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CEL-SCI Corporation

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CEL-SCI Corporation
CVM
ISIN🆔
IndustryBiotechnology
Founded 📆1983
Founder 👔Maximilian de Clara
Area served 🗺️
Key people
Geert Kersten, CEO
Products 📟 Multikine, LEAPS, HGP-30
Members
Number of employees
🌐 Websitehttps://cel-sci.com/
📇 Address
📞 telephone

CEL-SCI Corporation (NYSE American: CVM), is a biotechnology company that treats cancer, autoimmune and infectious diseases through the research and development of immunotherapy products. CEL-SCI has operations in Vienna, Virginia and Baltimore, Maryland. It is currently in Phase III of Clinical Trials with the Federal Drug Administration (FDA).

Multikine[edit]

CEL-SCI's main product and existence have been based on the drug Multikine, an immunotherapeutic agent designed to fight cancer by stimulating the body's immune system. The therapeutic has also been referred to as Leukocyte Interleukin Injection (LI).[1] Multikine was in Phase II testing of patients with head and neck cancer in the early 2000s, in which it demonstrated tumor-reducing ability.[2][3] In January 2007, the US cleared the Phase 3 trial and Multikine was designated as an orphan drug by the FDA for the orphan population of neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.[4][5] CEL-SCI conducted a Phase III clinical trial of Multikine in head and neck cancer from 2010 to 2019, testing the effect of boosting the immune system before surgery, chemotherapy, and radiation because that is when the immune system is strongest.[1] At 928 patients enrolled, this was the largest head and neck cancer trial at the time.[1]

In August 2007 CEL-SCI build a 73,000 sqft manufacturing facility for Multikine located in the Baltimore area and took possession of the new facility in October 2008.[6]

Other therapeutics[edit]

LEAPS (Ligand Epitope Antigen Presentation System) technology, is another Cel-Sci product which is currently being developed as a therapeutic vaccine for rheumatoid arthritis and is supported by grants from the National Institutes of Health.[7]

HGP-30 is also the product being tested to find if it is an effective treatment against the AIDS virus.[8][9][10] Unlike most other AIDS treatments developed at the time, HGP-30 was wholly abiotic, containing no components of the AIDS virus.[11] HGP-30 was developed by Viral Technologies, a joint venture between CEL-SCI and Alpha 1 Biomedicals, and first entered human trials in 1990.[11]

History[edit]

CEL-SCI Corporation was founded in 1983 in Germany by Maximilian de Clara of Switzerland,[11] who was also the president of the company until 2016 when he resigned.[12] The company went public in the year of its founding, 1983.[11]

The company's United States research and development operations were based in Baltimore, Maryland in the mid-1990s.[13] Prior to this, in the early 1990s, they had a facility in Alexandria, Virginia.[11]

In 1997, CEL-SCI bought out a technology which enabled regulation of immune system responses that they had been licensing from the Dutch company Sittona.[13]

In 2018, CEL-SCI won a 4.5-year-long arbitration suit filed in October 2013 against CRO for breach of contract. The arbitrator awarded CEL-SCI $2.9 million in damages because the CRO was failed to enroll required number of patients over the period of 2 years that delayed clinical development of Multikine. Later, the arbitration resolution allowed CEL-SCI to focus and continue to the Phase III primary head and neck cancer study by lifting the FDA clinical hold imposed in August 2017.[14][15][16]

In 2019, an avid shareholder of CEL-SCI created the due diligence site KillCVMShorts.com which has infuriated the Shorts.[17]

CEL-SCI received an unsolicited cash offer of $124 million In 1999 from an unidentified person in Argentina, that caused the rise in shares. [18]

Reference[edit]

