13 January 2021
- National Cancer Institute (NCI) study investigating zotiraciclib (ZTR) in combination with temozolomide (TMZ) demonstrates meaningful clinical efficacy
- ZTR has a favorable safety profile and was found to be well tolerated
- Based on positive top-line Phase 1b data, Adastra Pharmaceuticals, Inc. is steadfast in undertaking a registration-enabling clinical study in the first half of 2021
PRINCETON, N.J., Jan. 13, 2021 /PRNewswire/ -- Adastra Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of first-in-class therapeutics for the treatment of cancer, today announced the completion of the Phase 1b clinical trial conducted by the NCI with its lead clinical candidate zotiraciclib (ZTR/TG02), a potent oral cyclin-dependent kinase 9 (CDK9) inhibitor. The trial investigated the safety and efficacy of ZTR, in combination with temozolomide (TMZ), in patients with recurrent high-grade gliomas.
The Phase 1b trial exceeded or met the prespecified trial endpoint of progression-free survival (PFS) and provided a recommended dosing of ZTR. In the subset of patients who had isocitrate dehydrogenase (IDH) mutated tumors, the combined treatment with ZTR and temozolomide conferred a profound benefit of mPFS over historical control. The study additionally found ZTR to be well tolerated. The trial was sponsored and conducted by the NCI, and NCI expects to publish and report its findings and present them at an upcoming medical conference in 2021.
"Because preclinical data demonstrated the ability of ZTR to inhibit CDK9, enhance apoptosis and cause mitochondrial dysfunction and ultimately ATP depletion in glioma cells, we were optimistic about this first-in-human glioma trial," said Jing Wu, M.D., Ph.D., NCI's Principal Investigator of the 17-C-0009 trial. "The data from the Phase 1b trial support our initial expectations and reinforce our energies to continue to investigate ZTR as a treatment for patients with gliomas."
"We are very grateful to our NCI colleagues, the patients, and their families for their participation in this trial. Recurrent high-grade gliomas are aggressive malignant brain tumors and remain difficult cancers to treat. Currently, available agents used for the treatment of gliomas offer little or no proven benefit; new therapeutic options are needed," said Scott Megaffin, Chief Executive Officer of Adastra. "We are exceptionally encouraged by the potential of zotiraciclib as a new treatment alternative for patients with recurrent high-grade gliomas. On the basis of these findings, Adastra is in active preparation of a registration-enabling clinical study of ZTR in patients with recurrent high-grade gliomas, in addition to work now underway to expand the application of ZTR to additional solid tumors and hematologic malignancies."
The majority of glioblastoma multiforme (GBM) cases are recurrent, and the mortality rate for patients with recurrent gliomas is nearly 100%, representing a significant unmet medical need. Furthermore, currently approved treatment options for recurrent, high-grade gliomas have limited effectiveness, creating the need for medicines like ZTR, which possesses a unique mechanism of action. ZTR is a potent oral CDK9 inhibitor with the ability to readily cross the blood-brain barrier and deplete short-lived proteins like Mcl-1 and Myc, known antiapoptotic oncogenes.
About Adastra Pharmaceuticals
Adastra Pharmaceuticals Inc. is an innovative, private, clinical-stage biopharmaceutical company committed to providing responsible solutions to advance patient care in oncology. Our vision is to identify, develop and deliver to patients important new therapies for diseases with significant unmet need. This commitment is epitomized by our lead clinical candidate, zotiraciclib (ZTR), which is initially being developed for the treatment of high-grade gliomas (HGG) and diffuse intrinsic pontine glioma (DIPG), two forms of brain cancer characterized by Myc overexpression. ZTR has been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of gliomas. Adastra possesses a rich history of institutional and academic collaboration, including ongoing clinical research programs with the National Cancer Institute (NCI) and the European Organisation for Research and Treatment of Cancer (EORTC). We invite you to learn more about Adastra, our clinical and scientific partners and our journey to bring meaningful new therapies to patients, by visiting www.adastrarx.com.Print
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