as Excellagen®.
Commenting on the win, Jamal Rushdy, CEO says: “We are delighted to sign this contract with Olaregen and are excited to be part of the Excellagen® launch. This new agreement is consistent with our strategy to move up the value chain by collaborating with industry partners to develop and launch innovative products designed to improve patients’ lives.”
“Olaregen is pleased to partner with the world class manufacturer, Collagen Solutions, to manufacture Excellagen®, our initial product offering. We have the utmost confidence in Collagen Solutions to provide us with a high-quality product that meets mandated standards. This may be our most important partnership.” said Anthony J. Dolisi, CEO of Olaregen