Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
1992-06-03
2004-03-09
Travers, Russell (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
Reexamination Certificate
active
06703418
ABSTRACT:
BACKGROUND OF THE INVENTION
Among the many problems endured by patients suffering from symptomatic HIV infection, which includes inter alia AIDS (Acquired Immune Deficiency Syndrome) and ARC (AIDS Related Complex), are loss of appetite with consequent loss of weight. This loss of appetite and loss of weight further debilitates the patients and increases the many problems associated with the HIV infection.
The compound delta-9-tetrahydrocannabinol, which is the active ingredient in marijuana and which was produced chemically as described in U.S. Pat. No. 3,668,224, has been used as an antiemetic to relieve nausea and vomiting in patients receiving cancer chemotherapy.
A number of cancer investigators have used delta-9-tetrahydrocannabinol to attempt to increase appetite and modify weight loss in cancer patients. For example, in a randomized double-blind crossover study employing oral delta-9-tetrahydrocannabinol and prochlorperazine, 50% of the subjects on delta-9-tetrahydrocannabinol reported an increased food intake while only 29% had a similar response on the prochlorperazine.
1
In another study of similar design and using the same medications, patients on delta-9-tetrahydrocannabinol reported feeling more hungry than patients on prochlorperazine.
2
Results suggestive of an appetite stimulating effect were also noted by Ekert, et al.
3
in groups of children and adolescents 6-19 years of age administered delta-9-tetrahydrocannabinol, prochlorperazine or metaclopramide in crossover design studies.
1
Sallan, S E; Cronin, C; Zelen, M; and Zinberg, N E (Sidney Farber Cancer Institute, Boston, Mass.): Antiemetics in patients receiving chemotherapy for cancer. A randomized comparison of delta-9-tetrahydrocannabinol and prochlorperazine. N. Engl. J. Med. 301:135-138 (Jan. 17) 1980, No. 3.
2
Ungerleider, J T; Andrysiak, T; Fairbanks, L; Gooodnight, J; Sarna, G; and Jamison, K. (UCLA Center for the Health Sciences, Los Angeles, Calif.): Cannabis and cancer chemotherapy. A comparison of oral delta-9-THC and prochlorperazine. Cancer 50:636-645 (Aug. 15) 1982, No. 4.
3
Ekert, H; Waters, K D; Jurk, I H; Mobilia, J; and Loughnan, P. (Royal Children's Hospital, Melbourne, Australia): Amerlioration of cancer chemotherapy-induced nausea and vomiting by delta-9-tetrahydrocannabinol. Med. J. Aust. 2:657-659 (Dec. 15) 1979.
In a double blind study, Regelson, et al.
4
observed that advanced cancer patients on chemotherapy receiving delta-9-tetrahydrocannabinol maintained their weight better than those not receiving the delta-9-tetrahydrocannabinol.
4
Regelson W, Butter J R; Schultz J; Kirk T; Peek L; Green M L; Delta-9-tetrahydrocannabinol, (delta-9-THC) as an effective antidepressant and appetite-stimulating agent in advanced cancer patients. The pharmacology of marihuana, (Braude M C & Szara S eds) Raven Press, N.Y. (1976; pp. 763-766.
In an open study, Wadleigh, et al.
5
observed appetite increases and a lessening of the rate of weight loss in cancer patients.
5
Wadleigh, R; Spaulding, M; Lembersky, B; Zimmer, M; Shepard, K; Plasse, T: Dronabinol enhancement of appetite in cancer patients. Proceedings, 1990 American Society of Clinical Mycology Meeting.
SUMMARY OF THE INVENTION
It is accordingly a primary object of the present invention to provide for the treatment of patients suffering from symptomatic HIV infection so as to improve the appetite and induce weight gain in such patients.
Other objects and advantages of the present invention will be apparent from a further reading of the specification and of the appended claims.
With the above and other objects in view, the present invention mainly comprises the administration to a patient suffering from symptomatic HIV infection of an appetite stimulating effective amount of delta-9-tetrahydrocannabinol.
