Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Patent
1994-08-23
1996-10-08
Naff, David M.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
424529, 424534, 424530, 435 704, 435 705, 4352402, 43524021, 530350, 530351, 530412, 530415, 530416, 530419, 530421, A61K 3702, A61K 3516, C12P 2104, C07K 312
Patent
active
055631207
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention relates to a novel cytokine composition, a method for its preparation, and the use of the preparation in the immunotherapy of various diseases such as bacterial infections, viral infections and cancers.
BACKGROUND OF THE INVENTION
The immune system provides defence for the body against infectious agents such as bacteria, viruses, fungi and parasites. More recently, it has been shown that the state of the immune system can be linked to the susceptibility to developing certain types of cancers. For example, it has been shown that in certain immune deficient states, most notably Acquired Immune Deficiency Syndrome (AIDS), the incidence of cancer is greatly increased. Immunotherapy has become an important therapy against various infectious agents and even in the treatment of cancer. One branch of immunotherapy involves using immunomodulating agents that can modulate, induce or increase the immune response.
One group of immunomodulating agents that has been extensively studied includes the cytokines. Cytokines are the chemical messengers of the immune system and are produced by immune cells such as lymphocytes and monocytes. One cytokine, namely interferon (IFN), has been shown not only to induce the immune system but also to act directly on tumors to inhibit proliferation of the tumor cells. Interferon is well known in the art. Details on its characterization as well as methods for its preparation can be found in Methods in Enzymology, Volume 119, "Interferons, PART C" 1986.
Although both crude as well as purified preparations of cytokines, such as interferon, are currently available, the problems with these known preparations include the following. Crude preparations generally contain proteinases which break down the cytokines and thereby decrease the stability of the preparation. Proteinase inhibitors are available but these are generally toxic or antigenic to man and thus are not useful in therapeutic applications. On the other hand, while purified interferon is generally proteinase free, the methods for purifying interferon known to date generally result in a poor yield of interferon. Furthermore, the biological activity of a purified preparation is generally lower than that of a crude interferon preparation.
Early in the 80s, it was observed that a crude preparation of interferon activated human natural killer cells (NK) more effectively than purified IFN prepared from the same batch of crude IFN. As shown in Table A the highest degree of NK activation can be achieved with a crude IFN titer of 50 IU/ml and a purified IFN titer of 625 IU/ml. These titers resulted in activation of the NK cells of 550% and 600%, respectively. From this data it was concluded that crude IFN has a higher potential of immunoactivation which is likely due to the presence of some other cytokines together with IFN.
It was later found that mixed cultures of donor Leukocytes produced (in response to viral induction and interaction of cells with different genotypes) cytokines as such as Interleukin-1 (IL-1), Tumor Necrosis Factor (TNF), Migration Inhibition Factor (MIF), Leucocyte Migration Inhibition Factor (LIF), together with IFN-.alpha.. It is known that these cytokines participate in the activation of immune effector cells (mainly macrophages, T.sub.4 -lymphocytes, neutrophils) and participate in the immune recognition of antigen and its elimination from the body. These reactions present the first stage of the immune response manifested by effectors in response to an antigen encounter. Amplification of immune response, developing specific humoral reactions and memory cells are events that occur later and depend on effective immune reactions in the first (non-specific) stage of immune response.
The cytokines such as IFN, IL-1, TNF, MIF and LIF, have different physico-chemical properties, therefore it is very difficult to retain composition that is active and composed of a mixture of the cytokines preparation after chemical purification procedures. Furthermore, for medical preparatio
REFERENCES:
patent: 4696899 (1987-09-01), Toth et al.
Kuznetsov et al, `The Complex Preparation of Ifn-Alpha and Cytokines-Leukinferon for Injections (LF): Immunobiological Properties, Clinical Effectiveness` (Abstract), Journal of Interferon Research, vol. 10, No. S1, Nov. 1990, New York, USA p. S175.
Botsvadze et al, `Treat Acute Hepata Consist Course Specified Medicine Preparation Prescribed Manner Increase Efficiency`, Database WPI, Week 9245 Derwent Publications Ltd., London, Great Britain, Dec. 1991 (Abstract).
Horowitz, B., Methods in Enzymology, ed. Pestka, vol. 119, Academic Press, Inc., N.Y. 1986, pp. 39-47.
Intelcor Biotech Enterprises, Inc.
Naff David M.
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