Transcript Document

Ibogaine in the treatment of chronic hepatitis C

Howard S. Lotsof.

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

2007 International Drug Policy Reform Conference New Orleans, LA Friday, December 7 Astor Crown Plaza

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 chronic blood borne 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 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.

Ibogaine Patents

1.

2.

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4.

5.

Rapid method for interrupting the narcotic addiction syndrome, US 4,499,096 (1985) Rapid method for interrupting the cocaine and amphetamine abuse syndrome US 4,587,243 (1986) Rapid method for attenuating the alcohol dependency syndrome, US 4,957,523 (1989) Rapid method for interrupting or attenuating the nicotine/tobacco dependency syndrome, US 5,026,697 (1991) Rapid method for interrupting or attenuating poly drug 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 effect have been confirmed by research a) Opioids, b) stimulants, c) Alcohol d) nicotine

Opioids

Cocaine

Alcohol

Nicotine

Ibogaine activists and organizations play role in ibogaine HCV research

• • • •

International Coalition for Addict Self Help (ICASH) 1989 Dutch Addict Self-Help (DASH) 1990 Ibogaine Underground 2004 Individual contacts via the Internet

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 AST GGT 410 201 155 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 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 Baseline V.load

2,330,000 Data point 780,000 Ibogaine 644,000 Ibogaine 154,000 Data point 78,200 A.E. 1,240,000 Data point N/A Data point ?

ALP AST ALT 79 75 133 84 79 58 71 76 78 ?

52 75 69 52 77 170 170 109 100 206 41 89 ?

?

Date 11/02 2/03 1/04 2/06 10/06 9/07 11/07 ?

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 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.

Thanks to Patients and Ibogaine Activists that have given us an early look into these promising data