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LONDON, UK / ACCESSWIRE / March 8, 2017 / Active Wall St. blog coverage looks at the headline from CEL-SCI Corp. (NYSE: CVM) as the Company announced on March 06, 2017, that it has received the official minutes from its February 08, 2017 meeting with the US Food and Drug Administration (FDA) in regards to the partial clinical hold placed on the Phase-3 head and neck cancer study with CEL-SCI's investigational drug Multikine (Leukocyte Interleukin, Injection) on September 26, 2016. Register with us now for your free membership and blog access at:

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One of CEL-SCI's competitors within the Biotechnology space, TESARO, Inc. (NASDAQ: TSRO), reported on February 28, 2017 its operating results for Q4 2016 and provided an update on the Company's development programs. AWS will be initiating a research report on TESARO in the coming days.

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CEL-SCI announced that pursuant to this partial clinical hold, patients currently receiving study treatments can continue to receive treatment at the discretion of their physicians and with their consent, and patients already enrolled in the study will continue to be followed. 928 patients are enrolled in this study.

Meeting Details

CEL-SCI stated that the purpose of the Type A (face-to-face) meeting with the FDA was to allow discussion of the clinical hold issues raised by the FDA and to secure the FDA's input and clarification on how to address the partial hold issues. The Action Items for CEL-SCI to pursue per the minutes from the FDA were the following:

1) To provide an updated Investigator's Brochure and current procedures for compliance with requirements under 21 CFR 312 Subpart D to address the partial clinical hold.

2) To provide a list of major protocol deviations, which CEL-SCI believes will affect study results, and provide a plan to identify major protocol deviations across all patients enrolled in the Phase-3 protocol.

CEL-SCI noted that it is giving the FDA issues top priority. The Company believes that addressing the Action Items listed will support a favorable decision by the FDA to lift the partial clinical hold. However, the Company also warned that all of the work is subject to the FDA's review of its submission upon its completion and may or may not result in the lifting of the partial clinical hold.

Raises Capital for Phase-3 Study

As per a SEC filing dated February 17, 2017, CEL-SCI entered into a securities purchase agreement with institutional investors on February 16, 2017, whereby it sold 10,000,000 shares of its common stock for aggregate gross proceeds of $1,000,000, or $0.10 per share, in a registered direct offering. In a concurrent private placement, CEL-SCI sold to the purchasers of CEL-SCI's common stock referred to in Item 1.01 warrants (Series GG) to purchase 10,000,000 shares of CEL-SCI's common stock. The warrants can be exercised at a price of $0.12 per share at any commencing six months after the date of issuance and ending five and a half years after the date of issuance.

The net proceeds to CEL-SCI from the transaction, after deducting the placement agent's fees and expenses and CEL-SCI's estimated offering expenses, are expected to be approximately $830,000. The Company intends to use the net proceeds from the offering for the Phase-3 clinical study and general corporate purposes.

Stock Performance

At the close of trading session on Tuesday, March 07, 2017, CEL-SCI's stock price rose 2.03% to end the day at $0.12. A total volume of 4.23 million shares were exchanged during the session, which was above the 3-month average volume of 3.19 million shares. The Company's share price has soared 65.43% on YTD basis. The stock currently has a market cap of $23.49 million.

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SOURCE: Active Wall Street