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AIDS Vaccine Optimism
Celebrated by Corporation

CEL-SCI Shareholder Letter
Points to Hopeful Trials

Multikine Showing Promise
for both Cancer & AIDS Patients

Compiled by GayToday

aidsresearch.gif - 11.97 K Vienna, Virginia– The following letter was recently mailed from CEL-SCI Corporation (Amex: HIV; Berlin Stock Exchange: LSR) to its shareholders.

The shareholders' letter was signed by Maximilian de Clara, President & Chairman of the Board, and Geert Kersten, Chief Executive Officer. Though it closes warning of possibilities of research failures, the letter is nevertheless telling for the optimism CEL-SCI projects. The letter says:
We are pleased to report that CEL-SCI has achieved almost all of its goals set for 1998. This was accomplished despite a very difficult financial market in 1998 for small biopharmaceutical companies such as ours.

We enter 1999 with great confidence because, based on our promising results in cancer and AIDS, we have started phase II human clinical trials in six countries on three continents. By the end of 1999, we expect to have clinical data from over 150 new patients in these two major diseases.

Over the years, through selective acquisitions, we have built a very broad pipeline of potentially breakthrough products in the field of immunotherapy. This strategy allows us to diversify our risk and develop a broad range of drugs through phase II trials without significant capital and R&D expenditures.

The following explains the strategy for the development of our cancer drug Multikine(TM), our "platform" technology L.E.A.P.S.(TM), as well as our AIDS vaccine HGP-30W which is being developed by our wholly-owned subsidiary, Viral Technologies, Inc.

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Strategy for Multikine:

Since Multikine activates and boosts the local immune response, it is targeted to treat advanced, previously untreated cancer patients whose immune systems have not yet been destroyed by conventional therapies (e.g., radiation).

The Company's initial focus is on head and neck cancer, the sixth most frequently occurring cancer, because there has only been very limited progress in its treatment during the past decades.

tumor1.jpg - 7.04 K A tumor before treatment with Multikine
Photo: CEL-SCI
Multikine is not tumor specific. Therefore, if Multikine is effective in difficult head and neck cancer cases, it may also work in many other cancers and perhaps even other diseases as well. For that reason, we are also testing Multikine in prostate cancer and AIDS patients.

After establishing the safety of Multikine in our U.S./Canadian study in cancer patients who have failed previous therapies, we received highly encouraging results from our first human study with ten advanced, previously untreated head and neck cancer patients.

All ten patients in this study had marked tumor reductions after only two weeks of treatment. Three patients had reductions exceeding 50% and one had a complete clinical tumor response. These data were very positive, particularly since the patients were treated for only two weeks.

Unlike other cancer drugs which have significant and often severe side effects, Multikine has shown only minimal side effects. In fact, many Multikine patients reported that their pain was reduced and that they felt better.

The vast majority of head and neck cancer patients receive surgery as first-line (initial) treatment, sometimes followed by radiation. Yet, even after such treatments which have significant side effects, about 50% of these patients experience tumor recurrence. When that happens, their prognosis is typically poor and they undergo more surgery, radiation and/or chemotherapy. tumor2.jpg - 5.66 K The same tumor after 45 days of Multikine treatment
Photo: CEL-SCI

Where Does Multikine Fit In?

We intend to make Multikine a part of first-line therapy to significantly increase the success rate (cure rate) of those patients. Most of our studies will be conducted in patients with advanced, previously untreated head and neck cancer with Multikine given before surgery and/or radiation. Multikine therapy is given during the first two weeks, with surgery or radiation to follow after the third week.

We believe that the success of Multikine will ultimately be measured by its impact on the overall tumor recurrence rate in these patients and its benefit on patient quality of life.

Our medical advisers believe that inducing an immune response directed against tumor cells prior to surgery will result in higher cure rates. We are presently conducting additional studies in several countries to determine the best dosage.

Strategy for L.E.A.P.S. ™

Our L.E.A.P.S. "platform" technology places CEL-SCI in the forefront of leading-edge immunotherapies that may ultimately rewrite today's medical textbooks. This revolution has to do with ways of inducing the appropriate type of immune response to better eliminate or control diseases.

