WO OJ/O20296
PCT/USO2/27579
EXAMPLE 9
Effect of Noni Juice Concentrate on Psoriasis
(0063J To test the effectiveness of a Noni juice concentrate on psoriasis, patients were selected at the Louisiana State University Health Science Center (LSUHSC) after signing a consent form. approved by the LSUHSC Institutional Review Board. An patients were asked to continue using whatever therapy they had been using for the psoriasis. Each patient was given two distinct 8 gm jars of a gel, one a gel with Noni and one a control gel. The jars did not indicate which contained the Noni juice. The patients were randomly divided on which arm (right or left) would be treated with the Nom gel, with the other arm treated with the control gel.
The patients were asked to treat the affected area topically twice a day. Pre-study photographs of psoriatic lesions on the Noni-treated and control-treated extremities were taken. Patients were
monitored and photographed weekly or bi-weekly. Patients were also asked to rate the condition of their skin. An unbiased observer was asked to rate the lesions or plaques on the skin, using a 9-point grading system. The 9-point grading system was the sum of a grade of 0 to 3 for each of three categories -- erythema, scale, and elevation.
[0064]
Noni juice gel was prepared by freeze-drying Nom juice into a powder. The powder was compounded into a gel at a concentration of about 20% wt/vol, by initially using rosewater in a volume equal to two-thirds of the total to attempt to camouflage the pungent odor of Noni. Then Krisgel liquid, cellulose hydroxy propyl ether (Professional Compounding Centers of America. Houston. Texas), was added to bring the volume to the final total, and the combination was mixed until it gelled. The control was the same rosewater/Krisgel liquid mixture without the Noni.
(0065) To date, six patients have been studied. All six patients reported that the Noni
containing gel had an unpleasant smell and stained the skin a brown color that was easily removed with soap and water. All six patients felt that plaques treated with Nom showed improvement. As rated by the patients, the total score for the Noni arm decreased by3.6, while the score for the other arm only decreased by 0.5. As rated by the independent observer, the total score for the Noni arm decreased by 3.1 in the Noni-treated arm, while the score for the other arm only decreased by 0.2.
[0066) This experiment showed that Nom juice applied topically as a gel was effective
in treating skin lesions associated with psoriasis in humans.
(0067)
In similar experiments. Noni juice or an angiogenic extract will be tested for effectiveness of a topical administration against other skin disorders that involve angiogenesis. e.g.. Kaposis sarcoma and some skin cancers.
EXAMPLE 10
Effectiveness of Noni Juice 011 Angiogenesis in Breast Cancer Explants.
[0068)
Explants from human breast cancer tissue were obtained from an anonymous discarded surgical specimen under the approval of an Institutional Review Board. The cancer tissue came from a tumor with a size greater than 1 cm3. Cubes of about 2 mm on each side were excised and plated in well plates. The explants were treated with Medium 199 supplemented with 20% fetal bovine serum and either 10% NaCI (control) or 10% Noni juice. The medium in each well was changed, and the discs scored every two days.
(0069) Noni juice was very effective in suppressing angiogenic initiation (Fig. lOa), and
in inhibiting angiogenic proliferation (Fig. lOb) in the breast cancer explants.
.jpg)