Abstract: A second generation of antineoplaston therapies with markedly improved antineoplastic activity is disclosed. Among others, members of the antineoplaston family include phenylacetate (PN), 3-phenylacetyl-amino-2, 6, piperidinedione (CN), and hydrolysis derivatives of CN: phenylacetylglutamine (PG) and isophenylacetylglutamine (Iso-PG). In part, these increases in antineoplastic activity result from large increases in the transport of antineoplaston compositions into cells. Importantly and unexpectedly these increases in antineoplastic activity also result from the capacity of the drug delivery system to direct antineoplaston compounds intracellular trafficking to intracellular binding sites influencing cell viability and proliferation. Liposomal formulations of antineoplaston compositions increase in vitro antineoplastic activity by a factor of 750 to 1500 as compared to administration of antineoplaston compounds given without liposomal formulations.

Abstract: The present invention provides methods for treating autoimmune disease in humans by administering to an afflicted host pharmaceutical compositions containing a therapeutically effective amount of a combination of ##STR1## in a weight ratio ranging from about 1:1 to about 1:10 (A:B); wherein R is OH, NH.sub.2, OW, or H;X is H, F, Cl, Br, I, OH, OW, NO.sub.2, or NH.sub.2 ;Y is H, F, Cl, Br, or I;W is ##STR2## or a C.sub.1 to C.sub.12 aliphatic group; Z is an aliphatic or aromatic group of C.sub.1 to C.sub.12 ;X and Y can both vary within the compound; or pharmaceutically acceptable salts thereof.Particularly disclosed herein is a composition comprising a 1 to 4 ratio of the sodium salts of phenylacetylglutamine and phenylacetic acid, formulated in both oral and parenteral forms clinically useful in the treatment of rheumatoid arthritis, lupus erythematosus, vasculitis, insulin dependent diabetes mellitus and multiple sclerosis.

Abstract: The present invention provides methods for treating neurofibromatosis in humans by administering to an afflicted host pharmaceutical compositions containing a therapeutically effective amount of a combination of ##STR1## in a weight ratio ranging from about 1:1 to about 1:10 (A:B); wherein R is OH, NH.sub.2, OW, or H;X is H, F, Cl, Br, I, OH, OW, NO.sub.2 or NH.sub.2 ;Y is H, F, Cl, Br, or I;W is ##STR2## or a C.sub.1 to C.sub.2 aliphatic group; Z is an aliphatic or aromatic group of C.sub.1 to C.sub.12 ;X and Y can both vary within the compound; orpharmaceutically acceptable salts thereof.Particularly disclosed herein is a composition comprising a 1:4 ratio of the sodium salts of phenylacetylglutamine and phenylacetic acid, formulated in both oral and parenteral forms. Typically, the patient is given the combination composition from 1 to 20 g/day in divided doses. After several months of treatment patients exhibit significant decrease in number and size of nodules.

Abstract: The present invention provides methods for treating AIDS-related diseases by administering to an afflicted host pharmaceutical compositions containing a therapeutically effective amount of substituted piperidinedione of the formula ##STR1## or mixtures thereof, whereinR is OH, NH.sub.2, OW, or H;X is H, F, Cl, Br, I, OH, OW, NO.sub.2, or NH.sub.2 ;Y is H, F, Cl, Br, or I;W is ##STR2## or a C.sub.1 to C.sub.12 aliphatic group; Z is an aliphatic or aromatic group of C.sub.1 to C.sub.12 ;X and Y can both vary within the compound; and pharmaceutically acceptable salts thereof.The pharmaceutical compositions further may include R,X,Y substituted phenylacetic acid.

Abstract: The present invention provides methods for treating viral diseases in humans by administering to an afflicted host pharmaceutical compositions containing a therapeutically effective amount of a combination of ##STR1## in a weight ratio ranging from about 1:1 to about 1:10 (A:B); wherein R is OH, NH.sub.2, OW, or H; X is H, F, Cl, Br, I, OH, OW, NO.sub.2, or NH.sub.2 ; Y is H, F, Cl, Br, or I; W is ##STR2## or a C.sub.1 to C.sub.12 aliphatic group; Z is an aliphatic or aromatic group of C.sub.1 to C.sub.12 ;X and Y can both vary within the compound; or pharmaceutically acceptable salts thereof.Particularly disclosed herein is a composition comprising a 1 to 4 ratio of the sodium salts of phenylacetylglutamine and phenylacetic acid, formulated in both oral and parenteral forms clinically useful in the treatment of herpes virus, HIV, human papilloma virus, rhinovirus, coronavirus, orthomyxovirus and paramyxovirus.

Abstract: The present invention provides methods for treating Parkinson's disease by administering to an afflicted host pharmaceutical compositions containing a therapeutically effective amount of urine peptide fractions containing 3-[N-phenylacetylaminopiperidine]-2,6-dion.

