Full Press Release Details
Biosciences Announces Approval from Israel's Ministry of Health to Begin its Phase 1/2 Trial of Triple-Combination CBD Treatment
Enters into Clinical Stage Development of Lead Asset, EV101, in Israel with MOH Approval
Fla., July 8, 2021 - 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.
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."
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.
study design is as follows:
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."
product is not approved for marketing anywhere in the world.
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/.
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.
Pinto / Allison Soss
Strategic Communications
Kasunich / Raquel Cona
Strategic Communications