  1. 1.0 1.1 1.2 "Efficacy and Safety Study of Leukocyte Interleukin,Injection (LI) to Treat Cancer of the Oral Cavity - Full Text View - ClinicalTrials.gov". ClinicalTrials.gov. U.S. National Library of Medicine. October 1, 2019. Retrieved 22 Feb 2020. Unknown parameter |url-status= ignored (help)
  2. "Washington Techway, Cel-Sci CEO Geert Kersten". Live Online (Press conference transcript). Washington, D.C.: The Washington Post. May 30, 2001. Retrieved 22 Feb 2020. Unknown parameter |url-status= ignored (help)
  3. "A Phase III Study of the Effects of Multikine on Cancer of the Oral Ca". Research Summaries. London: NHS Health Research Authority. January 23, 2015. Retrieved 22 Feb 2020. Unknown parameter |url-status= ignored (help)
  4. "Cel-Sci Receives Orphan Drug Designation for Its Cancer Drug Multikine". WCG FDANews. WIRB-Copernicus Group. June 13, 2007. Retrieved 22 Feb 2020. Unknown parameter |url-status= ignored (help)
  5. Plunkett, Jack W., ed. (2007). Plunkett's Biotech and Genetics Industry Almanac 2008 : Biotech & Genetics Industry Market Research, Statistics, Trends & Leading Companies. Plunkett, Jack W. Houston, Texas: Plunkett Research Ltd. CEL-SCI CORPORATION. ISBN 978-1-59392-087-6. OCLC 154805775 – via Google Books (Preview). Search this book on
  6. "CEL-SCI Takes Delivery of New Manufacturing Facility" (Press release). CEL-SCI. October 9, 2008. Retrieved 22 Feb 2020 – via BioSpace.[self-published source]
  7. "New Vaccine in the Treatment of Rheumatoid Arthritis". BioSpectrum Asia. Singpore: MM ACTIV. July 9, 2019. Retrieved 22 Feb 2020. Unknown parameter |url-status= ignored (help)
  8. "A Promising Development Offers New Hope". Spotlight on Health. Lake Geneva Regional News. 123 (36). Lake Geneva, Wisconsin: Lake Geneva Printing & Publishing. NAPS. September 4, 1996. p. 70. Unknown parameter |url-status= ignored (help)
  9. "HGP-30 AIDS VACCINE SAFE IN TRIAL". BioWorld. Clarivate. December 3, 1992. Retrieved 21 Feb 2020. Unknown parameter |url-status= ignored (help)
  10. "HIV HGP-30W vaccine (Cel-Sci)". Drugs in R&D. 1 (6): 453–455. 1999. doi:10.2165/00126839-199901060-00007. ISSN 1174-5886. PMID 10566082.
  11. 11.0 11.1 11.2 11.3 11.4 "Test approval sends 2 AIDS-drug companies' stock higher". The Desert Sun. 62 (186). Palm Springs, California: Gannett. Associated Press. March 9, 1990. p. C4 – via Newspapers.com. Unknown parameter |url-status= ignored (help)
  12. "BRIEF-CEL-SCI announces resignation of its founder, Maximilian De Clara, for health reasons" (Brief). Reuters. September 6, 2016. Retrieved 22 Feb 2020. Unknown parameter |url-status= ignored (help)
  13. 13.0 13.1 "CEL-SCI buys rights to new technology". Business Digest. The Sun (Final ed.). Baltimore, Maryland: Times Mirror. March 18, 1997. p. 2C – via Newspapers.com. Unknown parameter |url-status= ignored (help)
  14. Zacks Small Cap Research (October 16, 2018). "CVM: A New Solution in Head & Neck Cancer". Yahoo! Finance. Retrieved 22 Feb 2020. Unknown parameter |url-status= ignored (help)
  15. Hale, Conor (July 10, 2018). "Cel-Sci wins 4.5-year-long arbitration case against CRO for breach of contract". FierceBiotech. Questex. Retrieved 22 Feb 2020. Unknown parameter |url-status= ignored (help)
  16. "BRIEF-FDA removes clinical hold on Cel-Sci head & neck cancer trial" (Brief). Reuters. August 14, 2017. Retrieved 22 Feb 2020. Unknown parameter |url-status= ignored (help)
  17. "Jim Cramer Gives CEL-SCI BUY". Killcvmshorts. Retrieved 22 Feb 2018. Unknown parameter |url-status= ignored (help)
  18. "CEL-SCI RECEIVES UNSOLICITED $124 MILLION BID". NYT. August 19, 1999. Retrieved 26 Feb 2020. Unknown parameter |url-status= ignored (help)


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