VIENNA, Va.--(BUSINESS WIRE)--The following letter is being released by CEL-SCI Corporation (NYSE MKT:CVM) to its shareholders:
Dear Fellow Shareholders:
We are giving you an update on clinical hold communications with the U.S. Food and Drug Administration (FDA), the “Agency”, regarding the previously announced partial clinical hold of CEL-SCI's Phase 3 clinical trial of its investigational drug Multikine* (Leukocyte Interleukin, Injection) in patients with squamous cell carcinoma of the head and neck.
The partial clinical hold on this ongoing Phase 3 head and neck cancer trial with 928 patients enrolled covered a range of issues previously described to the shareholders. Following a Type A meeting with the FDA in February 2017, we filed a response that was intended to address all of these issues in April, 2017. As part of our response to address the FDA concerns expressed in item 3 of the October 15, 2016 letter from the FDA to us, we submitted a proposed update to the Investigator’s Brochure (IB) and a proposed “Dear investigator” letter which we planned to distribute following the FDA’s review and approval. In its most recent communication in May 2017, the FDA stated: “We have completed the review of your April 19, 2017, submission and have concluded that removal of the clinical hold is not warranted since item 3 of the October 15, 2016 letter has not been resolved. In addition, we have identified new deficiencies in your April 19, 2017, submission.” The FDA directed that: 1) The IB and the “Dear investigator” letter should contain specific statements and data which were not included in the proposed texts we had submitted in April 2017 and 2) Some of the statements that were included in the proposed texts accompanying our April 2017 response should be removed. Work on revising the IB and the “Dear investigator” letter in accordance with the FDA’s directions has already begun and we hope to resubmit the amended documents to the FDA for their review and approval very soon. We are hopeful that the FDA will consider the amended documents satisfactory and will consider lifting the clinical hold.
In the Agency’s May 2017 letter, the FDA also stated: “Until you have submitted the required information and we notify you that you may initiate clinical studies, this IND remains on clinical hold and you may not legally initiate or resume clinical studies under it.” The heading on the FDA May 2017 letter is “Continue Full Clinical Hold”, whereas the heading on previous hold letters was “Partial Clinical Hold”. The FDA communicated to us that the IND is on Full Clinical Hold because the exception to the full hold (Patients enrolled in our Phase 3 head and neck cancer protocol prior to September 26, 2016, may continue to receive protocol-specified treatment at the discretion of the treating physician) no longer exists, since all patients had completed planned treatment with our investigational product, Multikine. Placing the IND on full hold does not result in termination of the Phase 3 head and neck cancer trial and all protocol-specified data collection will continue as described in the protocol, but we may not enroll new patients and may not resume investigational product (Multikine) dosing in any previously enrolled patient. In the Agency’s May 2017, letter, the FDA stated, “Finally, since there are no patients currently receiving Multikine under this IND and the only study being conducted under this IND (Study CA001P3) is closed to accrual, we have concluded that all studies covered by this IND must be placed on clinical hold; proposed studies may not be initiated, and ongoing studies are suspended.” It should be noted that, at present, CEL-SCI is not conducting other studies with Multikine under this IND other than the ongoing Phase 3 study which is subject to the clinical hold, no other studies are planned in the immediate future, and an amendment to the Phase 3 head and neck cancer study will be filed only if required. Our study investigating the use of Multikine as a potential treatment in HPV related disease is being conducted under a different IND.
We are continuing to work extremely hard to bring our Phase 3 trial to a successful conclusion, to have the FDA's clinical hold lifted, and to win the arbitration case against the former CRO that originally ran our Phase 3 trial.
We thank you for your continued support of the Company.
Chief Executive Officer
This letter contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this letter, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K and 10-K/A for the year ended September 30, 2016. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress and that is currently subject to a clinical hold.