Medicenna Presents Clinical Data From Previous Phase 1 and 2 Clinical Trials of MDNA55
Nov 14, 2017, 07:00 ET
TORONTO and HOUSTON, TX, Nov. 14, 2017 /CNW/ - Medicenna Therapeutics Corp. ("Medicenna" or "the Company") (TSX "MDNA"), a clinical stage immuno-oncology company, announced that that Dr. Martin Bexon, MD, Head of Clinical Development at Medicenna, will present today results from earlier clinical trials at the Cancer Prevention and Research Institute of Texas' ("CPRIT") Fifth Innovations in Cancer Prevention and Research Conference held from November 13-14, 2017 in Austin, TX.
The poster presentation by Dr. Bexon provides an overview of the safety and efficacy results from previous Phase 1 and 2 clinical trials of the targeted immunotherapy, MDNA55, in 66 patients with recurrent glioblastoma (rGBM), the most common and deadly form of brain cancer.
In the MDNA55 Phase 1 multicenter study, an overall response rate (ORR) of 56% was achieved, with a complete response rate of 20%. Rapid tumor necrosis was observed in ~50% of MDNA55 patients with a partial or a complete response indicating MDNA55-depedent tumor cytotoxicity. Comparable ORR with other therapeutics in rGBM patients in various clinical trials has ranged from 4 to 6% (Levin VA, et al., Neuro-Oncology 17:vi1–vi26, 2015).
Analysis of efficacy data, across the MDNA55 Phase 1 and 2 studies, showed a median survival of 210 days post infusion in all rGBM patients irrespective of the number of relapses. Among patients with a partial or complete response median survival was 12.5 months with overall survival at 6 and 12 months (OS-6 and OS-12) of 71% and 57%, respectively, following a single administration of MDNA55.
In addition to promising efficacy data the clinical trial demonstrated the excellent safety profile of MDNA55 including:
- No systemic toxicity following doses of 6 – 900 μg.
- No clinically significant laboratory abnormalities.
- No deaths attributed to MDNA55 in any of the trials.
- Drug-related adverse events were primarily neurological, mostly an aggravation of pre-existing neurological deficits characteristic of patients with GBM
- Most frequent drug-related Adverse Events were cerebral edema and headache following infusion
- The maximum tolerated dose (MTD) was established at 240μg
"It is exciting to review these legacy data from 3 studies of MDNA55 in patients with recurrent glioblastoma, most of which are previously unpublished," said Dr. Martin Bexon, Head of Clinical Development at Medicenna. "They clearly show direct evidence of cytotoxicity by MDNA55 on the tumors, high rates of survival at 6 months and with the number of subjects surviving past 18 months substantially in excess of expectation. It is a privilege to work on bringing this program forward and we at Medicenna are grateful to CPRIT for their support."
About Medicenna Therapeutics Corp.
Medicenna is a clinical stage immuno-oncology company developing novel highly selective versions of IL-2, IL-4 and IL-13 Superkines™ and first in class Empowered Cytokines™ (ECs). Its wholly owned subsidiary, Houston-based Medicenna BioPharma, is specifically targeting the Interleukin-4 Receptor (IL4R), which is over-expressed by at least 20 different types of cancer affecting more than one million new cancer patients every year. Medicenna's lead IL4-EC, MDNA55 is enrolling patients in a Phase 2b clinical trial for rGBM at leading brain cancer centres in the US. MDNA55 has completed 3 clinical trials in 72 patients, including 66 adults with rGBM, demonstrated compelling efficacy and obtained Fast-Track and Orphan Drug status from USFDA. Unlike most other cancer therapies, Medicenna's IL4-ECs have the potential to purge both the tumor and the immunosuppressive tumor microenvironment, offering a unique treatment paradigm for a large majority of cancer patients.
For more information, please visit www.medicenna.com.
This news release contains forward-looking statements relating to the future operations of the Company and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding future plans and objectives of the Company, statements related to the ongoing status of the Phase 2b clinical trial of MDNA55 for the treatment of recurrent glioblastoma and others are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company's expectations include the risks detailed in the annual information form of the Company dated June 15, 2017 and in other filings made by the Company with the applicable securities regulators from time to time.
The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements only as expressly required by Canadian securities law.
SOURCE Medicenna Therapeutics Corp.
For further information: about the Company please contact: Fahar Merchant, President and Chief Executive Officer, 604-671-6673, [email protected]; Elizabeth Williams, Chief Financial Officer, 416-648-5555, [email protected]
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