Adastra Pharmaceuticals Announces that Data from Phase 1b Clinical Trial of Zotiraciclib Will Be Presented at ASCO 2019

17 May 2019

National Cancer Institute (NCI) Study Designed to Investigate Zotiraciclib in Combination with Temozolomide (TMZ) for the Treatment of Recurrent Malignant Gliomas

PRINCETON, N.J. and SAN DIEGO, May 16, 2019 /PRNewswire/ -- Adastra Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of proprietary medicines for the treatment of cancer, today announced that data from a Phase 1b trial of the company's lead clinical candidate, zotiraciclib (TG02), will be the subject of a poster presentation at the 2019 ASCO Annual Meeting being held in Chicago May 31 to June 4, 2019.

The poster session, entitled, "Phase I trial of TG02 plus dose-dense or metronomic temozolomide for recurrent anaplastic astrocytoma and glioblastoma in adults," will detail results from a clinical trial investigating TG02 (zotiraciclib) in combination with temozolomide (TMZ) for the treatment of recurrent malignant gliomas.  The multi-arm, dose-ranging study, which involved 38 patients, was designed to determine the maximum tolerated dose and the toxicity profile of the combination of TG02 and TMZ.  The primary endpoint was the dose limiting toxicity from the start of the combined treatment to four weeks after completion of each arm.

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), will present the poster. 

"We are very pleased that data from the first of three Phase 1b clinical trials of zotiraciclib in glioma indications will be presented during ASCO 2019," said Scott Megaffin, Chief Executive Officer of Adastra.  "Designed as an orally delivered molecule which readily crosses the blood brain barrier, zotiraciclib possesses a unique mechanism of action that depletes Myc through the inhibition of CDK9.  Myc overexpression is a known factor in myriad cancers, with 80 percent of gliomas characterized by this property.  Given the potential of zotiraciclib to address these cancers, many of which are associated with poor prognoses and tumor resistance, Adastra is currently working to advance three distinct Phase 1bclinical trials, two in glioblastoma multiforme (GBM) and one in Diffuse Intrinsic Pontine Glioma (DIPG), a rare pediatric cancer."   

Poster Presentation Details

Title:

Phase I trial of TG02 plus dose-dense or metronomic temozolomide for recurrent anaplastic astrocytoma and glioblastoma in adults

Session:

Central Nervous System Tumors

Abstract Number:

2031

Date:

June 2, 2019

Time:

8:00 AM – 11:00 AM, CDT

Location:

McCormick Place, Chicago, IL

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, as well as breast, ovarian, colorectal, pancreatic, and gastric cancer.  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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