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CEL-SCI's Phase 3 Multikine                             Continues.                         Is It Time To Petition The FDA?

|About: CEL-SCI Corporation (CVM)
Summary

The Phase 3 Multikine Clinical Trial Continues to Await Its End Point.

Are Newly Diagnosed Patients With SCCHN being harmed?

Maybe It's Time to Petition the FDA for Immediate Approval of Multikine.

Readers are referred to my SA article entitled "Cel-Sci Corporation: This Phoenix Will Rise" published on October 2018 for a summary of Cel-Sci Corporation and its Multikine immunological therapy.

Patients, the medical community, and investors continue to wait for the end of Cel-Sci's Phase 3 trial using Multikine in squamous cell cancer of the head & neck (SCCHN). In March, 2019, Cel-Sci reported the study's IDMC (Independent Data Monitoring Committee) recommended to “continue the trial until the appropriate number of events has occurred”.

And we are still waiting.

Thought leaders and others I have communicated with have indicated the trial should have ended long ago. Therefore, one questions what is going on? Some have indicated that an improvement in the standard of care (SOC) over the years is keeping those treated with SOC alone living longer. However, recent data indicates that survival statistics have not changed over the years.(Cel-Sci Corporation Letter to Shareholders May 2019)

Another possibility is that Multikine is actually curing patients. Cel-Sci's Phase 3 trial is, after all, an "Intent to Cure" study. We have evidence of this potential. A scientific paper entitled "Report of a Clinical Trial in Twelve Patients with Head and Neck Cancer treated Intratumorally and Peritumorally with Multikine" was conducted in Israel in 2003. Twelve newly diagnosed patients underwent Multikine therapy prior to their SOC treatment (i.e. surgery). Importantly, 2 of these 12 patients refused surgery after receiving Multikine but consented to a biopsy. One of these patients was alive and asymptomatic with histological tumor regression after 30 months when the study was published. The second patient refusing surgery was found to have a reduction in tumor size and histological improvement but was then lost to follow up. Of the remaining patients who received both Multikine and surgery, the clinical follow-up was similar to other Multikine plus SOC trials. (Feinmesser et. al. Arch Otolaryngol Head Neck Surg/Vol 129 Aug 2003)

If Multikine is curing or significantly increasing the survival of patients, we may be waiting a long, long time for the 298th patient to die.

Additionally, as a physician, I am concerned about patients currently diagnosed with SCCHN. If Multikine is curing patients or extending their longevity significantly compared to the current SOC, then I believe these newly diagnosed patients are potentially being deprived of therapy with Multikine.

Maybe it's time to petition the FDA to approve the drug immediately because of extraordinary benefit. The FDA has a history of discontinuing trials early for this reason. (Trottal et. al. Annals of Oncology 19: 1347–1353, 2008).

To assist those interested in contacting the division of the FDA involved in Multikine, the address follows:

Food and Drug AdministrationCenter for Biologics Evaluation and Research (CBER). 10903 New Hampshire Avenue. Silver Spring, MD 20993-0002

Additionally, to assist those desiring to contact US legislators concerning Multikine, I have identified a Federal Caucus termed "The Congressional Caucus on the Deadliest Cancers" This caucus, which began in 2017, is comprised of 132 bipartisan legislators to date. The caucus raises awareness about the deadliest forms of cancer, defined as those with a five-year survival rate below 50 percent and advocates for measures to increase survival rates for these cancers.

Members of Congress from both parties and both the House and the Senate have joined the caucus to show their support and commitment to addressing the threat of these deadly cancers. Below is a list of legislators who have joined the caucus.

