- Theradaptive expands dosing of patients in Phase I/II OASIS trial to include clinical sites in Maryland
- MSCRF awards Theradaptive $1 million to support manufacturing of OsteoAdapt™ SP and other regenerative therapeutics
FREDERICK, Md., Jan. 30, 2025 /PRNewswire-PRWeb/ -- Theradaptive, a Maryland-based, privately held, clinical-stage biologics company, today announced the initiation of patient dosing in Maryland for the ongoing OASIS Phase I/II clinical trial assessing OsteoAdapt™ SP, the company's lead product for spinal fusion.
Two patients were treated at MedStar Health in Maryland by Dr. David A. Weiner in January 2025, marking the first clinical cases in Maryland. This procedure is part of the company's OASIS Phase I/II clinical trial, currently enrolling to measure the safety and efficacy of OsteoAdapt SP for the treatment of degenerative diseases of the lumbosacral spine. OsteoAdapt SP is designed with the goal of offering a promising alternative to current therapies while minimizing off-target effects, addressing both the efficacy and safety concerns related to existing standards of care. Theradaptive does this by utilizing a modified variant of recombinant human bone morphogenetic protein-2 (BMP-2), called AMP2, to stimulate the body's stem cells for targeted bone regeneration. This method ensures targeted delivery of therapeutic benefits.
"Theradaptive's technology represents a major advancement in regenerative medicine, and I am honored to contribute to this important clinical study to assess its potential in improving spinal fusion outcomes for patients both locally and globally." said Dr. David A. Weiner, Spine Surgeon at Medstar Health.
Driving Growth and Innovation in Maryland
This milestone is part of Theradaptive's broader commitment to advancing medical innovation, a goal supported by a recent $1,000,000 grant from the Maryland Stem Cell Research Commission (MSCRC) through the Maryland Stem Cell Research Fund (MSCRF) Manufacturing Assistance Program. This marks the second manufacturing award from MSCRF. Theradaptive received the first MAP award in 2023. Over the past five years, MSCRF has provided Theradaptive with various levels of financial support through its funding programs, including two Commercialization Grants. MSCRF is dedicated to fostering advancements in medical research using human stem cells, aiming to develop new strategies for disease prevention, diagnosis, treatment, and cure. The latest MAP grant will play a crucial role in accelerating the OASIS clinical trial and enhancing Theradaptive's manufacturing capabilities.
As part of its growth strategy, Theradaptive is expanding its Maryland headquarters to include a state-of-the-art GMP manufacturing facility. This new facility will support ongoing clinical trials and future commercial production, and create new jobs in research, development, quality, and manufacturing. The expansion underscores the company's commitment to contributing to Maryland's vibrant life sciences ecosystem.
"The successful dosing of our first patient in Maryland marks a significant moment in the OASIS trial, affirming the potential of OsteoAdapt SP to redefine spinal repair," stated Dr. Luis Alvarez, CEO and Founder of Theradaptive. "This milestone not only highlights the therapeutic promise of our technology but also emphasizes Theradaptive's continued commitment to Maryland's biotechnology ecosystem. The manufacturing grant from the MSCRF is pivotal, enabling us to scale up manufacturing and streamline the delivery of this cutting-edge therapy to patients, accelerating our mission to enhance patient outcomes."
Ruchika Nijhara, Executive Director of the Maryland Stem Cell Research Fund (MSCRF), a state supported funding program, stated, "Our mission is to accelerate the development of new medical strategies for the treatment of human diseases, injuries and conditions by providing funding that ensures these advancements reach patients as quickly as possible. MSCRF funding to support Theradaptive's clinical and manufacturing activities in Maryland reflects MSCRF's commitment to nurturing the growth of Maryland cell-based therapy companies and facilitating the establishment of biotechnology capabilities within the state. We are excited about Theradaptive's clinical progress and eagerly anticipate the benefits that OsteoAdapt SP treatment will bring to patients in Maryland and beyond."
About Theradaptive
Theradaptive is a privately held, clinical-stage biologics company developing protein therapeutics for spine, orthopedics, soft tissue repair and targeted immuno-oncology. Based in Frederick, Maryland, the Company is leveraging its therapeutic delivery platform to deliver recombinant biologics to targeted areas in the body with high precision and persistence to address unmet medical needs. For more information on Theradaptive and its clinical development program, visit http://www.theradaptive.com and follow the company on LinkedIn.
OsteoAdapt™ SP is an Investigational Device. Limited by US Federal law to investigational use.
In addition to MSCRF support, this work was supported by the Assistant Secretary of Defense for Health Affairs in the Department of Defense, through the Peer Reviewed Medical Research Program under Award No. HT9425-23-1-0693. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of Defense.
Media Contact
Serena Santiago, Theradaptive, (617) 454-4050, [email protected], www.theradaptive.com
Jim O'Brien, Theradaptive, (512)699-5281, [email protected], www.theradaptive.com
SOURCE Theradaptive
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