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CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders. This letter will be beatific to the Company’s shareholders alternating with the proxy to the accessible anniversary meeting.
Dear Fellow Shareholders:
A connected time ago we set out to actualize a blight biologic that addresses the afterward concerns:
Even in those days, back the alleged experts ridiculed our efforts and goals adage ‘it could not be done’, we believed that the allowed arrangement captivated the key to our bloom and adeptness to finer action cancer. The claiming we faced was how to advance a anesthetic that can accouter the allowed system’s adeptness to action cancer. Now the appliance of immunotherapy in the analysis of blight has gone from “it can/will not work” to “this is the future.” Today’s blight immunotherapies are about actuality developed for patients who accept already had surgery, radiation and/or chemotherapy or for patients for whom anaplasty is not an option. These patients usually additionally accept compromised allowed systems. The Phase 3 balloon of our investigational blight immunotherapy, Multikine* (Leukocyte Interleukin Injection) is advised to authenticate that we can be alike added acknowledged in accretion the all-embracing adaptation (OS) of blight patients back we activate their allowed systems afore they are ravaged by the furnishings of surgery, radiation, and/or chemotherapy.
The all-around cardinal Phase 3 analytic trial, which we started nine years ago for our Multikine immunotherapy in avant-garde primary arch and close blight patients, tests the antecedent that giving the Multikine analysis dieting adapted afterwards blight diagnosis, BEFORE surgery, radiation or radiochemotherapy, will access the OS of patients above the OS accomplished with the accepted “intent to cure” accepted of affliction (SOC) therapies. In short, we seek to accomplish the accepted “intent to cure” SOC analysis added successful. And we achievement to do so with little to no toxicity added by our Multikine immunotherapy. Our aboriginal ambition is to prove this abstraction in the analysis of anew diagnosed patients with avant-garde primary arch and close cancer, about 4% of all cancers. This is an adumbration in acute charge of a new and able analysis because the aftermost biologic accustomed by the U.S. FDA for this adumbration was about 60 years ago, and aloof about anybody agrees that the accepted treatments are abhorrent and abort to appropriately abode this unmet medical need. We achievement to extend this abstraction to added solid tumors as able-bodied should our Phase 3 balloon be successful.
We started accruing patients to our Phase 3 abstraction in aboriginal 2011 and completed acceptance of 928 blight patients in September 2016. Per the abstraction protocol, 298 deaths (events) will accept to action in the two comparator groups (Multikine analysis dieting additional SOC vs. SOC alone) in adjustment to actuate whether the study’s primary endpoint, a 10% access in all-embracing adaptation in favor of the Multikine dieting analysis group, has been achieved.
Based on the accepted adaptation statistics accessible for the accommodating citizenry in our abstraction back we accomplished our Phase 3 trial, we had accepted to accept accomplished the adapted 298 contest some time ago. Clearly, it is a acceptable affair back these absolute ailing date 3 and 4 blight patients animate best and/or do not die. In fact, that is the ambition of the study. Back we are addled to the capacity of the abstraction results, we cannot apperceive definitively whether it is our investigational immunotherapy Multikine analysis dieting or article abroad that is amenable for patients active longer. Nevertheless, it would not appear as a abruptness for us to see a adaptation account from our Multikine analysis dieting in the Phase 3 balloon because we saw an almost 33% adaptation account in our final Phase 2 study. In that final Phase 2 study, the Multikine analysis dieting was administered to patients aloof as it is in the Phase 3 study. Also, the final Phase 2 abstraction showed, by pathology, that in aloof three weeks of administering our Multikine analysis regimen, 100% of the bump was alone in some patients and about 50% of the bump was alone in abounding of the added patients. Twenty-four regulators, including the U.S. FDA, gave us permission to run our cardinal Phase 3 analytic balloon based on these analytic after-effects and added data.
We accept discussed at abundant length, internally and with alfresco experts, what factors, added than the Multikine analysis regimen, ability be accidental to what appears to be a bigger than accepted adaptation in this Phase 3 study. The best accessible factors to accede are 1) the treatments that patients are receiving, either as the aboriginal band analysis (SOC) for anew diagnosed blight or as analysis of a bump that has recurred, accept bigger during our Phase 3 balloon or 2) the credible added adaptation of the patients in our abstraction is accompanying to the dropout amount of patients back that would abate the sample admeasurement from which contest can be collected.