The delta-9-tetrahydrocannabinol is preferably administered orally as dronabinol (delta-9-tetrahydrocannabinol in sesame oil-containing capsules). Administration is also possible to achieve the effects of the present invention when the delta-9-tetrahydrocannabinol is in the form of tablets, suppositories, intranasal administration, transdermal administration, inhalants and sublingual administration, as well as administration by injection.
Side effects, such as nausea and CNS effects, may vary with the dosage of the delta-9-tetrahydrocannabinol. It is a further object of this invention to optimize the dosage regimen so as to minimize such side effects.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The following is given to further illustrate the present invention. The scope of the invention is not, however, meant to be limited to the specific details thereof.
REFERENCES:
Vaupel, D. B. et al, Pharmacol Biochem Behav 17(3): 539-545 (1982).*
Noyes, R, et al, Comp Psychiatry 17(5): 641-646 (1976).*
Gorter, R., Management ofAnorexia-cachexiaAssociated with Cancer and HIV Infection, Supplement Oncology, vol. 5, No. 9, p. 13-17, (1991).
Friedman H., Klien T., Specter S., Pross S., Newton, C., Blanchard DK., Widen R., Drugs of Abuse and Virus Susceptibility, Psychological Neuropsychiatric and Aspects of Aids, Raven Press, New York, (1998), p. 125-137.
Noe SN., Nyland SB, Ugen K., Friedman H., Klein TW., Cannabinoid Receptor Agonists Enhance Sycytia Formation in MT-2 Cells Infected With Cell Free HIV-1 mn,Drugs of Abuse, Immunomodulation, and AIDS,p. 223-229, (1998).
Srivastava MD., Srivastava BIS., Brouhard B., Tetrahydrocannabinol and Cannabidiol Alter Cytokine Production by Human Immune Cells, Immunopharmacology 40 p. 179-185 (1998).
Harkins T., Herriott KB., Medical Management of Acquired Immune Deficiency Syndrome Patients: a Review, J. of The American Optometric Association, vol. 63, No. 1, p. 35-42, (1/92).
Anderson, P.O. and G.G. McGuire, “Deltra-9-tetrahydrocannabinol as an Antiemetic,” Am. J. Hosp. Pharm., 38: 639-46 (1981).
MacGregor, R.R., “Alcohol and Drugs as Co-Factors for AIDS,” Adv. Alcohol Subst. Abuse, 7(2):47-71 (1987).
Pillai, R.M., and R.R. Watson, “In vitro Immunotoxicology and Immunopharmacology: Studies on Drugs of Abuse,” Toxicology Letters, 53: 269-283 (1990).
Pillai et al., “AIDS, Drugs of Abuse and the Immune System: A Complex Immunotoxicological Network,” Arch. Toxicol., 65: 609-617 (1991).
Pross et al., “Differential Suppression of T-Cell Subpopulations By THC (Delta-9-Tetrahydrocannabinol),” Int. J. Immunopharmac., 12(5): 539-544 (1990).
Schwartz C.J., “AIDS and Marijuana Use,” Hosp Community Psychiatry., 38(5):530-1 (1987).
Specter et al., “Combined Immunosuppressive Activities of Delta-9-Tetrahydrocannabinol and Murine Retrovirus,” Adv. Exp. Med. Biol., 288:135-141 (1991).
Specter et al., “Delta-9-Tetrahydrocannabinol Augments Murine Retroviral Induced Immunosuppression and Infection,” Int. J. Immunopharmac., 13(4): 411-417 (1991).
Tidall et al., “The Sydney AIDS Project: Development of Acquired Immunodeficiency Syndrome in a Group of HIV Seropositive Homosexual Men,” Aust. NZ J. Med, 18: 8-15 (1988).
Barry Amanda T.
Mahoney Joseph A.
Mayer Brown Rowe & Maw LLP
Travers Russell
Unimed Pharmaceuticals, Inc.
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