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News Article | May 10, 2017
Site: www.businesswire.com

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT: CVM) today reported financial results for the quarter ended March 31, 2017. CEL-SCI's net loss available to common shareholders for the quarter ended March 31, 2017 was ($8,409,489) or ($0.05) per basic and diluted share, versus ($8,844,855) or ($0.07) per basic and diluted share during the quarter ended March 31, 2016. The net loss available to common shareholders for the six months ended March 31, 2017 was ($4,872,687) or ($0.03) per basic and diluted share, versus ($6,503,042) or ($0.06) per basic and diluted share during the same six months ended March 31, 2016. During the six months ended March 31, 2017, the Company’s cash decreased by approximately $1.4 million. Significant components of this decrease include net proceeds from the sale of the Company’s stock of approximately $5.8 million offset by net cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $7.2 million. CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. Its lead investigational immunotherapy, Multikine* (Leukocyte Interleukin, Injection), is currently being studied in a pivotal Phase 3 clinical trial as a potential neoadjuvant treatment for patients with squamous cell carcinoma of the head and neck. Subject to the partial clinical hold, the study was designed with the objective that, if the study endpoint, which is an improvement in overall survival of the subjects treated with the Multikine treatment regimen plus the current standard of care (SOC) as compared to subjects treated with the current SOC only, is satisfied, the study results will be used to support applications that the Company plans to submit to regulatory agencies in order to seek commercial marketing approvals for Multikine in major markets around the world. CEL-SCI has patents on Multikine from the US, Europe, China, and Japan. CEL-SCI is also developing its pre-clinical L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology for the potential treatment of pandemic influenza in hospitalized patients and as a potential vaccine for the treatment of rheumatoid arthritis. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland. This press release 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 press release, 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 on enrollment of additional new patients.


News Article | May 12, 2017
Site: www.businesswire.com

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT: CVM) today announced it has changed the date for its annual meeting from June 9, 2017 to June 12, 2017. The Company’s annual meeting is now scheduled for Monday, June 12, 2017 at 10:30 a.m. local time. The meeting will be held at 4820-C Seton Drive, Baltimore, MD 21215. No changes have been made to the record date or the proposals to be brought before the annual meeting, which are presented in the Proxy Statement that the Company filed with the Securities and Exchange Commission (SEC) on April 27, 2017. Stockholders who have already submitted a proxy or voting instructions do not need to take any further action. The Company's Proxy Statement and Annual Report filed by the Company with the SEC are available on the SEC's website at http://www.sec.gov. CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.


News Article | May 16, 2017
Site: www.businesswire.com

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT:CVM) today announced that Daniel Zimmerman, Ph.D., Senior Vice President of Research, Cellular Immunology, presented additional data on its LEAPS rheumatoid arthritis (RA) vaccine candidates CEL-4000 and CEL-2000 at IMMUNOLOGY 2017, the annual meeting of the American Association of Immunologists (AAI), May 12 – 16 in Washington, D.C. The title of his poster is “Key serum cytokine markers for evaluating the efficacy of vaccine therapy in autoimmune models of rheumatoid arthritis.” The abstract can be viewed online or found through the conference website at: www.immunology2017.org. Dr. Zimmerman and the research team concluded that serum concentrations and ratios of key disease-related cytokines can predict therapeutic efficacy in different animal models of RA. The data showed that a reduced RA disease progression was observed in mice treated with LEAPS vaccines and was accompanied by decreased pro-inflammatory cytokines level and increased ratios of anti-inflammatory/regulatory to pro-inflammatory cytokines. Thus, a successful vaccine therapy appears to be associated with a ratio shift in favor of anti-inflammatory/regulatory cytokines. The ability to predict cytokine responses to therapy should allow for better design or choice of the appropriate immunomodulatory LEAPS vaccines and other therapies in RA. L.E.A.P.S. (Ligand Epitope Antigen Presentation System) is a CEL-SCI patented platform technology designed to stimulate antigen-specific immune responses in T-cells using synthetic peptides. LEAPS constructs physically link the antigenic peptide with a T-cell binding ligand and are delivered directly to the recipient by injection or through absorption onto mucosal surfaces, potentially enhancing T-cell responses to a particular antigen. CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland. This press release 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 press release, 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.


News Article | May 24, 2017
Site: www.businesswire.com

VIENNA, Va.--(BUSINESS WIRE)--The following letter is being released by CEL-SCI Corporation (NYSE MKT:CVM) to its 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. 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.


News Article | April 24, 2017
Site: www.businesswire.com

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation releases letter to shareholders.


