ANTINEOPLASTON INFORMATION

Antineoplastons:
Two components:
Atengenal (Antineoplaston A10, " Bag 1" or "A bag" ) and Astugenal (Antineoplaston AS2-1, "Bag
2" or "B bag"):

Atengenal (Antineoplaston A10) composition:
A synthetically derived sterile solution in a 4:1 ratio of sodium phenylacetylglutaminate and
sodium phenylacetylisoglutaminate.

Atengenal (Antineoplaston A10) mechanism of action:
It is believed, from laboratory studies, that Astugenal (A10) inhibits the production of proteins in
cancer cells, which is necessary for continued life and function of the cancer cells (by inhibiting
incorporation of the amino acid glutamine in the production of proteins). 1

Astugenal (Antineoplaston AS2-1) composition:
A synthetically derived sterile solution in a 4:1 ratio of sodium phenylacetate and
phenylacetylglutaminate.

Astugenal (Antineoplaston AS2-1) mechanism of action:
Cancer results from the increased activity of oncogenes (cancer genes) and the decreased expression of
tumor suppressor genes (genes that decrease or halt cancer). It is believed, from laboratory studies, that
AS2-1 modulates the expression of the ras oncogene (subsequently causing reduction of the
multiplication of cancer cells) and the tumor suppressor gene p53 causing cancer cell death. 2

Antineoplaston infusion:
Antineoplastons are infused intravenously every 4 hours (6 times a day) because they are broken down
quickly in the body and after 4 hours there is a significantly decreased therapeutic level of
antineoplastons remaining in the body.
Atengenal (A10) - On day one of treatment, an initial test dose of Atengenal (A10) will be given
followed by a starting dose 5 times that day for a total of 6 doses daily. In adults, we will increase the
dose every day (as tolerated), initially by 40 milliliter increments 6 times per day until we reach 200
milliliters 6 times per day, then by 20-milliliter increments 6 times per day until the maintenance dose
is reached. In children <12 years old, we will increase the dose every day in 10-milliliter increments 6
times per day, >12-18 years old we will increase the dose in 20-40 milliliter increments 6 times per
day until the maintenance dose is reached.
Astugenal (AS2-1) - On day one of treatment, an initial test dose of Astugenal (AS2-1)will be given.
In adults, we will increase the dose every few days (as tolerated), by 10-milliliter increments 6 times
per day until the maintenance dose is reached. In children < 12 years old, we will increase the dose
every few days in 5-milliliter increments 6 times per day, >12-18 years old we will increase the dose in
5-10milliliter increments 6 times per day until the maintenance dose is reached.

Pump for infusion of antineoplastons:
A portable programmable pump infuses antineoplastons intravenously automatically. Initially, the
pump will be running continuously (with a slow rate of fluid infusion after the antineoplaston infusion
is complete) to keep the central venous catheter line (or port) open and keep it from clotting. You will
be taught by our intravenous (IV) nurses how to prepare the antineoplaston bags, how to program the
mini pump, and how to troubleshoot problems related to the pump. Our nurses are very knowledgeable
concerning the infusion pumps; therefore, please address any questions or problems related to the
pump to the intravenous nurses in I.V. suites 235 or 236 or after hours via our answering service to the
nurse on call.
Page 1 of 13

Antineoplaston maintenance dose:
The maintenance dose of antineoplastons (the dose that the patient will eventually remain on) is based
on the patient's weight and is different for each patient. The maintenance dose will probably not be
reached before you leave Houston. The dose of antineoplastons will continue to be increased at home
until the maintenance dose is reached (which your doctor will calculate). Please note that the calculated
effective maintenance doses are averages and since all patients are different, your tumor may respond
to a higher or lower dose of antineoplastons than other patients.

Antineoplaston Shipping:
The shipping of antineoplastons should be at a controlled temperature within the storage range (15-30
degrees Celsius or 59-86 degrees Fahrenheit). Antineoplastons should be visually inspected
immediately before each use. If the solution appears cloudy or discolored, it should not be used but
returned to us immediately for analysis. We ship antineoplastons all over the world so there should be
no problem for you to get antineoplastons at your home. We ship a 15-day supply at a time due to the
large amount of medicine and the weight as well as necessity to keep the medicine from expiring
before it can be used. At discharge, you will receive a 15-day supply of medicine (unless you express
otherwise due to traveling size and weight constraints). You will pick up your initial discharge
antineoplaston medication supply with a written prescription given to you at discharge on the first floor
in suite 125 (take a right as you exit the elevator and this suite is located in the first door on your left).
Please let Jerzy know if you would like to take a smaller supply than prescribed home and he can ship
the remaining 15-day supply. We use Federal Express and routinely ship antineoplastons via regular
service, which typically arrives in 3 business days (at no cost to the patient). However, we can ship
antineoplastons via priority or overnight service, which should arrive the same day or the next day
respectively (with a shipping charge billed to the patient) which should not be necessary if an accurate
drug inventory is kept. Also, there is no one available in our shipping department on weekends or
holidays, so let us know in advance when you are getting low on your antineoplastons so we can ship
them out during the week.

