Ibogaine in the treatment ofchronic hepatitis C

Howard S. Lotsof.President

Dora Weiner FoundationStaten Island, NY

http://www.doraweiner.org

Invitational Ibogaine forumWarsaw 2007

Wednesday 16 MayHotel Sofitel Victoria

Tabernanthe ibogasource of ibogaine

Found in West African rain forests

Purified Ibogaine HCl

Courtesy Jason CallanPresident and FounderEthnogarden Botanicalwww.ethnogarden.com

Ibogaine HClpharmaceutical grade

99.4% purity

1973: Non A, Non B hepatitis is described

1989: HCV RNA virus identified

1990: Anti HCV effects of ibogaine

reported

2005: Patent application for ibogaine to

treat chronic HCV filed

Hepatitis C (HCV)timeline

Most common viral infection in the

United States

New infections per year 1990 - 242,000New infections per year 2001 - 25,000New infections per year 2004 - 25,000Greater than 75% of IVDUs test

positive

HCV infection

1. The discovery of ibogaine’s use in treating both chemical dependence and HCV was by ibogaine activist advocates who were themselves treated or self-treated with ibogaine.

2. Scientific research followed patent development in the treatment of chemical dependence and it is hoped the same will be true for ibogaine related HCV research.

Science follows patent development

1. Rapid method for interrupting the narcotic addiction syndrome, US 4,499,096 (1985)

2. Rapid method for interrupting the cocaine and amphetamine abuse syndrome US 4,587,243 (1986)

3. Rapid method for attenuating the alcohol dependency syndrome, US 4,957,523 (1989)

4. Rapid method for interrupting or attenuating the nicotine/tobacco dependency syndrome, US 5,026,697 (1991)

5. Rapid method for interrupting or attenuating poly-drug dependency syndromes, US 5, 124,994 (1992)

Ibogaine Patents

1. Broad ranging claims of ibogaine to treat multiple forms of chemical doubted

2. Over time, all claims for chemical dependence have been confirmed by research

a) Opioids,

b) stimulants,

c) Alcohol

d) nicotine

Research follows skepticism

Opioids

Cocaine

Alcohol

Nicotine

• International Coalition for Addict Self-Help (ICASH) 1989

• Dutch Addict Self-Help (DASH) 1990

• Ibogaine Underground 2004

Ibogaine activist organizations play

role in ibogaine HCV research

HCV patent application

Example 1 Report

A thirty-three year old male diagnosed with HCV and using 1/4 gram of heroin a day was administered 25 mg/kg ibogaine HCl. Following administration of ibogaine heroin use ceased along with swelling of the liver and pain in the area of the liver.

Example 2 Liver enzyme values reduced

by 14 mg/kg ibogaine

Enzyme Pre Post

ALT 410 50

AST 201 25

GGT 155 33

Example 3

A sixty year old male testing positive for HCV RNA genotype I, administered the following dose regimens of ibogaine HCl. Subject weighed 79 kg. Doses administered were as total doses and not mg/kg. Day 1: 10 mg, Day 2: 20 mg, Day 3: 20 mg, Day 4: 30 mg, Day 5: 50 mg, Day 6: 75 mg, Day 8: 100 mg.Day 10: 150 mg, Day 14: 300 mg. HCV RNA UL/ml was reduced from 780,000 to 644,000, Pretreatment Alkaline Phosphatase was 99, AST was 103 and ALT 195. Post treatment Alkaline Phosphatase was 88, AST 89 and ALT 127. An additional 250 mg ibogaine HCl reduced HCV RNA UL/ml to 154,000. Further testing showed continued reduction to HCV RNA UL/ml 78,200

Example. 4 A forty-two year old female testing positive for HCV RNA type 3. RNA IU/ml was 12,600,000. Subject was administered a total of 27 mg/kg ibogaine HCl in the following regimen:

6 x 2 mg/kg1 x 12 mg/kg1 x 3 mg/kg

HCV RNA IU/ml was reduced to 50,100. Prior to ibogaine treatment patient’s urine was dark and stool light. Post treatment color of urine and stool returned to normal.

ReviewPreliminary Examples Reporting

Reduction Viral Load by ibogaine

Subject Pre Post

3 780,000 78,200

4 12,600,00 50,100

Encouraging results

1. Repetitive low dosing with ibogaine provided continuous depression of viral load.

2. Genotype 3 appears highly responsive in keeping with results of interferon riboviron therapy.

3. Continued reduction in viral load after stopping of ibogaine therapy observed.

4. Less toxic than current HCV therapies.

Future development

1. Interest of pharmaceutical companies with experience in development of HCV drugs.

2. Preclinical confirmation of efficacy if possible.

3. Phase I/II clinical studies to confirm findings and establish preferred dose regimen.