AmMax Bio Announces Positive Interim Phase 2 Results of AMB-05X for the Treatment of Tenosynovial Giant Cell Tumor (TGCT)
Intra-articular (IA) Delivery of AMB-05X Demonstrates Proof-of-Concept in TGCT With A Rapid Onset of Tumor Reduction in All Patients Within Six Weeks
Interim AMB-05X Data Support Potential for Best-in-Class Therapy for Treatment of TGCT
Excerpt from the Press Release:
REDWOOD CITY, Calif., Oct. 20, 2021 (GLOBE NEWSWIRE) — AmMax Bio, Inc. (“AmMax”), a private clinical-stage biotech company developing novel treatments with AMB-05X, its proprietary anti-CSF1R monoclonal antibody platform, today announced positive interim data from a Phase 2 study of AMB-05X for the treatment of tenosynovial giant cell tumor (TGCT).
“We are very excited to report these positive interim results of AMB-05X for the treatment of TGCT”, said Larry Hsu, Ph.D., Chief Executive Officer of AmMax Bio. “We have sought to match our highly potent and selective monoclonal antibody with an optimal local delivery route for superior efficacy and safety, that delivers best-in-class clinical benefits for patients suffering from TGCT. What we have seen so far supports that AMB-05X could dramatically impact the current treatment paradigm, with an unparalleled fast onset of response after only 6 weeks and no significant adverse events. We are working closely with our investigators in Europe and the U.S. to complete our Phase 2 program and prepare for a pivotal trial.”
The Phase 2 trial is designed as a 12-week adaptive, multi-center, open-label, proof-of-concept study to evaluate the safety, efficacy and pharmacokinetics of intra-articular injections of AMB-05X in patients with TGCT of the knee – the predominant joint affected by this sarcoma. (ClinicalTrials.gov Identifier: NCT04731675). Key study outcomes include overall response rate (ORR) via magnetic resonance imaging (MRI), improvements in pain, stiffness, range-of-motion, quality-of-life, pharmacokinetics measures and safety.
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