Antineoplaston Storage:
Antineoplastons should be stored at room temperature (15-30 degrees Celsius or 59-86 degrees
Fahrenheit) without refrigeration or freezing.

Antineoplaston Inventory:
Once you return home, you will be asked to keep an accurate daily count of your antineoplaston supply
(drug inventory). This is very important so you don't run out of medicine as well as a cross check to
make sure you are taking the proper prescribed dose of antineoplastons (and not under or overdosing
antineoplastons thereby jeopardizing your health). ALWAYS note the expiration date on the
antineoplaston bags. DO NOT use expired antineoplastons.

Special or Compassionate Exception (CE):
Patients who do not meet the regular protocol criteria to participate in our clinical studies can be
granted a special or compassionate exception by the:
Institutional Review Board (IRB)
9432 Old Katy Road Suite 370
Houston, Texas 77055
713-365-0222
This board is a separate entity from the Burzynski Research Institute. Please note that it usually takes
at least 24 - 48 hours for the board to review and grant provisional approval for patients to start
antineoplastons. The full board will review the compassionate exception at their next meeting to
discuss final approval.
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
Food and Drug Administration (FDA) Approval:
Patients with extenuating circumstances (above and beyond those for special or compassionate
exception) that make them ineligible to participate in our regular protocols must receive approval from
the FDA and IRB to be eligible to participate in our clinical studies. Please note that this usually takes
24 - 48 hours for FDA approval AND an ADDITIONAL 24 - 48 hours for IRB approval.
Central Venous Catheter Placement:
A subclavian central venous (Hickman single lumen) catheter (a catheter in the vein of the upper part
of the chest just below the clavicle or collar bone) will be inserted prior to starting antineoplastons so
that we can infuse antineoplastons intravenously or through a vein.
Dr Stenoien (Dr Lee in his absence) at Houston Medical Imaging (see page 6 for address and phone #)
will perform this as an outpatient in their office with a local anesthetic (numbing) of the chest. We will
provide you with a map to their office. It is normal for the first 1 to 2 weeks while the catheter is
healing for the area around the catheter to be slightly tender to touch, painful, red , warm or with some
clear to bloody discharge. After the first 1 to 2 weeks when the catheter is healed, these can be signs of
infection and must be attended to immediately. Therefore, if you notice any of these problems, notify
your doctor immediately and he/she will start antibiotics to prevent or treat an infection. Wellmaintained central venous catheters or ports can remain in place for years, if necessary, without
infection. We will remove your suture or stitch in our office approximately 1 week after the catheter
was inserted.

Dressing changes, flushing, disconnecting, and reconnecting and medication administration via
the catheter:
The nurses will teach you how to do central venous catheter dressing changes every 3 days. It is very
important to keep the catheter clean and dry and use sterile technique while changing the catheter
dressing, flushing, disconnecting and reconnecting, and administering medications. This is a catheter in
the vein; therefore, a patient who has an immune system that is weakened by cancer can get an
overwhelming and sometimes fatal infection via the central venous catheter or port. After you are
comfortable with sterile flushing, disconnecting, and reconnecting the central venous catheter (or port),
you may disconnect the patient from the pump and reconnect just prior to the next scheduled infusion
of antineoplastons. This will give the patient some freedom from lugging the pump around
continuously. Please note that this will be approximately 1 week after start of treatment. Also, the time
disconnected will become less as the antineoplaston dose is increased since the antineoplaston infusion
time will be longer.