News Article | February 27, 2017
Site: www.businesswire.com

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT: CVM) announces that the NYSE MKT (the “Exchange”) has accepted the Company’s plan to bring itself into compliance with the Exchange's continued listing standards. The Company previously received notice from the Exchange on December 9, 2016, indicating the Company is below compliance with Section 1003(a)(i), Section 1003(a)(ii) and Section 1003(a)(iii) since it reported a stockholders’ equity deficit as of June 30, 2016 and had a net losses in its 5 most recent fiscal years ended September 30, 2015. The Company was afforded the opportunity to submit a plan to regain compliance, and on January 9, 2017 the Company submitted its plan to the Exchange. On February 24, 2017 the Exchange notified the Company that it accepted the Company's plan of compliance and granted the Company until June 11, 2018 to regain compliance with the continued listing standards. The Company will be subject to periodic review during this period. Failure to make progress consistent with the plan or to regain compliance with the continued listing standards by the end of the period could result in the Company being delisted from the NYSE MKT. The Company may then appeal a staff determination to initiate such proceedings in accordance with the exchange's Company Guide. CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland. This press release 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 press release, 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. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. 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.


News Article | February 17, 2017
Site: www.businesswire.com

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT:CVM) today announced it has entered into a definitive agreement with institutional investors for an offering of shares of common stock with gross proceeds of approximately $1.0 million in a registered direct offering. The closing of the offering is expected to take place on or about February 23, 2017, subject to the satisfaction of customary closing conditions. In connection with the offering, the CEL-SCI will issue approximately 10 million registered shares of common stock at a purchase price of $0.10 per share. Concurrently in a private placement, the Company will issue warrants to purchase up to shares of its common stock. For each share of common stock purchased by an investor, such investor in the private placement will receive from the CEL-SCI an unregistered warrant to purchase one share of common stock. The warrants have an exercise price of $0.12 per share, will be exercisable upon the 6 month anniversary of the issue date, and will expire five and a half years from the issue date. Rodman & Renshaw, a unit of H.C. Wainwright & Co., LLC, is acting as the exclusive placement agent in connection with the offering. CEL-SCI intends to use the net proceeds from the offering for the Phase 3 clinical study and general corporate purposes. The shares of common stock described above (but not the warrants or the shares of common stock underlying the warrants) are being offered pursuant to a “shelf” registration statement (File No. 333-205444). Such shares of common stock may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. A prospectus supplement and the accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at http://www.sec.gov. Copies of the prospectus supplement, when filed with the SEC, and accompanying prospectus relating to this offering may also be obtained from H.C. Wainwright & Co., LLC, by emailing placements@hcwco.com or by calling 646-975-6996. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. Its lead investigational immunotherapy, Multikine* (Leukocyte Interleukin, Injection), is currently being studied in a pivotal Phase 3 clinical trial as a potential neoadjuvant treatment for patients with squamous cell carcinoma of the head and neck. Subject to the partial clinical hold, the study was designed with the objective that, if the study endpoint, which is an improvement in overall survival of the subjects treated with the Multikine treatment regimen plus the current standard of care (SOC) as compared to subjects treated with the current SOC only, is satisfied, the study results will be used to support applications that the Company plans to submit to regulatory agencies in order to seek commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine that are being investigated include the treatment of cervical dysplasia in HIV/HPV co-infected women, and the treatment of peri-anal warts in HIV/HPV co-infected men and women. A Phase 1 trial of the former indication (treatment of cervical dysplasia in HIV/HPV co-infected women) has been completed at the University of Maryland. The latter indication (treatment of peri-anal warts in HIV/HPV co-infected men and women) is being studied in a Phase 1 trial at the University of California, San Francisco. CEL-SCI has patents on Multikine from the US, Europe, China, and Japan. CEL-SCI is also developing its pre-clinical L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology for the potential treatment of pandemic influenza in hospitalized patients and as a potential vaccine for the treatment of rheumatoid arthritis. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland. This press release 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 press release, 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. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. 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 on enrollment of additional new patients.


