Antineoplastons: Has the FDA kept its promise to the American people ?

FDA Commissioner’s comments

C-SPAN
Today

THE WHITE HOUSE
WASHINGTON

DAVID KESSLER
FDA COMISSIONER

CANCER DRUG TREATMENT APPROVAL PROCESS

March 29, 1996

4:17 – 6:17

We will eliminate unnecessary paperwork … that used to delay or discourage … cancer research … by non-commercial clinical investigators

I’d be happy to take a few questions

QUESTION:

Yes I … Will uhh … FDA’s initiatives …
that you announced today expedite the current review of antineoplastons … treatments

ANSWER:

The … FDA’s initiatives … will allow …
the agency … to rely on smaller trials … fewer patients … if there is evidence … of partial response in clinical trials

I don’t want to get into any particular … agent … except let me point out … that … the information needs to be part … of clinical trials

We will accept … less information … up front – we’re going to require further study AFTER … approval … because the science … has matured

The important – point … is that information needs to be gathered … through scientific means … through clinical – trials … and I think – that’s … that’s very important uhh very … important point

You can’t … just … use an agent here – or there … you have to use it … as part of a clinical trial … so we can get information … on whether the drug works

QUESTION:

Will will patients uhh who have taken other forms of of … of cancer treat – treatments; chemo or radiation treatments … uhh be allowed to participate for trials of antineoplastons

ANSWER:

The uhh agency has … many … trials … has has approved trials … for patients … with antineoplastons

We are committed to providing expanded access … availability … for American patients for any drug … there’s reason to believe … may work

6:17

2003 – 2007 Phase II preliminary

2003 – Phase II
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
recurrent diffuse intrinsic brain stem glioma
Phase 2
phase II
antineoplaston A10 and AS2-1

6 months median duration of treatment

of all 12 patients
2 years / 33.3% – Survival
2 / 17% – alive and tumour free for over 5 years since initial diagnosis

from the start of treatment
5 years – 1 alive for more than
4 years – 1 alive for more than

Only mild and moderate toxicities were observed, which included

3 cases of skin allergy

2 cases of:
anaemia
fever
hypernatraemuia

single cases of:
agranulocytosis
hypoglycaemia
numbness
tiredness
myalgia
vomiting

2003
Protocol – recurrent diffuse intrinsic brain stem glioma
12 – Patients Accrued
10 – Evaluable Patients
2 / 20% – # and % of Patients Showing Complete Response
3 / 30% – # and % of Patients Showing Partial Response
3 / 30% – # and % of Patients Showing Stable Disease
2 / 20% – # and % of Patients Showing Progressive Disease

2004 – Phase II
http://www.ncbi.nlm.nih.gov/m/pubmed/15563234

Drugs R D. 2004;5(6):315-26

incurable recurrent and progressive multicentric glioma

antineoplaston A10 and AS2-1 (ANP)

9 – patients’ median age

6 patients were diagnosed with pilocytic astrocytoma

4 with low-grade astrocytoma
1 with astrocytoma grade 2

1 case of visual pathway glioma, a biopsy was not performed due to a dangerous location

16 months – The average duration of intravenous ANP therapy

19 months – The average duration of oral ANP

1 patient was non-evaluable due to only 4 weeks of ANP and lack of follow-up scans

1 patient who had stable disease discontinued ANP against medical advice and died 4.5 years later

10 patients are alive and well from 2 to >14 years post-diagnosis

Only 1 case of serious toxicity of reversible tinnitus, of 1 day’s duration, was described

2004
Protocol – incurable recurrent and progressive multicentric glioma
12 – Patients Accrued
– Evaluable Patients
33% – % of Patients Showing Complete Response
25% – % of Patients Showing Partial Response
33% – % of Patients Showing Stable Disease
0 / 0% – # and % of Patients Showing Progressive Disease

2005 – Phase II
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929

Integr Cancer Ther. 2005 Jun;4(2):168-77

13 children with recurrent disease or high risk

6 (46%) survived more than 5 years

2005
Protocol – recurrent disease or
high risk
– Patients Accrued
– Evaluable Patients
23% – % of Patients Showing Complete Response
8% – % of Patients Showing Partial Response
31% – % of Patients Showing Stable Disease
38% – % of Patients Showing Progressive Disease

2006 – Phase II
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713

Integr Cancer Ther. 2006 Mar;5(1):40-7

Brainstem glioma carries the worst prognosis of all malignancies of the brain

Most patients with brainstem glioma fail standard radiation therapy and chemotherapy and do not survive longer than 2 years

Treatment is even more challenging when an inoperable tumor is of high-grade pathology (HBSG)

patients with inoperable tumor of high-grade pathology (HBSG) treated with antineoplastons in 4 phase 2 trials

39% – overall survival at 2 years
22% – overall survival at 5 years

17+ years maximum survival for a patient with anaplastic astrocytoma

5+ years for a patient with glioblastoma

39% – Progression-free survival at 6 months

5+ year survival in recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of the brainstem in a small group of patients

18 – evaluable
4 – glioblastomas
14 – anaplastic HBSG

14 – diffuse intrinsic tumors
12 – recurrence
6 – did not have radiation therapy or chemotherapy

Antineoplastons, A10 (A10I) and AS2-1 injections

5 months median duration

Responses were assessed by gadolinium-enhanced magnetic resonance imaging and positron emission tomography

Antineoplastons tolerated very well
1 case of grade 4 toxicity (reversible anemia)

2006
Protocol – high-grade pathology (HBSG)
– Patients Accrued
18 – Evaluable Patients
11% – % of Patients Showing Complete Response
11% – % of Patients Showing Partial Response
39% – % of Patients Showing Stable Disease
39% – % of Patients Showing Progressive Disease

FDA Commissioner David Kessler

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