Ibogaine in the treatment ofchronic hepatitis C

Howard S. Lotsof.President

Dora Weiner FoundationStaten Island, NY

http://www.doraweiner.org

2007 InternationalDrug Policy Reform Conference

New Orleans, LAFriday, December 7Astor Crown Plaza

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 chronic blood borne viralInfection 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 effect 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

• Individual contacts via the Internet

Ibogaine activists and 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 ibogaine 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..

An additional 250 mg ibogaine

Review Example 3

Status V.load ALP AST

ALT Date

Baseline 2,330,000

79 75 133 11/02

Data point

780,000 84 52 77 2/03

Ibogaine 644,000 79 75 170 1/04

Ibogaine 154,000 58 69 170 2/06

Data point

78,200 71 52 109 10/06

A.E. 1,240,000

76 100

206 9/07

Data point

N/A 78 41 89 11/07

Data point

? ? ? ? ?

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.

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 until adverse event with celebrex.

4. Less toxic than current HCV therapies.

Problems

1. Failure of ibogaine providers to track HCV viral load and liver enzyme levels in patients

2. Costs of testing that are prohibitive to patients

3. Failure of patients and providers to understand the importance of HCV and liver enzyme data collection

Future development

1. Ibogaine providers and patients to take greater interest in data collection.

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

3. Preclinical confirmation of efficacy if possible.

4. Phase I/II clinical studies to confirm findings and establish preferred dose regimen. Studies most likely to be included in research of ibogaine’s effects on opioid withdrawal in studies now discussed for Israel and India.

Thanksto

Patients and Ibogaine Activists that have given us

an early look intothese promising data