Currently, our primary goal is to test L.E.A.P.S. products in a variety of animal models.

A secondary goal is to explain the mechanism which confers protection against the disease. L.E.A.P.S. compounds have already shown protection against herpes simplex virus challenge in animals, and we are making good progress (not yet published) in explaining the mechanism of action.

We hope to take our first L.E.A.P.S. product into human testing in the first quarter of the year 2000. Our goal is to develop L.E.A.P.S. using funding from government grants and collaborations in order to minimize the Company's financial risk.

  • Herpes Simplex – In the summer of 1998, we announced a National Institutes of Health (NIH) grant for the development of a L.E.A.P.S. herpes simplex vaccine.

  • Malaria – In the summer of 1998, the U.S. Naval Medical Research Institute extended its 1996 agreement with CEL-SCI for the development of a malaria vaccine.

  • HIV – In the fall of 1998, the NIH awarded a follow-on grant to the University of Nebraska to test different HIV vaccine technologies, including several HGP-30 related L.E.A.P.S. formulations.

  • Tuberculosis – In January 1999, the State of Maryland funded a grant for the development of a tuberculosis vaccine, using L.E.A.P.S. and DNA technology.

  • Cancer – We also are continuing our L.E.A.P.S. agreement with the National Cancer Institute to show the potential of therapeutic vaccines against breast and prostate cancer.

    All of these collaborations are proceeding well. We will keep you informed of their progress through scientific presentations, publications and press releases.

    Strategy for HGP-30W AIDS Vaccine:

    celsilogo.gif - 3.88 K AIDS is devastating many countries around the world, with 16,000 new cases reported each day. By the year 2000 there are expected to be 40 million people infected with the AIDS virus.

    Ninety percent of new HIV infections occur in Africa and Asia. China and India are thought to be in the early stages of a new AIDS explosion. However, most of the AIDS vaccine research is being conducted on HIV subtype B which is prevalent in the U.S. and Europe, while different subtypes (A, C, D and E) predominate in Africa and Asia.

    Hence, there is an urgent need for an effective AIDS vaccine in the developing world.

    Some time ago CEL-SCI Corporation decided to focus its efforts on the developing world where the need is greatest. Our scientific team modified our AIDS vaccine to work best with the subtypes found in developing countries while preserving its potential to work in developed countries.

    We are now ready to test our AIDS vaccine in Africa to help those who need it the most. In the meantime, we have been conducting a phase II clinical study of the HGP-30W vaccine in Europe.

    The results of this study will be available later this year.

    Over 90 volunteers have been tested with our AIDS vaccine to date in the U.S. and Europe. Consequently, Newsweek (summer 1998) listed our vaccine as one of the three leading AIDS vaccines in advanced clinical trials.

    In animal and human studies, this vaccine has been shown to generate immune responses that potentially recognize the major HIV subtypes, representing more than 90% of the world's AIDS cases.

    But the main question remains: Does CEL-SCI have evidence of protection against infection with its vaccine? We believe the answer is yes.

    Five uninfected human volunteers who had received the vaccine and three uninfected, non-vaccinated volunteers donated blood for virus challenge studies. Their blood cells were injected into SCID mice, that are genetically engineered not to reject human cells. These mice were then injected with the live AIDS virus.

  • Result: 78% of the mice that received blood from vaccinated human volunteers were protected from infection, while only 13% that received blood from non-vaccinated volunteers showed protection.

    Putting It All into Perspective:

    Looking back, we see how much CEL-SCI has matured. During the past few years we have gone from having only a license for Multikine to being the exclusive owner of three distinct, yet complementary patented technologies, two of which have products in phase II clinical trials.

    Along the way, we overcame major hurdles and challenges. Many of our original competitors have faded while we were making advances. Our advances now form a solid foundation from which we can accelerate our work.

    We believe that 1999 will be a watershed year for our Company. During 1999 alone we expect to generate more human clinical trial data than in all prior years combined. We believe that the combination of positive data, such as we have obtained to date with Multikine, will allow our Company to initiate a pivotal Multikine study next year. Positive data from human clinical trials, together with our experienced management team, will provide the key to the success of the Company.

    We thank you for supporting CEL-SCI during the past year and we look forward to your continued support in the future.

    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.

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