Much attention has been focused on Dr. Burzynski’s antineoplaston therapy for patients who are terminally ill, and rightly so. However, the general public and most of Dr. Burzynski’s patients know little about the inner workings of the clinic, the manufacturing facility, the research institute, and the highly skilled professionals who work behind the scenes at both sites.

At the Clinic itself, located in Houston, Texas, patients are cared for and clinical trials are performed. The Burzynski Research Institute is located a short drive from the Clinic. There, antineoplastons are manufactured and research is ongoing. Before providing a glimpse behind the scenes at the S.R. Burzynski Clinic and the Burzynski Research Institute, here are a few words on...

...HOW ANTINEOPLASTONS WORK

Antineoplastons are nontoxic, naturally occurring peptides, amino acid derivatives, and organic acids that fight cancer with few if any side effects. Traditional radiation therapy and chemotherapies poison cancer cells and healthy cells as well; antineoplastons cause no harm to healthy cells. Although the detailed mechanism by which antineoplastons work is unknown, they may act as biochemical microswitches to turn off the genes that cause cancer, called oncogenes, and activate the genes that fight cancer, called tumor suppressor genes.

Because these drugs are harmless to healthy cells the body can be flooded with antineoplastons, and only cancer cells are affected. Patients typically carry a small pump that delivers antineoplastons directly into the bloodstream at regular intervals. Some patients take capsules orally.

In addition to two clinical trials completed before, recently FDA approved clinical trials have reached end point and have shown particularly encouraging results in malignant brain tumors. Of 226 brain-tumor patients treated, 29.2% showed a dramatic response (complete disappearance or more than 50% shrinkage of tumor), 35.8% showed stabilization, and only 35% had tumor growth. Most of these patients had failed chemotherapy and radiation, and had no conventional treatment options remaining. Encouraging results are also documented in non Hodgkin's Lymphoma.

Researchers at Kurume University in Japan are conducting two clinical trials on antineoplastons in the treatment of colon cancer and primary liver cancer, which are major killers in that country. These researchers already have reported successful outcomes in both types of cancer.

AT THE S.R. BURZYNSKI CLINIC...

At the S.R. Burzynski Clinic, clinical trials are underway for many types of cancer. Care and evaluation of patients participating in these trials are provided by the departments of medicine and radiology. In addition, the FDA requires extensive documentation of patient data and strict adherence to FDA rules and regulations. At the S.R. Burzynski Clinic, the Section of Quality Assurance, Archives Department, Department of Medical Records and Documentation, Section of Clinical Trial Documentation, and Computer System Department ensure that the trials conform to FDA standards. Here is a brief overview of what is being done at the Clinic.

DEPARTMENT OF MEDICINE

The Department of Medicine employs approximately 37 people. Dr. Burzynski is the head of the department. Three senior physicians report directly to Dr. Burzynski and are aided by 16 research associates, who are physicians. Two physicians comprise the Department of Radiology. The Department of Medicine also employs IV and monitoring nurses, medical assistants, medical technicians, pharmacists, a person who oversees the IV supplies, and a nutritionist. As head of the department, Dr. Burzynski is responsible for the overall care and treatment of patients. The senior physicians are responsible for the day-to-day treatment of patients under his supervision. The research associates have extensive contact with patients and report to the senior physician. The nurses are responsible for the daily care of patients and treatment follow-up.

DEPARTMENT OF RADIOLOGY

The radiologist at the S.R. Burzynski Clinic is responsible for evaluating and maintaining patients’ radiologic files. To determine the efficacy of antineoplastons, tumor measurements are determined before, during, and after treatment with these drugs. Tumor measurements are entered into a state-of-the-art information system that allows for compilation into written reports as required by the FDA.

The Department of Radiology also is responsible for preparing films for review by independent radiologists and for presenting patient histories and films at medical conferences and before the media and consulting groups.

SECTION OF QUALITY ASSURANCE

The Section of Quality Assurance is responsible for the following:

Monitoring each study to ensure that the facilities, equipment, personnel, methods, practices, records, and controls are in compliance with government regulations

Overseeing the function and performance of the archivist and archives

Overseeing the use, calibration, maintenance, and repair of all instruments, along with the documentation of such

Ensuring that personnel are trained regularly and that training is sufficiently documented

DEPARTMENT OF MEDICAL RECORDS AND DOCUMENTATION

The Department of Medical Records and Documentation sees to it that raw data from the clinical trials are collected and stored. The head of the department also oversees the preparation of

Weekly and monthly reports for the FDA

Annual reports for the FDA

Special exceptions to the FDA protocols

The protocols themselves and any amendments

Together with the Section of Clinical Trials Documentation, the Department of Medical Records and Documentation documents the collection, manipulation, and storage of raw data for the clinical studies to show the safety and efficacy of antineoplastons in the treatment of different types of cancer.

