NAPLES, Fla., July 8, 2021 /PRNewswire/ -- Enveric
Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"),
a patient-first biotechnology company developing novel cannabinoid
medicines to improve quality of life for cancer
patients, announced today that the Company has received
approval from the Israeli Ministry of Health to begin the Phase 1/2
portion of its study of its lead asset, EV101, designed to
investigate the safety and efficacy of synthetic cannabidiol (CBD)
when administered alone or in combination with clomiphene,
concurrently with temozolomide, to treat patients suffering from
recurrent or progressive glioblastoma (GBM). The study will be
conducted at the Davidoff Institute of Oncology, Rabin Medical
Center, in Israel under Principal
Investigator Dr. Tali Siegal.
"Glioblastoma is a highly aggressive form of cancer with a very
poor overall survival rate, particularly for those with recurrent
GBM, which is the target group for this study," said Robert Wilkins, M.D., Chief Medical Officer,
Enveric Biosciences. "Our goal with this study is to enhance the
existing treatment's efficacy through adding CBD to create a new
standard of care, potentially improving and extending glioblastoma
patients' quality of life."
The Phase 1 portion of the study is intended to first determine
the CBD-temozolomide combination's maximum tolerated dose (MTD).
Clomiphene will then be added to the regimen for up to 24 patients
to rule out toxicity. Once all three agents' MTDs are determined,
they will then be applied to the Phase 2 portion to determine
initial efficacy, where an additional 40 patients are expected to
be recruited and randomized into two open-label treatment arms.
The study design is as follows:
- Arm 1 (combination): Patients will be treated with the MTD
determined in the dose-finding phase for pure synthetic CBD oil +
temozolomide.
- Arm 2 (triple combination): Patients will be treated with
the MTD determined in the dose-finding phase for pure synthetic CBD
oil + temozolomide + clomiphene.
- All patients will continue treatment for up to 24 months from
Day 1 of the therapy unless unacceptable toxicities, patient
consent withdrawal or death occur.
"We believe that the Israeli Ministry of Health's approval for
this Phase 1/2 study is a major milestone not only for Enveric but
also for glioblastoma patients globally who are seeking to prolong
their survival and improve their quality of life," added
David Johnson, Chairman and CEO of
Enveric Biosciences. "Our goal is to further demonstrate CBD's
efficacy when combined with current anti-cancer drugs to optimize
the existing standard-of-care for cancer patients in need. We are
targeting the fourth quarter of 2021 for the enrollment of our
first patient, following the conclusion of the final study
agreements with the site."
This product is not approved for marketing anywhere in the
world.
About Enveric Biosciences
Enveric Biosciences is a
patient-first biotechnology company developing rigorously tested,
novel cannabinoid medicines to improve quality of life for cancer
patients. Initial indications include radiodermatitis, a common and
often severe side effect of radiation therapy, and
chemotherapy-induced neuropathy. For more information, please visit
https://www.enveric.com/.
Forward-Looking Statements
This press release
contains forward-looking statements and forward-looking information
within the meaning of applicable securities laws. These statements
relate to future events or future performance. All statements other
than statements of historical fact may be forward-looking
statements or information. Generally, forward-looking statements
and information may be identified by the use of forward-looking
terminology such as "plans", " expects" or "does not expect",
"proposed", "is expected", "budgets", "scheduled", "estimates",
"forecasts", "intends", "anticipates" or "does not anticipate", or
"believes", or variations of such words and phrases, or by the use
of words or phrases which state that certain actions, events or
results may, could, would, or might occur or be achieved.
Forward-looking statements consist of statements that are not
purely historical, including any statements regarding beliefs,
plans, expectations or intentions regarding the future. Such
forward-looking statements are based on the beliefs of management
as well as assumptions made by and information currently available
to management. Actual results could differ materially from those
contemplated by the forward-looking statements as a result of
certain factors, including, but not limited to, the impact of the
novel coronavirus (COVID-19) on Enveric's ongoing and planned
clinical trials; the geographic, social and economic impact of
COVID-19 on Enveric's ability to conduct its business and raise
capital in the future when needed; delays in planned clinical
trials; the ability to establish that potential products are
efficacious or safe in preclinical or clinical trials; the ability
to establish or maintain collaborations on the development of
therapeutic candidates; the ability to obtain appropriate or
necessary governmental approvals to market potential products; the
ability to obtain future funding for developmental products and
working capital and to obtain such funding on commercially
reasonable terms; Enveric's ability to manufacture product
candidates on a commercial scale or in collaborations with third
parties; changes in the size and nature of competitors; the ability
to retain key executives and scientists; and the ability to secure
and enforce legal rights related to Enveric's products, including
patent protection. A discussion of these and other factors,
including risks and uncertainties with respect to Enveric, is set
forth in Enveric's filings with the Securities and Exchange
Commission (SEC), including the Company's Annual Report on Form
10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any
intention or obligation to revise any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as required by law.
Investor Contacts
Valter
Pinto / Allison Soss
KCSA Strategic Communications
212.896.1254 / 212.896.1267
valter@kcsa.com / asoss@kcsa.com
Media Contacts
Caitlin
Kasunich / Raquel Cona
KCSA Strategic Communications
212.896.1241 / 212.896.1204
ckasunich@kcsa.com / rcona@kcsa.com
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SOURCE Enveric Biosciences