9/02 Update on Trials w/Antineoplastons

Once again the best results in treatment of brain cancers was reoported by Dr.Burzynski. The latest results received September,2000 from Dr.Burzynski’s clinical trials reported the following updated Results:

His antineoplastons are in FDA sanctioned clinical trials for varying cancers. Website www.cancermed.com you can link to a patient group that did well on the treatment at www.burzynskipatientgroup.org.

All of the reported results deal with Brain cancers.

The detailed protocols for each of the clinical trials is on his website www.cancermed.com

click on the 72 FDA supervised clinical trials.

The latest report of FDA supervised Phase 2 clinical Trials of Antineoplastons A10 and AS2-1 included 35 evaluable patients diagnosed with glioblastoma multiforme(39% of patients),anaplastic glioma(36%),low grade glioma (14%),PNET(8%) and malignant meningioma (3%).

In the CAN-1 results of 35 evaluable patients of 43 results improved slightly some movement from partial response to complete response

Complete Response-CR 25.7%

Partial Response-PR 22.9

Stable Disease-SD 31.4

Objective ResponseCR+PR 48.6

Positive Resp CR+PR+SD 80

Progressive Disease 20

Patients not admitted to CAN-1 results of 11 evaluable of 23

Complete Response-CR 27

Partial Response-PR 0

Stable Disease-SD 46

Objective ResponseCR+PR 27

Positive RespCR+PR+SD 73

Progressiv Disease 27

BT-3 Astrocytoma in 20 Patients

Complete ResponseCR 20

Partial ResponsePR 10

Stable DiseaseSD 50

Objective ResponseCR+PR 30

Positiv Resp CR+PR+SD 80

Progressive Disease 20

BT-3 High Grade Glioma in 12 Patients

Complete ResponseCR 16.7

Partial ResponsePR 16.7

Stable DiseaseSD 33.3

Objective ResponseCR+PR 33.4

Positive RespCR+PR+SD 66.7

Progressive Disease 33.3

BT-9 Primary Brain Tumors in 11 evaluable of 17 patients improved moving slightly from partial response to complete response.

Complete ResponseCR 9.1

Partial ResponsePR 45.5

Stable DiseaseSD 36.4

Objective ResponseCR+PR 54.6

Positive Response 91

Progressive Disease 9

BT-11 Brain Stem Glioma in 18 evaluable of 23 Patients improved slightly with movement from partial response up to complete and from stable disease to partial response

Complete ResponseCR 16.7

Partial ResponsePR 22.2

Stable DiseaseSD 27.8

Objective ResponseCR+PR 38.9

Positive ResponseCR+PR+SD 66.7

Progressive Disease 33.3

BT-13 Children with low grade Astrocytoma in 8 evaluable of 9 patients there was slight improvement moving from stable disease partial response

Complete ResponseCR 25

Partial ResponsePR 37.5

Stable Disease 25

Objective ResponseCR+PR 62.5

Positive RespCR+PR+SD 87.5

Progressive Disease 12.5

B-18 Mixed Glioma in 11 evaluable of 14 patients

Complete ResponseCR 27.3

Partial ResponsePR 9.1

Stable DiseaseSD 18.2

Objective ResponseCR+PR 36.4

Positive RespCR+PR+SD 54.6

Progressive Disease 45.4

Medullablastoma (PNET) in 12 children under 2 protocols

Objective ResponseCR+ PR 33.3

Stable DiseaseSD 33.3

Positive Response 66.6

Progressive Disease 33.3

Some of these patients classified stable disease continue to take antineoplastons had tumor decreases and are approaching partial response.

The one year survival rate on antineoplastons in these medullablastoma trials is 92%

The two year survival rate is 75%

Most Patients (7) in this trial did not receive standard therapy; in these cases they received antineoplastons after surgery.These patients had a 3 year survival rate of 86%.

The survival rate of patients receiving only surgery is 0 to 12% after 1 year and 0% after 2 years.

The above response rates were categorized as defined by the National Cancer Institute definitions as follows:

Complete Response required complete disappearance of all content-enhanced tumor(s) on imaging studies for 4 weeks or longer.

Partial Response required more than 50% reduction in the sum of the products of the greatest perpendicular diameters in contrast enhanced tumor(s) for at least 4 weeks.

Stable Disease required less than 50% change(either greater or smaller) in the sum of the product of the greatest perpendicular diameters of the contrast enhanced tumor(s) for at least 12 weeks.

Progressive Disease was greater than 50% increase in the sum of the products of the greatest perpendicular diameters of the contrast enhanced tumor(s)compared with the nadir evaluation or appearance of new lesions.

In the CAN-1 trial, the oldest trial, median time to disease progression was 16 months from first day of treatment. Median Time of survival was 27 months from first day of treatment and median time of survival from diagnosis is 4 years. Of the 43 patients(including those non-evaluable) in the CAN-1 trial 16 patients are alive and responding to antineoplastons for an average survival of 4 years.

Antineoplastons will be submitted to the FDA for approval as a new prescription drug later this year. Currently they are only available in clinical trials.

Since it is considered experimental insurance and HMO’s usually will not pay for it up front although some people have received settlements after they rcovered and claimed reimbursement.

Thanks to Arnold Gore (New York State) for passing this information along

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