CEL-SCI Corporation Releases Letter to Shareholders
VIENNA, Va., May 15 /PRNewswire/ -- The following letter is being mailed today from CEL-SCI Corporation (Amex: CVM; Berlin:LSR) to its shareholders.
We wish to take this opportunity to update you on some recent CEL-SCI developments. The exciting results from our clinical studies with our cancer product, Multikine(TM), are causing us to move full steam ahead to expand our very promising findings. The willingness of our European investigators to start a new round of Multikine studies in head and neck cancer patients, in which surgery will be delayed by an additional 1 to 2 weeks, indicates increasing confidence in the Multikine treatment.
Multikine:
Our focus on Multikine as a cancer treatment continues to increase because of the exciting results we are seeing in our human studies. Between 50% and 100% of the cancer patients in our studies have had tumor reductions, depending on the dose, frequency and route of administration.
Since the beginning of this year, we have announced results from two clinical trials (58 patients) with Multikine in the treatment of head and neck cancer. We also have seen data from two other clinical studies (an additional 46 patients), which we are currently evaluating. The message we have received from the clinical investigators is the following: Multikine is safe and induces anti-tumor responses. The number of patients who show tumor reductions and the magnitude of these reductions vary with the dose given, the frequency of the administration and the route of administration. The current goal is to find the best way to administer Multikine before we enter Phase III clinical studies, planned for 2001.
In some of the completed studies the planned date for the surgery was delayed, either because the patient did not want to undergo the operation or because the hospital had a nurses' strike. The doctors observed at that time that the tumors often continued to regress during this delay. To us, who have a background in immunology, this made perfect sense since it takes a while to develop an immune response and it takes even longer for the immune response to work its "magic." To these surgeons, however, these were important observations without which they would not have delayed the surgery further.
These observations led us to propose delaying surgery by up to 6 weeks, instead of the usual 3-4 weeks, in new European studies. The North American studies could not be changed because the regulatory filings had already been made. All of our European investigators enthusiastically endorsed this idea and welcomed continued participation in the studies.
Our final decision on the best way to administer Multikine will be based on both tumor reduction and pathology (analysis of tissue from the tumor). Preliminary findings in some of our studies indicate that, even though there appeared to be no change in tumor size, in some patients the "tumor" tissue no longer contained tumor cells. Obviously, we are spending a lot of time investigating and confirming this very important observation.
In summary, we believe that we have found what is likely to be the best treatment approach with Multikine in head and neck cancer. To confirm this, we are currently preparing to start several new studies involving 60 patients in Canada and Europe. In addition, we plan to expand into other tumor types. We believe that Multikine should work in many solid tumors.
AIDS Vaccine:
We have recently offered the government of the Republic of South Africa a free license to our AIDS vaccine in exchange for access to study results for any eventual marketing of the vaccine by the Company in other countries. We have done so because 1,500 people become infected with HIV every day in South Africa alone. Yet, for the most part, ideas from the West are rejected and therefore the problem continues to escalate. Our vaccine is the only AIDS vaccine designed for South Africa that has been tested in humans. Therefore, we believe that it is about 4-5 years ahead of any other AIDS vaccine for that region.
We feel that the only way to help this part of the world is to make the government our partner. We are hopeful that the government of South Africa will accept our offer. However, given the fact that President Mbeki of South Africa has convened a commission to investigate whether HIV is actually the cause of AIDS, the government may not accept our offer.
We thank you again for your support. Our goal is to build a viable and successful Company while, at the same time, making a significant difference in people's lives. We are confident that we are on the right path to reaching this goal.
Sincerely,
Maximilian de Clara
Geert Kersten
President, Chief Executive Officer |
