Adastra Pharmaceuticals Announces Positive Interim Data from Phase 1b Clinical Trial of Zotiraciclib in the Treatment of Recurrent Malignant Gliomas

03 June 2019

National Cancer Institute (NCI) Study Designed to Investigate Zotiraciclib in Combination with Temozolomide (TMZ) Presented During Poster Session at ASCO 2019

Maximum Tolerated Dose of Zotiraciclib (250mg) Elicits Tumor Reduction, Suggesting Activity in Glioblastoma Tumors

PRINCETON, N.J. and SAN DIEGO, June 3, 2019 /PRNewswire/ -- Adastra Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of proprietary medicines for the treatment of cancer, today announced interim data from a Phase 1b trial of the company's lead clinical candidate, zotiraciclib (TG02), in combination with temozolomide (TMZ) for the treatment of recurrent malignant gliomas.  The data, which were the subject of a poster presentation at the 2019 ASCO Annual Meeting, identified the optimal dose for zotiraciclib (250mg) in combination with TMZ, with tumor reduction indicating activity and warranting continued investigation.  

The poster session, entitled, "Phase I trial of TG02 plus dose-dense or metronomic temozolomide for recurrent anaplastic astrocytoma and glioblastoma in adults," was presented by principal investigator, Jing Wu, M.D., Ph.D., Tenure Track Investigator in the Neuro-Oncology Branch at the Center for Cancer Research, National Cancer Institute (NCI).   The multi-arm, dose-finding study, which enrolled 40 patients, was designed to determine the maximum tolerated dose (MTD) and the toxicity profile of the combination of TG02 and TMZ.  Data from the study demonstrated the TG02 dose level of 250mg was the protocol-defined MTD in both Arm 1 and Arm 2.  Further, tumor reduction and durable stable disease suggested activity in this population and supports further investigation. 

"Glioblastoma is one of the most devastating and difficult-to-treat cancers. Current therapies have limited efficacy and patient prognoses are poor, necessitating the development of new treatments with unique mechanisms of action," said Tracy Lawhon, Chief Operating Officer of Adastra and co-author of the poster. "Though still early, the data observed in the Phase 1b trial of TG02 were encouraging and are suggestive of a therapy that is safe and capable of eliciting clinical benefit in glioblastoma tumors."

"The data generated in the Phase 1b trial of zotiraciclib in combination with TMZ were very positive, successfully identifying the maximum tolerated dose of zotiraciclib in the treatment of recurrent malignant gliomas," said Scott Megaffin, Chief Executive Officer of Adastra.  "Moreover, as reported at ASCO 2019, the team of investigators at the NCI observed tumor reduction, which suggested that zotiraciclib elicited activity in the recurrent glioblastoma tumors, a number of them in the second recurrence.  In total, these findings are very encouraging and we look forward to results from the full expansion cohort expected in 2020."

About Adastra Pharmaceuticals

Adastra Pharmaceuticals Inc. is a private clinical-stage oncology company committed to providing responsible solutions to advance patient care in oncology.  Its lead clinical candidate, zotiraciclib (TG02), is initially being developed for the treatment of glioblastoma multiforme (GBM) and diffuse intrinsic pontine glioma (DIPG), two brain cancers characterized by Myc overexpression.  Zotiraciclib is currently the subject of two separate Phase 1b clinical studies in GBM, as well as a Phase 1b pilot study in DIPG.  In addition to GBM and DIPG, zotiraciclib offers Adastra the potential to target multiple cancer indications where Myc overexpression is a known factor, including gliomas and hepatocellular tumors.  Adastra holds worldwide rights to zotiraciclib, excluding China and Russia, and patent protection through 2034 with extensions. To learn more, visit www.adastrarx.com.

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