Blood work:
Blood work will be drawn prior to antineoplaston treatment (as baseline) and every other day after
starting treatment (through the catheter so you won't need to be poked). This is to determine any
potential problems before you even experience any symptoms. (For example, you may be required to
take supplemental oral potassium if your potassium level in your blood becomes low.) Blood work will
be drawn at home after discharge every other day while the dose of antineoplastons is being increased,
then 3 times per week (Mondays, Wednesdays, and Fridays) when the maintenance dose of
antineoplastons is reached. The frequency of blood drawing will be reduced to twice weekly once you
are clinically stable and have been on a stable dose of antineoplastons for at least 60 days. For your
safety, it is imperative that your blood work be faxed to us the same day it is drawn, so we can make
any necessary changes in your medications as soon as possible.
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
Contraception:
Since we do not know (at this time) the effects of antineoplastons on pregnant women or unborn
children, it will be necessary for potentially fertile women who are currently menstruating or have
not had a hysterectomy or completed menopause to use contraception to prevent pregnancy while
receiving antineoplastons. Contraception can be by injection, pills, or use of condoms. Men
receiving antineoplastons who have not had vasectomy must use condoms during intercourse at all
times. These requirements must be adhered to the entire time the patient is participating in the
study.
Please note that there MAY BE NO ill effects of antineoplastons on pregnant women or unborn
children, but this information is unknown at present. Therefore, this is a precaution to protect you
and potential unborn children.

Medications:
We will maintain a record of all prescription medications (including milligram dosage and
frequency taken per day) while you are enrolled in our study. Please bring all your prescription
medications to our office for your initial office consultation. This will help in the prevention of
drug interactions and accidental overdosing and underdosing.
1) Steroids:
As tumor cells die, there will be increased swelling or edema in the brain and around the tumor due to
your body sending in cells to clean up and remove the dead tumor. We try to prevent and offset this
swelling by starting or increasing the dose of, if you are already taking, an oral steroid such as
Decadron or dexamethasone at the beginning of treatment. This prevents symptoms of increased
swelling or edema such as seizures, headaches, nausea, vomiting, visual changes, etc. During the
course of your treatment, it may be necessary to switch the oral form of Decadron to the IV form. The
IV nurses will teach you how to administer IV Decadron via the subclavian catheter. Decadron can
also cause some irritation of the stomach in some patients; therefore, we will also start a medicine to
protect the stomach from irritation (Zantac, Pepcid, Tagamet, Axid, Prevacid, Aciphex, Nexium, or
Prilosec).
2) Anticonvulsants:
Most patients with brain tumors have seizures due to increased pressure on the brain; however, some
patients do not. If you are already on anticonvulsant(s)[anti-seizure medication(s)] prior to treatment
with antineoplastons, then we will continue your anticonvulsant(s) during the entire course of the
treatment. We anticipate that as we increase the dose of antineoplastons, the anticonvulsant
level(s) will drop. During administration of antineoplastons, there is increased elimination of urine
which may result in losses of anticonvulsants through the kidneys, resulting in a lower level of
anticonvulsant(s) in the blood with a higher risk of seizure(s). We will be monitoring your
anticonvulsant level(s) in your blood and probably increasing the dose of the anticonvulsant(s), as we
increase the dose of antineoplastons.

Supplements:
We will maintain a record of all nonprescription medications including over-the-counter
medications, supplements, herbs, vitamins, etc. (including milligram dosage and frequency taken
per day) while you are enrolled in our study. Please bring all your nonprescription medications to
our office for your initial office consultation. This will help in the prevention of drug interactions,
and accidental overdosing and underdosing.

Vitamin B12 and Folate (Folic acid):
Vitamin B12 and folate may promote cancer growth; therefore, if you are taking a multivitamin
which contains B12 and folate, we will obtain a B12 and folate level via a blood test and if these
levels are high, we will ask you to stop your multivitamin. If these levels are normal, you may
continue your multivitamin.
Page 4 of 13

Fluid Input and Output:
You will be required to maintain a record of your fluid intake (to include your I.V. antineoplaston
infusions) and urine output daily while you are increasing the dose of antineoplastons. The
purpose of this is to prevent dehydration and edema or swelling. The goal is to take in a slightly
greater fluid amount than you put out to prevent dehydration. However, taking in too much fluid
compared to your urinary output, will result in edema or swelling. As you can see, there is a
balance here. You will be taking in more fluids each day while you are increasing the dose of
antineoplastons (from an increased volume of fluid as the dose of antineoplastons is increased) as
well as drinking more fluids due to increased thirst. You will also be urinating more due to
drinking a larger volume of fluids and also due to a " diuretic effect " (increased fluid output) of
the antineoplastons. Your body will get used to the increased amount of fluid intake over a few
week period. If urinary output becomes overwhelming, you may consider having a urinary
catheter placed.

