Ibogaine in the treatment of chronic hepatitis C

Howard S. Lotsof. President Dora Weiner Foundation Staten Island, NY http://www.doraweiner.org

Invitational Ibogaine forum Warsaw 2007 Wednesday 16 May Hotel Sofitel Victoria

Tabernanthe iboga
source of ibogaine

Found in West African rain forests

Purified Ibogaine HCl

Courtesy Jason Callan President and Founder Ethnogarden Botanical www.ethnogarden.com

Ibogaine HCl pharmaceutical grade

99.4% purity

Hepatitis C (HCV) timeline

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

HCV infection
Most common viral infection in the United States New infections per year 1990 - 242,000 New infections per year 2001 - 25,000 New infections per year 2004 - 25,000 Greater than 75% of IVDUs test positive

Science follows patent development

1. The discovery of ibogaines 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.

Ibogaine Patents
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 polydrug dependency syndromes, US 5, 124,994 (1992)

Research follows skepticism

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

Opioids

Cocaine

Alcohol

Nicotine

Ibogaine activist organizations play role in ibogaine HCV research

International Coalition for Addict SelfHelp (ICASH) 1989 Dutch Addict Self-Help (DASH) 1990 Ibogaine Underground 2004

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
ALT AST GGT

Pre
410 201 155

Post
50 25 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/kg 1 x 12 mg/kg 1 x 3 mg/kg HCV RNA IU/ml was reduced to 50,100. Prior to ibogaine treatment patients urine was dark and stool light. Post treatment color of urine and stool returned to normal.

Review Preliminary Examples Reporting Reduction Viral Load by ibogaine

Subject 3 Pre 780,000 Post 78,200

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.