FDA REGULATIONS

The Chief Regulatory Officer (CRO) has many responsibilities at the S.R. Burzynski Clinic. Some of the major ones are the following. He

Provides regulatory advice

Documents the structural organization and FDA requirements for nonclinical and clinical studies

Supervises compliance with regulations of the Clinic and the Burzynski Research Institute

Submits the weekly, monthly, and annual reports for the FDA to the Institutional Review Board

Currently is in the process of preparing approximately 1,400 standard operating procedures

Oversees the manufacturing facility’s compliance with FDA regulations

Interfaces with FDA officials and meets with examiners from various regulatory agencies

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Dr. Olgierd Peter Kaltenberg, the Chief Regulatory Officer, holds a doctorate in chemistry and a Master’s of Science degree in chemical engineering. As a postdoctoral fellow, he conducted research at the Department of Chemistry at Rice University in Houston, Texas. Dr. Kaltenberg was involved with the formation of the Burzynski Research Laboratories, later named the Burzynski Research Institute. In particular, from 1977 to 1982, Dr. Kaltenberg was involved in the initial development of the pilot plant and production-scale installations for manufacture of antineoplastons; and he investigated the synthesis of Antineoplaston A10.

AT THE MANUFACTURING PLANT...

Antineoplastons are made at a pharmaceutical plant specifically designed and built for their manufacture in a facility that measures 46,000 square feet. The plant has been in operation since 1983 and has been updated throughout the years. In 1997, the production level of active ingredients reached 24 metric tons, which corresponds to 80,000 liters of final drug product. Thirty-eight employees work in analytical chemistry, microbiology, chemical technology, quality assurance, manufacturing, engineering, administration, maintenance, and purchasing.

Three basic steps are involved in the complex manufacturing operation: synthesis of intermediate products, preparation of the drug substance, and manufacture of the drug product in the finished dosage form. The last step includes product sterilization, filling, sealing, labeling, and packaging the IV bags.

The design and operation of the manufacturing facility and the production and control procedures must be in compliance with all engineering codes and strict government rules and regulations. Therefore, exceptionally qualified and open-minded engineers, chemists, and scientists are hired. This dedicated staff has a broad range of education, training, and experience.

The engineers handle multidisciplinary projects that require knowledge of various types of engineering: chemical, mechanical, environmental, electrical, and instrumentation and controls. The engineers ensure that manufacturing equipment, installations, and process controls are in compliance with engineering codes and environmental and OSHA regulations. The FDA, National Cancer Institute, and independent consultants have verified that the manufacturing plant is in compliance with cGMP and cGLP.

The chemists and scientists are responsible for chemical and microbiological testing. Quality control procedures consist of analytical chemistry testing of raw materials, intermediate products, drug substances, and final drug products. Microbiological testing is performed on the drug substances, drug products, purified water, and water for injections. Environmental testing also is performed to monitor microbial quality of all production areas used for drug substance and drug product processing.

Antineoplaston manufacture must meet government standards for the pharmaceutical industry. The FDA has thoroughly reviewed and approved the specifications for intermediate products, drug substances, and drug products in finished dosage forms, as well as quality control methods and procedures.

At the pharmaceutical plant, it is policy to exceed industry standards whenever possible. For example, as a direct result of very strict maintenance, sanitation, and control procedures, the purified water system constantly produces purified water with zero bioburden compared with the FDA recommended limit of 10,000 colony-forming units/100 mL. The dry heat and steam sterilization cycles also have safety factors much higher than those recommended.

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Kris Wisniewski, the Plant Manager and Director of Regulatory Affairs, has been with Dr. Burzynski since 1983. He holds master and bachelor of science degrees in electrical engineering and has completed postgraduate courses in analog and digital control systems. Mr. Wisniewski engineered, designed, and oversaw construction of the manufacturing facilities. He manages the complex pharmaceutical manufacturing process and ensures that the plant conforms to all codes and regulations. He is the designated company representative for hosting plant inspections conducted by federal, state, and local authorities.

AT THE BURZYNSKI RESEARCH INSTITUTE...

The Department of Molecular and Cellular Biology at the Burzynski Research Institute has three major goals:

The first goal is to screen newly isolated or synthesized compounds for anticancer activity

The second is to work to understand the detailed mechanism of action of antineoplastons

The third goal is to increase the effectiveness of antineoplastons

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NOTE: This document provides general information about the S.R. Burzynski Clinic, the manufacturing facility, and the Burzynski Research Institute and is not meant to describe all departments and their functions required by government regulations.