Urinary Catheters:
Urinary catheters can be placed (in our office) if urinary output becomes overwhelming. The
placement of a urinary catheter increases the risk for a urinary tract infection (especially in
patients whose immune system is weakened by cancer); however, we are monitoring you daily for
symptoms of infection as well as doing a urinalysis frequently which can detect a urinary tract
infection early in patients who have no symptoms. Urinary catheters come in the form of
indwelling foley catheters which remains in the bladder with a portable bag or a leg bag and
condom catheters (for men only) which can be removed during the day and used only at night or
may also be used the entire day.

Time duration in Houston:
Adults are required to stay a minimum of 15 consecutive days and children are required to stay a
minimum of 21 consecutive days in Houston from and including the first day of treatment (not 15
days from the first consultation date). If the patient is clinically stable on the 15th or 21st day
respectively for adults and children, they will be seen for the last time in the clinic that day, and
may return home later in the day or that evening. If you are uncomfortable with any aspect of the
treatment, you are welcome to stay longer in Houston (as long as it takes for you to feel
comfortable with all aspects of the treatment).

Hospitalization:
Should hospitalization be necessary during your stay in Houston:
Adults or children older than 14 years will be referred to:
Memorial Hermann Memorial City Hospital
921 Gessner Road
Houston, Texas 77024
713-242-3000
under the care of:
Adeeba Akhtar M.D.
902 Frostwood Suite 246 (Medical Plaza 1)
Houston, Texas 77024
713-468-2358
Fax: 713-468-2595
Children less than 5 years old will be admitted to The Texas Children’s Hospital (in the Texas
Medical Center) 6621 Fannin Street Houston, TX 77004, 832-824-2300.
Page 5 of 13

Psychological Referrals:
We will be glad to refer you to a therapist/psychologist to help assist you in dealing with issues related
to a chronic disease or care giving

Pharmacies:
We use 4 local pharmacies primarily for your convenience but will be glad to use any pharmacy you
desire for your medication needs.
Southern Family Pharmacy
9432 Katy Freeway, Suite 277
Houston, Texas 77005
Pharmacist: Yvonne Remo R.Ph.
713-335-5640
CVS Pharmacy
9455 Hammerly (at Blalock)
Houston, Texas 77055
713-722-1490
Walgreen's Pharmacy
9329 Katy Freeway (I-10 @ Echo Lane)
Monday - Friday 9 AM - 10 PM
Saturday 9 AM - 6 PM
Sunday 10 AM - 6 PM
Location: Hedwig Village Shopping
Center next to Kroger
713-461-3607
For emergencies:
24 Hour Walgreens
Longpoint @ Bingle
713-468-7813
When you return home, we will be glad to call your medications to your local pharmacy.

Magnetic Resonance Imaging (MRI s):
Baseline MRIs and CTs in Houston will be done primarily at:
Houston Medical Imaging
7000 Fannin Suite M-40
Houston, Texas 77030
713-797-1919
Fax 713-383-9933
since they are the promptest at scheduling our patients. If your insurance will not pay for MRIs or CTs
done here or if you need to use another facility for any reason, we will be glad to accommodate you;
however, these scans may take longer to schedule at another facility. A map to the imaging facility will
be provided for your convenience. Most protocols require a follow up MRI or CT every 4 to 8 weeks
from start of treatment, initially. Your research associate will let you know the exact frequency of
scans required by your individual protocol. If you take your baseline (most recent) scans home with
you, you will need to send them back with your new scans for comparison. We will ALWAYS need
the previous (most recent) scans along with the current scans for comparison! Therefore, please have
the facility that does your scans send us both a written report and the actual scans for our review.
Page 6 of 13

Local doctor:
It is common sense for any patient who has a chronic disease, including cancer, to have a regular
established local doctor in case of emergencies. The FDA wants to ensure this, so they require that
your local doctor signs a form called the 1572 that states, in writing, that your doctor agrees to take
care of you at home. Let us know at the beginning of your treatment your doctor's name and address
and we will send them a packet of information about our treatment and the 1572 form. We must have
this signed 1572 form back prior to your departure from the clinic. We know your local doctors are
busy; therefore, we try to send these packets the first day of treatment so that your doctor will have
time to read, sign and send the 1572 back to us prior to your discharge. Your doctor can be as little or
as much involved with our study as they desire and we try to make everything as easy as possible on
them. Therefore, we will be giving you all orders for MRI and CT scans and blood work, interpreting
these, making changes in your medications, and calling in refills and other medications to your local
pharmacy. If you are a member of a PPO or HMO insurance in which your local doctor must order
your blood work and scans for insurance to pay, it will be necessary for your doctor to cosign our
orders. The minimal responsibility of your local doctor will be:
1) Perform a physical examination every 4 weeks. The physical examination must be documented on
a 1 page simple form that we will supply to the doctor. Your first physical examination at home is
required 4 weeks from your initial physical examination at our clinic (not 1-month from discharge).
2) Evaluate and treat any problems or symptoms that we cannot evaluate over the phone.