Co-Chairs: Rep. Anna Eshoo (D-CA)Rep. Joe Kennedy (D-MA)Rep. Leonard Lance (R-NJ)Rep. Dave Reichert (R-WA)

Senate: Sen. Maria Cantwell (D-WA)Sen. Joni Ernst (R-IA)Sen. Chuck Grassley (R-IA)Sen. Heidi Heitkamp (D-ND)Sen. Angus King (I-ME)Sen. Joe Manchin (D-WV)Sen. Shelley Moore Capito (R-WV)Sen. Jerry Moran (R-KS)Sen. Gary Peters (D-MI)Sen. James Risch (R-ID)Sen. Pat Roberts (R-KS)Sen. Mike Rounds (R-SD)Sen. Charles Schumer (D-NY)Sen. Jeanne Shaheen (D-NH)Sen. Debbie Stabenow (D-MI)Sen. Jon Tester (D-MT)Sen. Sheldon Whitehouse (D-RI)

House: Rep. Joe Barton (R-TX)Rep. Don Beyer (D-VA)Rep. Gus Bilirakis (R-FL)Rep. Mike Bishop (R-MI)Rep. Rod Blum (R-IA)Rep. Earl Blumenauer (D-OR)Rep. Michael Burgess (R-TX)Rep. Matt Cartwright (D-PA)Rep. David Cicilline (D-RI)Rep. Emanuel Cleaver (D-MO)Rep. Mike Coffman (R-CO)Rep. Steve Cohen (D-TN)Rep. Barbara Comstock (R-VA)Rep. Gerry Connolly (D-VA)Rep. Lou Correa (D-CA)Rep. Ryan Costello (R-PA)Rep. Joe Courtney (D-CT)Rep. Susan Davis (D-CA)Rep. Rodney Davis (R-IL)Rep. Peter DeFazio (D-OR)Rep. Rosa DeLauro (D-CT)Rep. Mark DeSaulnier (D-CA)Rep. Debbie Dingell (D-MI)Rep. Lloyd Doggett (D-TX)Rep. Mike Doyle (D-PA)Rep. Eliot Engel (D-NY)Rep. Brian Fitzpatrick (R-PA)Rep. Bill Foster (D-IL)Rep. Brett Guthrie (R-KY)Rep. Gregg Harper (R-MS)Rep. Dennis Heck (D-WA)

Rep. Jim Himes (D-CT)Rep. Pramila Jayapal (D-WA)Rep. Hank Johnson (D-GA)Rep. David Joyce (R-OH)Rep. William Keating (D-MA)Rep. Ro Khanna (D-CA)Rep. Dan Kildee (D-MI)Rep. Peter King (R-NY)Rep. Adam Kinzinger (R-IL)Rep. James Langevin (D-RI)Rep. Ted Lieu (D-CA)Rep. Dave Loebsack (D-IA)Rep. Zoe Lofgren (D-CA)Rep. Alan Lowenthal (D-CA)Rep. Blaine Luetkemeyer (R-MO)Rep. Michelle Lujan Grisman (D-NM)Rep. Stephen Lynch (D-MA)Rep. Tom MacArthur (R-NJ)Rep. Roger Marshall (R-KS)Rep. Doris Matsui (D-CA)Rep. Betty McCollum (D-MN)Rep. James McGovern (D-MA)Rep. David McKinley (R-WV)Rep. Seth Moulton (D-MA)Rep. Rick Nolan (D-MN)Rep. Donald Payne (D-NJ)Rep. Chellie Pingree (D-ME)Rep. Robert Pittinger (R-NC)Rep. Mark Pocan (D-WI)Rep. Jared Polis (D-CO)Rep. David Price (D-NC)Rep. Jamie Raskin (D-MD)Rep. Ben Ray Lujan (D-NM)Rep. Kathleen Rice (D-NY)Rep. Keith Rothfus (R-PA)Rep. Bobby Rush (D-IL)Rep. Linda Sanchez (D-CA)Rep. Adam Schiff (D-CA)Rep. Pete Sessions (R-TX)Rep. Brad Sherman (D-CA)Rep. Bill Shuster (R-PA)Rep. Steve Stivers (R-OH)Rep. Eric Swalwell (D-CA)Rep. Mark Takano (D-CA)Rep. Glenn Thompson (R-PA)Rep. Bennie Thompson (D-MS)Rep. Dina Titus (D-NV)Rep. Tim Walberg (R-MI)Rep. Greg Walden (R-OR)Rep. Tim Walz (D-MN)Rep. Bonnie Watson Coleman (D-NJ)Rep. Peter Welch (D-VT)Rep. Frederica Wilson (D-FL)Rep. John Yarmuth (D-KY)Rep. Kevin Yoder (R-KS)Rep. David Young (R-IA).

Disclosure: I am/we are long CVM.