Abstract: The present invention provides methods for treating AIDS-related diseases by administering to an afflicted host pharmaceutical compositions containing a therapeutically effective amount of substituted piperidinedione of the formula ##STR1## or mixtues thereof, wherein R is OH, NH.sub.2, OW, or H;X is H, F. Cl, Bri, I, OH, OW, NO.sub.2, or NH.sub.2 ;Y is H, F. Cl, Bri, or I;W is ##STR2## or a C.sub.1 to C.sub.12 aliphatic group; Z is an aliphatic or aromatic group of C.sub.1 to C.sub.12 ;X and Y can both vary within the compound; and pharmaceutically acceptable salts thereof.The pharmaceutical compositions further may include R,X,Y substituted phenylacetic acid.

Abstract: Disclosed is a process for synthesizing 3-[N-phenylacetylaminopiperidine]-2,6-dion, which process comprises the steps of providing a quantity of L-glutamine, providing a quantity of phenylacetyl halide, mixing together the L-glutamine and phenylacetyl halide in a weakly alkaline aqueous solution to provide an aqueous reaction mixture, adjusting the reaction mixture to a pH ranging from about 2 to about 3, and recovering from the reaction mixture the product 3-[N-phenylacetylamino-piperidine]-2,6-dion, and when desired preparing the pharmaceutically acceptable salts thereof.

Abstract: A cosmetic composition is provided which comprises 3-phenylacetylamino-2,6-piperidinedione dispersed in a cosmetically suitable vehicle. This cosmetic composition is useful in the topical cosmetic treatment of skin areas affected with wrinkles or hyperpigmentation.

Abstract: Highly purified fractions from human urine exhibiting antineoplastic activity and processes for their preparation are described. The fractions comprise biologically active, small sized, low molecular weight peptides which exert cytostatic and cytotoxic activity toward neoplastic cell cultures and human neoplastic diseases. The fractions have been termed antineoplaston fractions. An antineoplastic active peptide common to each of the various antineoplaston fractions has been isolated and identified as 3-[N-phenylacetylaminopiperidine]-2, 6-dion. A synthetic mechanism for the preparation of 3-[N-phenylacetylaminopiperdine]-2,6-dion is also disclosed, involving a combination reaction between L-glutamine and phenylacetyl chloride. Also disclosed are the hydrolysis degradation products of 3-[N-phenylacetylaminopiperidine]-2, 6-dion which also exhibit antineoplastic activity when administered according to the general teachings presented in this disclosure.

Abstract: Highly purified fractions from human urine exhibiting antineoplastic activity and processes for their preparation are described. The fractions comprise biologically active, small sized, low molecular weight peptides which exert cytostatic and cytotoxic activity toward neoplastic cell cultures and human neoplastic diseases. The fractions have been termed antineoplaston fractions. An antineoplastic active peptide common to each of the various antineoplaston fractions has been isolated and identified as 3-[N-phenylacetylaminopiperidine]-2, 6-dion. A synthetic mechanism for the preparation of 3-[N-phenylacetylaminopiperdine]-2, 6-dion is also disclosed, involving a combination reaction between L-glutamine and phenylacetyl chloride. Also disclosed are the hydrolysis degradation products of 3-[N-phenylacetylaminopiperidine]-2, 6-dion which also exhibit antineoplastic activity when administered according to the general teachings presented in this disclosure.

Abstract: Highly purified fractions from human urine exhibiting antineoplastic activity and processes for their preparation are described. The fractions comprise biologically active, small sized, low molecular weight peptides which exert cytostatic and cytotoxic activity toward neoplastic cell cultures and human neoplastic diseases. The fractions have been termed antineoplaston fractions. An antineoplastic active peptide common to each of the various antineoplaston fractions has been isolated and identified as 3-[N-phenylacetylaminopiperidine]-2, 6-dion. A synthetic mechanism for the preparation of 3-[N-phenylacetylaminopiperdine]-2, 6-dion is also disclosed, involving a combination reaction between L-glutamine and phenylacetyl chloride. Also disclosed are the hydrolysis degradation products of 3-[N-phenylacetylaminopiperidine]-2, 6-dion which also exhibit antineoplastic activity when administered according to the general teachings presented in this disclosure.

Abstract: Antineoplastons are termed a group of plasma, tissue and urinary peptides and amino acid derivatives capable of modulating abnormal tissue growth, such as neoplastic disease. Antineoplastons, when administered to persons with neoplastic disease, have been shown to be effective against several forms of cancer and tumors. A procedure is provided herein for the determination of antineoplaston levels in physiological tissues or fluids, especially plasma and urine. The procedure involves purification of antineoplastons by high performance liquid chromatography on silica gel followed by resolution of antineoplastons by high performance liquid chromatography on sulfonated polystyrene. A quantitative determination of antineoplaston tissue or fluid levels provides valuable data to aid clinical diagnosis of cancer. In addition, the quantitative determination also provides a means for monitoring the efficacy of antineoplastic therapy.