News Article | December 14, 2016
Site: www.businesswire.com

VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported financial results today for the fiscal year ended September 30, 2016. The Company also reported key clinical and corporate developments achieved during and subsequent to fiscal 2016. CEL-SCI reported a net loss of ($11.46) million in fiscal year 2016 versus a net loss of ($34.67) million in fiscal 2015. CEL-SCI reported an operating loss of ($25.55) million in fiscal year 2016 versus an operating loss of ($34.30) million in fiscal year 2015. The reduction in operating loss was largely attributable to a decrease in general and administrative expenses to $6.5 million in fiscal year 2016 compared to $13.9 million in fiscal year 2015. Major components of the decrease are 1) Lake Whillans Litigation Finance took over payment of legal fees which were about $4.4 m in fiscal year 2015 in the arbitration against the former CRO that used to run the Company’s Phase 3 trial, 2) a $2.8 million decrease in share-based employee compensation costs, which relates to the timing of vesting for the incentive stock bonus plan and 3) other miscellaneous decreases netting to approximately $200,000. Geert Kersten, CEL-SCI’s Chief Executive Officer said, “Our full focus is on two issues very important to our company: 1) the release of the partial clinical hold on the Company’s Phase 3 trial and 2) bringing to a successful conclusion the arbitration against the former CRO that used to run the Phase 3 study. That hearing on the merits, which is equivalent to a trial in a court case, started on September 26, 2016 and is ongoing.” CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. Its lead investigational immunotherapy, Multikine* (Leukocyte Interleukin, Injection), is currently being studied in a pivotal Phase 3 clinical trial as a potential neoadjuvant treatment for patients with squamous cell carcinoma of the head and neck. Subject to the partial clinical hold, the study was designed with the objective that, if the study endpoint, which is an improvement in overall survival of the subjects treated with the Multikine treatment regimen plus the current standard of care (SOC) as compared to subjects treated with the current SOC only, is satisfied, the study results will be used to support applications that the Company plans to submit to regulatory agencies in order to seek commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine that are being investigated include the treatment of cervical dysplasia in HIV/HPV co-infected women, and the treatment of peri-anal warts in HIV/HPV co-infected men and women. A Phase 1 trial of the former indication (treatment of cervical dysplasia in HIV/HPV co-infected women) has been completed at the University of Maryland. The latter indication (treatment of peri-anal warts in HIV/HPV co-infected men and women) is being studied in a Phase 1 trial at the University of California, San Francisco. CEL-SCI has patents on Multikine from the US, Europe, China, and Japan. CEL-SCI is also developing its pre-clinical L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology for the potential treatment of pandemic influenza in hospitalized patients and as a potential vaccine for the treatment of rheumatoid arthritis. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland. This press release 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 press release, 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 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 on enrollment of additional new patients.


VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT:CVM) today announced that Dr. Daniel Zimmerman, its Senior V.P of Research, Cellular Immunology, presented data with a LEAPS Rheumatoid Arthritis therapeutic (treatment) vaccine at Madridge‘s International Conference on Vaccines held in Baltimore, MD on February 20-22, 2017. At the conference Dr. Zimmerman presented a potentially novel approach to fighting the inflammation in the joints caused by Rheumatoid Arthritis. He introduced animal data that demonstrates that using CEL-SCI’s L.E.A.P.S CEL-4000 Rheumatoid Arthritis treatment vaccine downregulates pro-inflammatory T-cell responses and upregulates anti-inflammatory T-cell responses. This finding was confirmed by an examination of cytokines in the serum of the animals. This demonstrates that LEAPS CEL-4000 has the potential for use as a therapeutic vaccine to treat certain types of Rheumatoid Arthritis if these results can be confirmed in human studies. The study was conducted in collaboration with Dr. Tibor Glant's research team at Rush University Medical Center. Dr. Glant holds the "Jorge O. Galante, MD" Endowed Chair Professorship in Orthopedic Surgery at Rush. The Proteoglycan induced arthritis (PGIA) animal model was developed and has been studied extensively in Dr. Glant's laboratory at Rush University Medical Center for over 25 years and is considered to be closely related to the human condition of many Rheumatoid Arthritis patients. The PGIA model exhibits rheumatoid factor (Rf) and Rheumatoid Arthritis -specific antibodies not seen in other Rheumatoid Arthritis models. The LEAPS vaccines in this preliminary study consisted of a disease epitope (portion of a disease associated antigen protein) attached to a portion of another very small peptide immune cell binding ligand (ICBL) chosen to promote and direct the immune response away from a Th1 response. When the ICBL and the disease-related Proteoglycan epitope were conjugated to each other, one of the LEAPS vaccines promoted protective immune responses reduced arthritis symptoms in the animals. Rheumatoid arthritis is a chronic inflammatory disease that mainly targets the synovial membrane, cartilage and bone. It affects about 1% of the global population and is associated with significant morbidity and increased mortality. CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland. This press release 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 press release, 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.


NEW YORK, February 16, 2017 /PRNewswire/ -- In today's pre-market research, Stock-Callers.com has issued research reports on Heat Biologics Inc. (NASDAQ: HTBX), PDL BioPharma Inc. (NASDAQ: PDLI), Achaogen Inc. (NASDAQ: AKAO), and CEL-SCI Corp. (NYSE MKT: CVM). These companies belong...

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