Finally we have some clear word from management ... tho NOT buyout offer ... still, very encouragin' on Multikine:
CEL-SCI Corporation Sends Letter to Shareholders
VIENNA, Va., Sept. 20 /PRNewswire/ -- Maximilian de Clara, President and Chairman of the Board and Geert Kersten, Esq., Chief Executive Officer of CEL- SCI Corporation (Amex: HIV; Berlin Stock Exchange: LSR), sent the following letter, dated September, 1999 to the shareholders:
Dear Fellow Shareholder:
The past few months have been both exciting and frustrating, because while we are getting positive reports from our Multikine(TM) cancer studies, we cannot share them with you until they are completed, checked and then re- checked. We can, however, tell you that we are designing a new manufacturing facility for Multikine in anticipation of a pivotal clinical trial expected to start in the second half of 2000. This trial would hopefully support accelerated approval to market Multikine.
Whenever we write a letter to our fellow shareholders, we have to decide which of the many developments to cover, in what kind of detail, and at what level of sophistication. We are constantly balancing the requirements of the SEC against those of the FDA, the wishes of the shareholders to publicize good news against the requests of the doctors not to do so because that might lead to demands from very sick cancer patients for Multikine when they cannot have access to it. There are still many other considerations that we must deal with on a daily basis. Please be assured that we seek to find the best balance for keeping you informed while at the same time taking into consideration the concerns of the medical community, FDA and SEC.
This letter will attempt to address many of the shareholder questions on Multikine that we have received in the last few months. Our other products will be covered in future communications. For simplicity's sake, we have elected the question and answer format:
What is the main focus of CEL-SCI's work?
Our immune booster drug, Multikine, for the treatment of cancer, is our main product. We are developing it first for head and neck cancer, which is No. 6 in cancer incidence around the world, then hopefully for prostate and breast cancer. There may, however, also be valuable uses for Multikine in rebuilding the immune system of AIDS patients.
What are the competing products to Multikine?
We do not see other cancer products as competitors, but as potential collaborators. Cancer is such a complicated disease that a combination of different treatments is often the better way to deal with it properly. We believe that a Multikine-induced, anti-cancer immune response may very well improve the benefit of solid cancer treatments already on the market or in development.
How do you plan to develop Multikine?
Multikine is currently in five head and neck cancer studies in six countries and one prostate cancer study in the U.S. Additional studies are being set up.
Most cancer drugs (about 95%) are developed for patients who have failed previous therapies. While we have seen promising results in those patients, it does not seem optimal to use an immune booster, such as Multikine, in cancer patients whose immune system is already severely damaged by earlier cancer therapy. Also, to have a big impact on cancer survival, you should intervene early and stop the patient from ever progressing to the terminal stage. The combination of these two factors has led us to use Multikine in advanced, not yet treated patients. In head and neck cancer, the primary treatment usually is surgery, sometimes followed by radiation. Yet even with surgery, there is a very high recurrence rate which usually leads to death. Our goal is to reduce the recurrence rate and therefore increase survival by treating each patient with Multikine for a period of two weeks prior to surgery.
How are head & neck cancer patients treated with Multikine?
Multikine is given by local injection 3 to 5 times per week for two weeks prior to surgery or radiation. In order to enhance the anti-tumor activity of Multikine, patients are pretreated with cyclophosphamide, a drug commonly used in the treatment of cancer. In addition, patients take indomethacin for 18 days. In some protocols they also receive zinc and multivitamin supplements.
Cyclophosphamide, given at half the effective cancer treatment dose, and indomethacin are given to enhance the anti-tumor effects of Multikine. Cyclophosphamide reduces the effects of T suppressor cells and indomethacin inhibits macrophage suppression, theoretically overcoming the tumor defense mechanism. From here on, when we talk about treatment with Multikine in head and neck cancer, we mean the treatment protocol outlined above.
What can Multikine do in just 2 weeks?
Surgery is the proven therapy, while Multikine is not yet proven. Therefore, two weeks of Multikine treatment is the compromise our collaborators have agreed to. Once Multikine is proven to work, doctors may use it for longer times.
The primary problem for the head and neck cancer surgeon is not the actual tumor which can be felt or seen, and therefore cut out, but the tumor cell "islands" which are known to extend up to 2 cm beyond the tumor, but cannot be felt or seen. If the surgeon misses some of those tiny cells, the tumor will recur, making the patient basically incurable.
The primary goal of the 2-week treatment with Multikine is not to eliminate or even reduce the tumor, as it will be cut out anyway. Our goal is to destroy the tumor cells outside of the tumor itself. Injections with Multikine are given around the tumor, not into the tumor. We view tumor reductions merely as an indicator of a good anti-tumor immune response.
What can you tell us about your results so far?
We have seen very encouraging data from all of our human studies, with minimal side effects. About 80 patients have been treated in the current Multikine cancer studies. Only one study, however, has been reported at a scientific conference, which allows us to disclose only these results to shareholders. This study, conducted in Israel, involved ten head and neck cancer patients scheduled for surgery. They received two weeks of Multikine treatment prior to surgery. All ten patients had tumor reductions prior to surgery within a short time period. Three patients out of ten had tumor reductions exceeding 50% and one patient, who had a tumor of 7 cm (nearly 3 inches) diameter, had a complete clinical response with no measurable tumor left. Two patients refused surgery because they were satisfied with their condition after the treatment. We will report on their current condition in a scientific publication presently being prepared.
What is the proposed mechanism of action of Multikine?
We believe that Multikine's anti-cancer activity is due to a 3-pronged attack against the tumor. Some of the cytokines included in Multikine are known to attack the tumor cells directly. Others will work indirectly as messengers to induce chemotactic and/or lymphoproliferative immune responses to kill the tumor cells. Theoretically, these responses should lead to a memory immune response which should lower the rate of tumor recurrence in the future, thereby increasing survival.
Earlier you had mentioned AIDS as a possible application for Multikine? Please explain!
In the U.S. and Europe, early diagnosis and intervention with antiretroviral therapies have extended the life expectancy and improved the quality of life for people infected with HIV. As a result, a growing patient population has emerged that is comprised of HIV-infected individuals with markedly compromised immune systems. Although these individuals suffer from recurrent infections and fevers, they are relatively healthy. Therefore, in addition to antiretroviral treatment regimes, therapies aimed at boosting the cellular arm of the immune system are needed for these patients. Multikine contains certain cytokines and chemokines thought to be beneficial to the immune system of AIDS patients.
For this reason, we have conducted a 14 patient, 2-dosage Multikine safety study with HIV infected patients. We expect to report on the results of this study this fall.
E-mail list:
Sometimes there are developments in the press that we might want to comment on to our shareholders only. We could do so by mailing out letters such as this one, but doing so would be much too slow and expensive. Therefore, we invite you to send to us your e-mail address by mail, fax or e- mail to ddavis@cel-sci.com so that we may include you on our e-mail list.
Together we are trying to make an important difference in the lives of many cancer patients. The progress is never fast, but if we are right, we will all be very proud of our participation in CEL-SCI.
With best regards,
sincerely,
Maximilian de Clara Geert Kersten
President & Chairman of the Board Chief Executive Officer
When used in this report, the words "intends," "believes," "anticipated" and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinic results demonstrated in preclinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10-K for the year ended September 30, 1998. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
SOURCE CEL-SCI Corporation
CO: CEL-SCI Corporation
ST: Virginia
IN: MTC BIO
SU:
09/20/1999 16:00 EDT prnewswire.com |