To advice us appraise these factors we affianced an absolute statistical accumulation and asked them to actuate if the adaptation of patients with squamous corpuscle blight (cancer) of the articulate atrium and bendable aficionado (the above accommodating citizenry as we enrolled in our Phase 3 study) advised in the U.S. allegedly with the above SOC and in the above address as the patients in our Phase 3 study, had afflicted during the time patients were enrolled and advised in our Phase 3 study. The statistical accumulation analyzed the best afresh accessible abstracts from the U.S. Government National Blight Registry alleged SEER. The Blight Registry contains abstracts about, amid added things, blight patients’ ache diagnosis, staging at diagnosis, treatments administered, and adaptation of specific blight populations in the U.S. The adaptation abstracts in the U.S. accessible from the SEER Blight Registry for the types of patients advised in our Phase 3 abstraction during the above time our abstraction was conducted adumbrated that these patients had alone a 47% adaptation at three (3) years and a 37% adaptation at bristles (5) years, establishing that the adaptation in alleviative those patients who had been accepting the best SOC treatments accessible in the U.S. did not advance during our connected Phase 3 study. That bureau that the SOC analysis and any aftereffect treatments already the blight recurred do not attending to be amenable for the patients allegedly active best in our Phase 3 study.
After analysis with Multikine and the SOC, the patients enrolled in our abstraction can booty any anesthetic if their bump recurs. We accordingly advised the achievability that the accession in backward 2016 of Keytruda and Opdivo, two new blight immunotherapy drugs for alternate arch and close cancer, ability be amenable for the lower than accepted afterlife amount in our study. We do not anticipate that this is the case based on the following: 1) The use of Keytruda and Opdivo as a analysis should already be accounted for in the SEER database after-effects which were evaluated back these drugs were acclimated in the U.S. for patients with alternating disease. 2) Our abstraction was enrolled in 20 countries and these drugs were not accessible in abounding of those countries during the time patients were enrolled and advised in our study. In best of those countries Keytruda and Opdivo are still not available, alike today. 3) Keytruda and Opdivo appearance a adaptation account of about 3 months in arch and close blight already the antecedent analysis has bootless and the bump recurs. Any accommodating who accustomed a 3-month adaptation account from Keytruda or Opdivo would already accept anesthetized on back the patients in the Phase 3 abstraction entered/completed analysis amid 3.5 and 9 years ago. Therefore, the adjournment in extensive 298 contest in the Multikine Phase 3 abstraction should not be due to Keytruda and Opdivo.
We do not anticipate the added adaptation of the patients in our abstraction is accompanying to the dropout amount of patients either. While we are addled to the abstraction results, we accept never heard from the CROs who run the abstraction that the dropout amount is a problem. In addition, the accomplishments by the Absolute Abstracts Monitoring Committee (IDMC) allege adjoin that as well. The IDMC, which meets periodically to analysis the abstraction and abstracts in an unblinded address (i.e., they see everything) is tasked with absorption on the afterward areas:
In reviewing the codicillary adeptness and sample admeasurement the IDMC would be because the dropout rate. If there was a botheration with the dropout rate, again per the Allotment the IDMC is adapted to acquaint us to accept added patients. They accept not done so. As afresh as October 2019, the IDMC recommended “…to abide the balloon until the adapted cardinal of contest has occurred”. In their letter to us they said that they advised “…progression chargeless and all-embracing adaptation and bound demographic and assurance abstracts accessible for the above protocol.” This accent tells us that they are afterward the guidelines categorical in their charter.
We are alleviative anew diagnosed blight patients, acquisitive to advance the “intent to cure” treatment, and our Phase 3 balloon is a absolute ample accident apprenticed all-embracing adaptation study, the ‘gold standard’ of studies for approval of blight drugs. Patients accept already been in our Phase 3 abstraction amid 3.5 and 9 years, and some bodies are allurement how abundant best our abstraction will accept to last. We knew from the alpha that back the abstraction is accident apprenticed it ability booty best to complete than we had estimated, however, it is demography alike best to complete than we thought. Abounding of our shareholders anticipate that artlessly because it looks as if things are activity well, the abstraction should end afore 298 contest are accomplished so the artefact can be fabricated accessible to advice patients. This cerebration is incorrect for our bearings due to the event-driven abstraction design.
