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Editas Medicine Announces the Completion of the Recombinant DNA Advisory Committee (RAC) Registration Process
CAMBRIDGE, Mass., Aug. 16, 2018 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (NASDAQ: EDIT), a leading genome editing company, announced today the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC) completed the NIH protocol registration process for EDIT-101. The NIH determined a public meeting is not necessary, and the RAC will not be convened to review this clinical trial.
EDIT-101 is Editas Medicine’s experimental CRISPR genome editing medicine for the treatment of Leber Congenital Amaurosis type 10 (LCA10). Editas Medicine plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in October.
Earlier this month, Editas Medicine and Allergan Pharmaceuticals International Limited (Allergan), announced that Allergan exercised its option to develop and commercialize EDIT-101 globally for the treatment of LCA10. Additionally, the two companies announced that Editas Medicine has exercised its option to co-develop and share equally in the profits and losses from EDIT-101 in the United States.
About Editas Medicine
As a leading genome editing company, Editas Medicine is focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 genome editing systems into a robust pipeline of treatments for people living with serious diseases around the world. Editas Medicine aims to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases. For the latest information and scientific presentations, please visit www.editasmedicine.com.
This press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995. The words “aim,” ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’ ‘‘would,’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements regarding the Company planning to file an IND for EDIT-101 in October. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of the Company’s product candidates; availability and timing of results from preclinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; expectations for regulatory approvals to conduct trials or to market products and availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. These and other risks are described in greater detail under the caption “Risk Factors” included in the Company’s most recent Quarterly Report on Form 10-Q, which is on file with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.