Interim Top-Line Results to be Announced in June,
2019
TORONTO and HOUSTON, April 30,
2019 /CNW/ - Medicenna Therapeutics Corp. ("Medicenna" or
the "Company") (TSX: MDNA; OTCQB: MDNAF), a clinical stage
immuno-oncology company, is pleased to announce that it has
completed enrolment in the Phase 2b
clinical study of MDNA55 for the treatment of recurrent
glioblastoma (rGBM), the most common and uniformly fatal form of
brain cancer.
"The completion of patient enrolment with our flagship clinical
asset is a significant milestone for Medicenna and we look forward
to reporting interim top-line data from this trial in June 2019." said Dr. Fahar Merchant, Chairman, President and CEO,
"Glioblastoma is a devastating disease and it is particularly
aggressive in patients overexpressing the IL4 receptor (IL4R), a
biomarker that is specifically targeted by MDNA55. The interim
results we presented in February 2019
demonstrated that a single low dose treatment with MDNA55 was able
to extend survival by 2-fold to 15.2 months in rGBM patients
expressing the IL4R when compared to expected survival of 6 to 8
months. We would like to thank our shareholders for their patience,
the Cancer Prevention and Research Institute of Texas (CPRIT) for a generous grant,
investigators, clinical sites, patients and their families for
their continued support to bring MDNA55 to patients who need it the
most."
The Company is now evaluating data from 25 patients with rGBM
treated at the high dose and assessing the impact of IL4R
expression on survival outcomes as well as tumor response. Interim
top-line results for all patients will be announced this quarter.
To date MDNA55 has been used to treat more than 130 patients in
multiple clinical trials, including more than 110 patients with
rGBM, building a significant safety profile, evidence of anti-tumor
effect and mechanistic dataset. Medicenna expects multiple
presentations of clinical results at relevant conferences this year
and provide updates following meetings with regulatory agencies
regarding future path to commercialization of MDNA55.
MDNA55, an IL4R directed toxin, has been the subject of a Phase
2b open-label study in up to 52
patients with glioblastoma (GBM) at first or second relapse. In the
study, investigators administered MDNA55 only once directly into
the brain tumor using a technique known as Convection Enhanced
Delivery (CED). CED allows precision delivery of MDNA55 directly
into the tumor tissue and the surrounding healthy brain containing
infiltrative tumor cells, while avoiding exposure to the rest of
the body. Retrospective analysis of GBM tissue obtained at first
diagnosis is performed by immunohistochemistry for
IL-4Ra expression. Biopsy samples are categorized based on
IL4Rα expression levels and compared against survival outcomes.
About Medicenna
Medicenna is a clinical stage immunotherapy company developing
novel highly selective versions of IL-2, IL-4 and IL-13 Superkines
and first in class Empowered Cytokines™ (ECs). Our mission is to
become the leader in the development and commercialization of ECs
and Superkines for the treatment of a broad range of cancers and
immune-mediated diseases. MDNA55 is Medicenna's lead EC that has
completed enrolling in a multi-centre Phase 2b clinical trial for the treatment of recurrent
glioblastoma (rGBM), the most common and uniformly fatal form of
brain cancer. MDNA55 has secured Orphan Drug Status from the United
States Food and Drug Administration (FDA) and the European
Medicines Agency as well as Fast Track Designation from the FDA for
the treatment of rGBM. 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
related to the Phase 2b clinical
trial of MDNA55 for the treatment of rGBM including, without
limitation, top line data reporting timelines, and
the future plans and objectives of the Company, 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
26, 2018 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 (including, without
limitation, the ability of the Company to fully replicate these
interim data results) 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.
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SOURCE Medicenna Therapeutics Corp.