Date: Thu, 18 Dec 1997 18:09:24 GMT Server: Stronghold/1.3.4 Ben-SSL/1.3 Apache/1.1.3 Content-type: text/html Content-length: 15175 Last-modified: Mon, 06 Oct 1997 14:22:02 GMT
![]() |
![]() |
![]() |
![]() |
![]() |
frequently asked questions Multikine Why do you think that Multikine can be successful? Multikine, quite simplistically, is a copy of a healthy person’s immune response. If you believe in the effectiveness of your own immune system, you have to believe that Multikine will help patients whose immune system is weakened by disease. Earlier clinical studies showed rapid tumor responses in terminal cancer patients with no toxic side effects. Where are you in your clinical studies with Multikine? We are in phase I/II trials against head and neck cancer in the U.S., Canada and Israel, in phase I against prostate cancer in the U.S., and in phase I against AIDS in the U.S. How big is the market for Multikine? Prostate cancer is the number two cancer in men in the U.S. with over 300,000 new cases per year in the U.S. alone. Head and neck cancer has 500,000 annual new cases worldwide. An immune boosting product for AIDS patients should find rapid acceptance among the large number of AIDS patients. In short, there is a substantial market need. Who are your competitors? We currently focus on diseases not properly served by the current state of medicine. Multikine, if successful, should have advantages in terms of effectiveness and quality of life. Where do you manufacture Multikine? We have built a manufacturing facility and laboratory in Baltimore, Maryland. Is Multikine patent protected? Yes, it is patent protected. However, equally important is the fact that the manufacture of Multikine is an art form that required us to develop many techniques and tests not previously available. We refer to this as our “Coca-Cola Formula” and like Coca-Cola, we will keep it confidential. HGP-30 AIDS Vaccine Why do you think that your AIDS vaccine can be successful when so many have already failed? Quite simple! The vaccines that failed almost exclusively focused on parts of the HIV virus which mutate rapidly. As such it is practically impossible to confer protection against next year’s new AIDS strains because you do not know what they will look like. In addition, these vaccines were mostly designed to produce antibodies, which cannot kill the virus infected cells. CEL-SCI, on the other hand, focused on a region of the AIDS virus that is much more constant. Since it will not be much different next year, you can teach the body to recognize future strains and fight them. In addition, CEL-SCI focused on killer T-cells to destroy the virus infected cells, the factories for new virus. Can you become HIV infected from our vaccine? No! HGP-30 is an artificial copy of a region of the AIDS virus, not the virus itself. What have you seen in your human studies? HGP-30 has been tested in 39 volunteers not infected with the virus in the U.K. and the U.S. It has also been tested with 24 AIDS infected patients in the U.S. In these studies, HGP-30 has been shown to be safe and to induce the type of immune responses thought to be important in fighting HIV. Do you have any evidence of protection with HGP-30 against AIDS infection? Yes. CEL-SCI is the only group to have documented substantial protection against a different strain of the HIV virus than the one from which the vaccine was developed. Where are you in your clinical studies? We are currently preparing for a phase II study to start in the second half of 1997. Results permitting, we plan to enter into a large phase III HIV prevention study in 1998. This study will be conducted in a third world country that has high levels of HIV infection. Only by going to a country with such high levels of HIV infection can you get a relatively fast answer to the question: “Does the vaccine protect against AIDS infection in a real life setting?” The results of this study may form the basis for a product approval. Is HGP-30 patent protected? Yes, and more patent applications have been filed during the past year. Where do you manufacture HGP-30? HGP-30 is a peptide. There are a multitude of capable contract manufacturers available. Therefore, CEL-SCI does not have a need for its own manufacturing plant right now. L.E.A.P.S. Heteroconjugate What does L.E.A.P.S. stand for? Ligand Epitope Antigen Presentation System. Early research indicates that it is a system whereby, through the use of a “Ligand” attachment, you can tell the immune system how to process an antigen (e.g. vaccine like HGP-30). This may let you direct the body’s immune system in a way that leads to greater success in fighting or preventing a disease. Is L.E.A.P.S. patent protected? Yes, and additional applications are anticipated for future products utilizing this technology. What diseases are you currently pursuing with L.E.A.P.S.? Internally we are pursuing HIV in combination with HGP-30, as well as tuberculosis. Externally, we are pursuing malaria with the U.S. Navy and herpes simplex with Northeastern Ohio Universities College of Medicine. These diseases are in dire need of effective treatments and vaccines. If only one of them turns out to lead to a successful product, shareholders should be quite happy. When will L.E.A.P.S. enter into clinical trials? We hope to have at least one L.E.A.P.S. product in human clinical studies in 1998.
|
![]() |
![]() |
![]() |
Home Publications Mission Shareholder Letter Product Chart Basics Questions Corporate FY96 Employment |
![]() |
![]() |
![]() |
66 Canal Center Plaza Suite 510 |
![]() |
![]() |
![]() |
![]() |
![]() |
|
|
|||||
66 Canal Center Plaza Suite 510 |
|||||
![]() |
![]() |
![]() |