Doctors at the Burzynski Clinic:
There are several doctors who work with antineoplaston patients at our clinic:
S.R. Burzynski M.D., Ph.D. - Principal investigator
Robert A. Weaver M.D., C.P.I. - Co-Investigator, Certified Physician Investigator
Barbara Szymkowski M.D. - Research Associate
Sheryll Acelar M.D. - Research Associate
Alejandro Marquis M.D. – Senior Physician
Marek Walczak M.D. – Research Associate
Shah Alam M.D. - Research Associate
Eva Kubove M.D., C.C.R.C. - Research Associate, Certified Clinical Research Coordinator
Lourdes DeLeon M.D. – Research Associate
Tolib Rakhmanov M.D. - Research Associate
Dr. Weaver will perform your physical examinations and evaluate you every weekday while you
are in Houston, and supervise your care via the research associates once you return home. The
research associates will obtain your initial medical history, evaluate you on weekend days in
Houston,and once you return home, will call you to review blood tests, make medication changes, and
address any problems or symptoms. The same research associate who takes your initial medical history
will follow you the entire time you are participating in the study.

Radiology Consultation:
Mohammad Khan M.D. or Vsevolod (Sev) Dolgopolov M.D. will review your baseline MRIs or CT
scans with you and compare them to your most recent prior films (if available) in Suite 205 at the
beginning of your treatment.

Nurses:
o Clinical Research Coordinators (CRCs)/Monitor nurses:
Marilyn Threlkeld L.V.N., C.C.R.P. (Certified Clinical Research Professional)
will call you daily ( for patient safety) once you return home. They will ask questions concerning
new/continued symptoms or problems (adverse events), new medication or medication dosage
changes, and your antineoplaston supply. Please let them know what a convenient time will be for
them to call, and provide them with an alternate number when you will be away from home.
Page 7 of 13
o
Intravenous (I.V.) nurses (suites 235 or 236):
Cesar Diaz R.N.
Marlene Bestak R.N., B.S.N.
Juanita Brown R.N.
Ivette Ureste L.V.N.
o
Patient Support Group Coordinator/In-house nurse:
Marlene Bestak R.N., B.S.N.

Patient Support Group:
Marlene Bestak R.N., B.S.N. leads a Burzynski Clinic patient support group on Mondays from
5 - 6:30 PM in the library of our clinic (located down the hallway to the left of the waiting room).

Medical assistants:
Beata Rusak C.M.A.
Krystyna Dolomisiewicz C.N.A.,C.M.A
Amanda Loya M.A.

Dietary Consultation:
As part of your treatment, you will have a consultation with one of our dieticians, Donna J. Christoffel,
M.S., R.D. - nutritionist or Vickie Cambron R.N., usually within a few days of starting
antineoplastons. They will discuss a low sodium (Na) diet (usually 2 grams or 2000 milligrams per
day) due to the large sodium content of the antineoplaston solution, increased potassium (K) intake
since most patients tend to lose potassium due to Decadron, increased fluid intake, calorie
requirements, supplements, vitamins and other topics customized to each patient's medical history and
specific needs.

Financial Issues:
Please address all financial or insurance questions and issues to your assigned financial assistant:
Deborah Jurida 713-335-5613
Shirley Maneli 713-335-5608
Maggie Jordan 713-335-5623
Estela Rocha 713-335-5668

The Burzynski Breakthrough:
The Burzynski Breakthrough, written by Thomas D. Elias, is a book which recounts the trials and
tribulations of the Burzynski Clinic and antineoplastons and a story about hope in the fight against
cancer. It is available at our front desk.

Operating a motor vehicle:
Texas law prohibits a patient with seizures from operating a motor vehicle if they have had a seizure
within 6 months. We DO NOT recommend any patient with a brain tumor (even those who have never
had a seizure) operate a motor vehicle (car or airplane) because there is the potential of developing
dizziness or an initial seizure causing harm to themselves or others. Please review your local laws for
patients with seizures or brain tumors operating motor vehicles or the Federal Aviation Administration
(FAA) regulations regarding piloting an airplane.

