HOUSTON and TORONTO, April 13, 2017 /PRNewswire/ - Medicenna BioPharma Inc. ("Medicenna"
"Dosing the first patient in this clinical trial is a significant milestone for the Company as we look to build upon the promising results from earlier studies with MDNA55," said Dr. Fahar Merchant, Chairman and CEO of Medicenna. "We are pleased to be working with leading neuro-surgical centers in the U.S. as we explore the benefits of MDNA55 for the treatment of rGB and other types of brain cancer."
MDNA55 is a targeted form of immunotherapy designed to purge tumor cells and adjacent immunosuppressive cells in the tumor microenvironment that over-express the interleukin-4 receptor (IL4R), which is common in a majority of patients with rGB. By directly eliminating tumor cells and boosting a therapeutic immune response in rGB patients, MDNA55 provides a two-pronged approach to treat brain cancer patients.
"We are delighted to have included the first patient in this important study," said Dr. Andrew Brenner, Clinical Investigator, Institute of Drug Development at UT Health San Antonio Cancer Center. "The state-of-the-art neuro-surgical and imaging techniques to optimize drug delivery together with MDNA55, which simultaneously targets killing of cancer cells and boosts the immune system's response against the tumor, has the potential to alter the treatment paradigm for brain cancer. Our participation in this trial puts Cancer Therapy and Research Center in San Antonio at the forefront of efforts to find new treatments for this terrible disease," added Dr. John Floyd, Neurosurgeon and Interim Chair, Department of Neurological Surgery.
Study DesignThe multi-center, single-arm, open-label, Phase 2 investigation of MDNA55 (ClinicalTrials.gov identifier: NCT02226965) will enroll approximately 43 adult patients with glioblastoma who have progressed or recurred following previous therapy. Patients will be administered MDNA55 by a single intra-tumoral infusion using convection enhanced delivery (CED), a minimally invasive technique used to by-pass the blood brain barrier. The use of precision image guided CED is anticipated to deliver the drug to the tumor and its microenvironment while dramatically reducing systemic side effects.
The primary endpoint is overall response rate (ORR), assessed by magnetic resonance imaging using the Revised Assessment in Neuro-Oncology (RANO) criteria. Secondary outcome measures include progression-free survival, overall survival, and exploratory predictors of outcome assessed by IL4R expression in archived tumor biopsies.
The study will be conducted in approximately ten sites in the United States. Patient enrolment is expected to be completed before the end of 2017 with top-line results anticipated in the first half of 2018.
To learn more about the clinical trial visit https://clinicaltrials.gov/show/NCT02858895.
About MDNA55 MDNA55 is a targeted form of immunotherapy designed to purge tumor cells and adjacent immunosuppressive cells in the tumor microenvironment that over-express the interleukin-4 receptor (IL4R), which is common in a majority of patients with glioblastoma and other aggressive forms of brain cancer. By directly eliminating tumor cells and boosting a therapeutic immune response, MDNA55 provides a two-pronged approach to treat brain cancer patients. MDNA55 has received Fast Track Designation from the FDA and Orphan Drug Status from both the FDA and EMA. Earlier results from three Phase 1 and 2a clinical trials in 66 patients with glioblastoma showed potent anti-tumor effects without drug-related systemic toxicity in the majority of patients.
A summary of clinical data from earlier Phase 1 and 2 clinical trials can be found on Medicenna Therapeutics Corp.'s website at http://www.medicenna.com/Our-Lead-Program/Clinical-Development/default.aspx.
About GlioblastomaWorldwide, there are an estimated 240,000 cases of brain and central nervous system cancers per year, of which glioblastoma (GB) is the most common and the most lethal. Of the approximately 18,000 patients diagnosed with GB every year in the US alone, 13,000 will die of the disease despite an aggressive treatment approach that includes surgery, radiation therapy and chemotherapy. As such, a significant unmet need exists for this form of brain cancer.
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 the expansion of the clinical program to other types of brain cancer, that MDNA55 provides a two-pronged approach to treat brain cancer patients, that MDNA55 has the potential to alter the treatment paradigm for brain cancer, that we expect enrolment to be completed by the end of calendar 2017 with top-line results anticipated in the first half of 2018, future plans and objectives of the Company 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 filing statement of the Company dated February 27, 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.
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