SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (date of earliest event reported): July 24, 2001
CEL-SCI CORPORATION
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(Exact name of Registrant as specified in its charter)
Colorado 0-11503 84-0916344
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(State or other jurisdiction (Commission File No.) (IRS Employer
of incorporation) Identification No.)
8229 Boone Blvd. #802
Vienna, VA 22182
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(Address of principal executive offices, including Zip Code)
Registrant's telephone number, including area code: (703) 506-9460
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N/A
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(Former name or former address if changed since last report)
Item 5. Other Events and Regulation FD Disclosure
CEL-SCI Corporation updated the progress of an ongoing clinical trial of
its proprietary investigational therapy, Multikine(TM) at the Institute of Human
Virology (IHV) at the University of Maryland Biotechnology Institute and the
University of Maryland, Baltimore.
The focus of this study is HIV-infected women with Human Papilloma Virus
(HPV) induced cervical dysplasia, the precursor stage before the development of
cervical cancer. Cervical cancer is the second leading cause of cancer death in
women worldwide. This patient population was chosen because of the high
morbidity/morality and low success rate of current surgical therapies. Since HIV
infection results in immune suppression, HPV-induced cervical dysplasia follows
a more malignant and aggressive course of disease in such women. Co-infection
with HPV is common in HIV-positive women and cervical cancer is considered and
AIDS defining illness.
HPV infection is also a leading health problem in non HIV-infected
American college age women. A large concern among women who have HPV-induced
cervical dysplasia is that the repeated surgical procedures will lead to a
hysterectomy and the inability to bear children.
The study, which started in May 2001, is designed to enroll up to a total
of 15 women at three dosage levels. As of August 2, 2001, seven patients were
enrolled in the study. While no patients have completed the study, the results
have been uniformly so encouraging that CEL-SCI has decided that, barring some
unforeseen circumstances, it will give the highest priority to clinical trials
in women with HPV-induced cervical dysplasia. The study investigators are
planning to present detailed interim results of this trial before the end of
this year.
With regard to HPV-induced cervical dysplasia, CEL-SCI is planning to meet
with the Food and Drug Administration (FDA) in the fall to determine the best
way to proceed. Given the great unmet medical need in HPV-induced cervical
dysplasia, CEL-SCI is hopeful that its meetings with FDA will lead to the
initiation of a clinical trial in patients with HPV-induced cervical dysplasia
next year, potentially under fast track designation.
Multikine is a mixture of immune system regulators known as cytokines and
chemokines at near physiologic doses. One of the cytokines, Interleukin-2, is
widely used to treat cancer. According to Dr. Eyal Talor, Senior Vice President
of Research and Manufacturing at CEL-SCI, Multikine has been tested in more than
140 cancer patients and in 14 AIDS patients, to date, with only minimal side
effects.
CEL-SCI Corporation is developing new immune system based treatments for
cancer and infectious diseases. CEL-SCI has operations in Vienna, Virginia and
Baltimore, Maryland.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Date: August 2, 2001
CEL-SCI CORPORATION
By: /s/ Geert R. Kersten
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Geert R. Kersten