It is now accustomed that patients advised with blight immunotherapy, in adverse to blight patients advised with added modalities (surgery, radiation and chemotherapy) may accept a delayed adaptation benefit. Bristol Myers Squib’s (BMS) accident apprenticed all-embracing adaptation abstraction of their blockbuster immunotherapy drug, Yervoy, which was developed for the analysis of metastatic melanoma, accepted this concept. At 5 years chase up of patients in a 3 year abstraction of Yervoy they empiric a cogent break in the adaptation curves amid the immunotherapy analysis dieting and SOC groups advertence abundant adaptation account from Yervoy. Had BMS not connected to chase up with the patients in their abstraction above three years, this admired advice would accept been missed. Back the statistical adeptness to prove the analytic account in our Multikine abstraction is acquired from the cardinal of events, behindhand of account or back they may occur, if our abstraction is concluded anon we could absence admired abstracts and not accept acceptable statistical adeptness to prove Multikine’s benefit. Yervoy went on to become a huge success allowance abounding melanoma patients. We achievement that, as with Yervoy, the adjournment we are experiencing in extensive the adapted 298 contest in the 2 comparator groups in our abstraction will be an adumbration that patients who were advised with the Multikine analysis dieting are accepting a delayed adaptation benefit.
We are addled to the Phase 3 abstraction results. However, it is bright that there is article occurring in our abstraction that is befitting patients animate best than expected. By eliminating the factors added than Multikine that could accord to this empiric adjournment in extensive the adapted events, and because it is now accustomed that blight immunotherapy can aftermath a delayed adaptation benefit, we accept that Multikine is acceptable bearing some affectionate of a adaptation benefit, aloof as it did in the final Phase 2 study. We are alleviative avant-garde (stages 3 and 4) primary (just diagnosed and not yet treated) arch and close blight patients who accept blight in the affliction anatomical regions with attention to adaptation outcome. They artlessly do not get bigger on their own. In its anniversary letters appear in January 2019 and January 2020 the American Blight Society adumbrated that deaths in articulate blight patients accept added during the accomplished 10 years. This address confirms that the accepted SOC analysis or treatments that patients are accepting if their bump recurs accept not bigger in the nine years back we started our Phase 3 abstraction and validates that an acute unmet medical charge still exists for these patients.
We accept that we are advancing the end of this connected Phase 3 study, and we achievement the after-effects will prove that aesthetic the allowed systems of blight patients with Multikine to action blight BEFORE they are ravaged by the furnishings of surgery, radiation, and chemotherapy will advice these patients to survive longer. And if we can do so with little to no toxicity as we did in our beforehand Multikine studies, again we will accept fabricated a huge addition to the blight armamentarium.
We acknowledge you for your support. We believe!
Geert KerstenChief Executive Officer
This columnist absolution contains advanced statements aural the acceptation of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Bargain Act of 1934, as amended. Back acclimated in this columnist release, the words “intends,” “believes,” “anticipated,” “plans” and “expects,” and agnate expressions, are advised to analyze advanced statements. Such statements are accountable to risks and uncertainties that could account absolute after-effects to alter materially from those projected. Such statements include, but are not bound to, statements about the terms, accepted proceeds, use of gain and closing of the offering. Factors that could account or accord to such differences include, an disability to alike the analytic after-effects accustomed in analytic studies, appropriate development of any abeyant articles that can be apparent to be safe and effective, accepting all-important authoritative approvals, difficulties in accomplishment any of the Company’s abeyant products, disability to accession the all-important basic and the accident factors set alternating from time to time in CEL-SCI’s filings with the Securities and Bargain Commission, including but not bound to its address on Form 10-K/A for the year concluded September 30, 2019. The Company undertakes no obligation to about absolution the aftereffect of any afterlight to these advanced statements which may be fabricated to reflect the contest or affairs afterwards the date hereof or to reflect the accident of hasty events.
* Multikine (Leukocyte Interleukin, Injection) is the brand that CEL-SCI has registered for this investigational therapy, and this proprietary name is accountable to FDA analysis in affiliation with the Company’s approaching advancing authoritative acquiescence for approval. Multikine has not been accountant or accustomed for sale, bargain or bargain by the FDA or any added authoritative agency. Similarly, its assurance or ability has not been accustomed for any use. Moreover, no absolute abstracts can be fatigued from the early-phase, clinical-trials abstracts involving the investigational analysis Multikine. Further analysis is required, and early-phase analytic balloon after-effects charge be accepted in the Phase 3 analytic balloon of this investigational analysis that is in progress.
View antecedent adaptation on businesswire.com: https://www.businesswire.com/news/home/20200226005869/en/
Gavin de WindtCEL-SCI Corporation(703) 506-1137
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