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Cel-Sci Corporation

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This is an old revision of this page, as edited by DGG (talk | contribs) at 03:54, 7 April 2020 (Submitting (AFCH 0.9.1)). The present address (URL) is a permanent link to this revision, which may differ significantly from the current revision.

  • Comment: It is not a company that " treats cancer, autoimmune and infectious diseases " It is a company that hopes to produce substances that may eventually get approved in order to treat them.
    SO far, it has one product in phase III, and one only. DGG ( talk ) 10:39, 24 March 2020 (UTC)

Cel-Sci Corporation (NYSE American: CVM), is a biotechnology company that is testing drugs for the treatment of cancer, autoimmune and infectious diseases through the research and development of immunotherapy products. It's product Multikine is currently in Phase III of Clinical Trials with the Federal Drug Administration (FDA).

Cel-Sci's main product is the drug Multikine, an immunotherapeutic agent designed and expected 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] 928 patients were enrolled in head and neck cancer trial at that time.[1]

History

Cel-Sci Corporation was founded in 1983 in Germany by Maximilian de Clara of Switzerland, who was also the president of the company until 2016 when he resigned.[6]  The company went public in the year of its founding, 1983. [7]

The company's United States research and development operations were based in Baltimore, Maryland in the mid-1990s.[8]

NYT reported that Cel-Sci received an unsolicited cash offer of $124 million In 1999 from an unidentified person in Argentina.[9]

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.[8]

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 and FDA 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.[10][11]

Other products

LEAPS (Ligand Epitope Antigen Presentation System) technology, a therapeutic vaccine for rheumatoid arthritis.[12]

HGP-30 is also the product being tested to find if it is an effective treatment against the AIDS virus.[13][14][15]

References

  1. ^ a b "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 19 March 2020.{{cite web}}: CS1 maint: url-status (link)
  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.{{cite web}}: CS1 maint: url-status (link)
  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 11 March 2020.{{cite web}}: CS1 maint: url-status (link)
  4. ^ "Cel-Sci Receives Orphan Drug Designation for Its Cancer Drug Multikine". WCG FDANews. WIRB-Copernicus Group. June 13, 2007. Retrieved 22 Feb 2020.{{cite web}}: CS1 maint: url-status (link)
  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).
  6. ^ "BRIEF-CEL-SCI announces resignation of its founder, Maximilian De Clara, for health reasons" (Brief). Reuters. September 6, 2016. Retrieved 22 Feb 2020.{{cite news}}: CS1 maint: url-status (link)
  7. ^ "test approval sends aids drug company stocks higher". Newspapers.com. Retrieved 2020-03-20.
  8. ^ a b "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.{{cite news}}: CS1 maint: url-status (link)
  9. ^ "CEL-SCI Corporation". The New York Times. ISSN 0362-4331. Retrieved 2020-03-20.
  10. ^ Zacks Small Cap Research (October 16, 2018). "CVM: A New Solution in Head & Neck Cancer". Yahoo! Finance. Retrieved 22 Feb 2020.{{cite web}}: CS1 maint: url-status (link)
  11. ^ "BRIEF-FDA removes clinical hold on Cel-Sci head & neck cancer trial" (Brief). Reuters. August 14, 2017. Retrieved 19 March 2020.{{cite news}}: CS1 maint: url-status (link)
  12. ^ "New Vaccine in the Treatment of Rheumatoid Arthritis". BioSpectrum Asia. Singpore: MM ACTIV. July 9, 2019. Retrieved 11 March 2020.{{cite web}}: CS1 maint: url-status (link)
  13. ^ "HGP-30 AIDS VACCINE SAFE IN TRIAL". BioWorld. Clarivate. December 3, 1992. Retrieved 21 Feb 2020.{{cite web}}: CS1 maint: url-status (link)
  14. ^ "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 – via SpringerLink.
  15. ^ "Test approval sends 2 AIDS-drug companies' stock higher". The Desert Sun. Vol. 62, no. 186. Palm Springs, California: Gannett. Associated Press. March 9, 1990. p. C4 – via Newspapers.com.{{cite news}}: CS1 maint: url-status (link)