Claims for Patent: 6,277,418

Summary for Patent: 6,277,418

Title:	Corn extract contraceptive
Abstract:	Novel compositions extracted from corn products provide contraceptive and anti-neoplastic activities. Using novel extraction procedures, compositions may be isolated from corn products. For example, a Zea mays plant product is extracted in a first solvent to produce a solvent extract, the solvent extract is dried to produce an extracted solid, the extracted solid is solubilized in a second solvent, the solubilized extract is purified in a chromatographic process, and an active fraction is collected from the chromatographic process. Compositions may be applied to animal bedding or food, and are adaptable to any suitable method of administration. The contraceptive activity of these compositions is effective for both males and females.
Inventor(s):	Markaverich; Barry M. (The Woodlands, TX), Faith; Robert (Houston, TX), Mani; Shaila (Houston, TX)
Assignee:	Baylor College of Medicine (Houston, TX)
Application Number:	09/311,751
Patent Claims:	1. A process for producing an antineoplastic substance comprising: extracting a Zea mays plant product in a first solvent to produce a solvent extract, wherein said Zea mays plant product is selected from the group consisting of corn kernel, corn cob, animal bedding material made from corn cob, and mixtures thereof and wherein said first solvent comprises a solar solvent; drying said solvent extract to produce an extracted solid; solubilizing said extracted solid in a second solvent; purifying said solubilized extract in a chromatographic process; collecting an active fraction from said chromatographic process said active fraction being the antineoplastic substance and having antineoplastic activity. 2. The process of claim 1 wherein said animal bedding material is ground corn cob bedding. 3. The process of claim 1 wherein said first solvent is selected from the group consisting of alcohols, ethers, ketones, water and mixtures thereof. 4. The process of claim 3 wherein said alcohol is methanol. 5. The process of claim 1 wherein said first solvent and said second solvent are the same. 6. The process of claim 1 wherein said extracting step is from 1 hour to 1 month. 7. The process of claim 1 wherein said extraction step is carried out at a temperature between 0.degree. C. and 100.degree. C. 8. The process of claim 1 wherein said chromatographic process is a procedure selected from the group consisting of column chromatography, batch chromatography, precipitation, specific adsorbent chromatography, gel filtration, and combinations thereof. 9. The process of claim 8 wherein said column chromatography is a reverse phase chromatography column comprising a C.sub.18 solid phase and a methanol/water liquid phase. 10. The process of claim 1 wherein said active fraction is a fraction of about 80% methanol. 11. The antineoplastic substance produced by the process of claim 1. 12. A pharmaceutical preparation comprising the antineoplastic substance produced by the process according to claim 1 and a pharmaceutically acceptable carrier. 13. The pharmaceutical preparation of claim 12 prepared in the form of an aqueous solution. 14. The pharmaceutical preparation of claim 13 wherein said aqueous solution is for oral use or parenteral use. 15. The pharmaceutical preparation of claim 12 prepared in the form of capsules for oral use. 16. The pharmaceutical preparation of claim 12 prepared in the form selected from the group consisting of unguents, ointments, creams, suppositories and ovules. 17. A method for treating a patient with a neoplastic disorder comprising administering to the patient an antineoplastic composition comprising an effective quantity of the antineoplastic substance of claim 1. 18. The method of claim 17 wherein said antineoplastic composition further comprises an antineoplastic compound. 19. The method of claim 18 wherein said antineoplastic compound is methotrexate. 20. The method of claim 18 wherein said antineoplastic compound is selected from the group consisting of 5-fluorouracil, 6-mercaptopurine, 6-thioguanine, alkylating agents, androgens, antiadrenals, antiandrogens, antiestrogens, antimetabolites, asparaginase, bleomycin, busulfan, carboplatin, carmustine, chlorambucil, cisplatin, corticosteroids, cyclophosphamide, cytarabine, dacarbazine, dactinomycin, daunorubicin, doxorubicin, estrogens, etoposide, fludarabine, fluorouracil, flutamide, hexamethylmelamine, hormones, hydroxyurea, hypothalamic agents, idarubicin, ifosfamide, intrapleural, lomustine, mechlorethamine, melphalan, methotrexate, mithramycin, mitomycin, mitotic inhibitors, mitoxantrone, pacelitaxel, procarbazine, progestins, streptozocin, taxol, thiotepa, vinblastine, vincristine, vinorelbine and combinations and analogs thereof. 21. The method of claim 17 wherein said neoplastic disorder is selected from the group consisting of prostate cancer, breast cancer, lymphoma, leukemia, testicular cancer, gastrointestinal tract cancer, lung cancer, skin cancer, head tumors, neck tumors, bone cancer, liver cancer, and pancreatic cancer. 22. The method of claim 17 further comprising the step of administering an antineoplastic compound. 23. The method of claim 22 wherein the antineoplastic compound is methotrexate and the neoplastic activity is breast cancer cell proliferation. 24. The method of claim 17 wherein the extract is administered orally, topically, intramuscularly, intravenously, subcutaneously, vaginally, rectally, or by pulmonary absorption. 25. An antineoplastic substance produced by a process comprising the steps of extracting a Zea mays plant product in a first solvent to produce a solvent extract, wherein said Zea mays plant product is selected from the group consisting of corn kernel, corn cobs animal bedding material made from corn cob, and mixtures thereof, and wherein said first solvent comprises a solvent selected from the group consisting of alcohols, ethers, ketones, water and mixtures thereof; drying said solvent extract to produce an extracted solid; solubilizing said extracted solid in a second solvent; purifying said solubilized extract in a chromatographic process; collecting an active fraction from said chromatographic process, said active fraction being the antineoplastic substance and having antineoplastic activity. 26. A method of inhibiting neoplastic activity comprising administering an effective amount of the antineoplastic substance of claim 25 to tissues or cells. 27. A method of treating an individual with a neoplastic disorder comprising administering to the individual an effective amount of the antineoplastic substance of claim 25.

Details for Patent 6,277,418

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	01/10/1978		2018-06-02