Burzynski Clinic Address:
9432 Katy Freeway, Suite 200
Houston, Texas 77055
Page 8 of 13

Clinic Hours:
Monday - Friday: 9 AM - 5 PM
Saturdays, Sundays and holidays: 9 AM - until the last patient leaves the clinic

Appointments:
Appointments will be made for you at your convenience by our front desk staff between the hours
of 9 AM and 5 PM on weekdays and between the hours of 9 AM and 12 noon on weekends and
holidays. Our doctors try to spend as much time with you as you need; therefore, please try to be
on time for your appointment out of respect for other patients, so you don't intrude on other
patient's appointment times. Please be patient on weekends and holidays, since you may have to
wait slightly longer due to a reduced staff.

Burzynski Clinic fax number:
713-935-0649

Burzynski Clinic phone number/24-hour answering service:
713-335-5697
We have a 24-hour answering service to accommodate questions or problems. If you have a
medical question or problem after the clinic is closed, please call our main number above and ask
for the doctor on call for antineoplastons. One of the above research associates will call you back
and answer your questions and evaluate your problems. Please call with prescription and
antineoplaston refills on weekdays only, since the doctors on-call on the weekends and holidays
will be handling urgent calls. Our nurses are very knowledgeable concerning the infusion pumps;
therefore, please address any pump questions or problems to the nurse on call. We encourage you
to call early if you suspect a problem rather that delaying and having a minor problem turn into a
major one.

Security:
Monday through Saturday, you may enter the building via the front or rear entrances. For
Sundays, you must sign out a keycard from the receptionists on Fridays which will allow you to
enter the rear of the building by sliding your keycard through the machine located adjacent to the
rear doors. If this does not work, use the intercom system by pushing the button on the gray box
next to the door and the IV nurses will push a button that will allow you to open the rear door.
When leaving the building on Sundays, you can only exit via the rear doors. Push the green button
on the right wall next to the rear doors, which will allow you to exit. You must return your
keycard to the receptionists on Monday; otherwise, you will be charged to replace the card.

Parking:
Patients with handicap stickers on their vehicles may park in the marked handicap spaces reserved
in front of the building or on the first floor of the parking garage behind the building. Patients
without handicap stickers on their vehicles may park in any unreserved or nonhandicap spaces
surrounding the building or in the parking garage behind the building in any unreserved or
nonhandicap spaces (but not in the fire zone on the west side of the building). There is no charge
for parking.
Page 9 of 13

Signed Informed Consent for treatment:
Signed informed consent will be required prior to a patient starting a drug study protocol. This
simply means that the patient has read the consent form in their own language (interpreters
available upon request) and understands the risks and benefits of the drug study and knowingly
and voluntarily is participating in the study. If a patient is mentally incompetent to sign the
consent form or is younger than 18 years old, then an immediate family members such as a parent,
spouse, siblings or adult child older than 18 years old may sign the consent form. If the patient is a
minor (< 18 years old) but understands the concept of voluntarily participating in a research study
(usually 12 years old or older), he/she should sign the consent form to signify that he/she has
assented to participate in the study. If the patient is accompanied by a friend or relative who is not
one of the above mentioned individuals, then a medical (not financial) power-of-attorney form for
the patient will be required for this person to sign the consent form.

Compliance:
The FDA requires patients participating in drug studies to adhere and comply STRICTLY with
written drug study protocols to ensure patient safety. This includes doing physical examinations,
having blood work and scans as scheduled and taking the correct prescribed dose of medication.
Repercussions for NOT adhering to the protocol can be temporary or permanent suspension of the
study medication!

Orphan Drug Designation (ODD)
The FDA notified the Burzynski Research Institute on September 7, 2004 that it had granted its
petition for Orphan Drug Designation for Antineoplaston infusions for the treatment of brain stem
gliomas. This designation is the culmination of many years of dedicated effort and represents a
major milestone on the long road to market approval since many orphan products receive
expedited review from the FDA for market approval.
The FDA's orphan drug program encourages research, development and approval of products for
rare diseases and for drugs that provide a significant therapeutic advantage over existing
treatments. Orphan Drug Designation may be granted by the FDA for a drug which treats
conditions or diseases that affect less than 200,000 persons annually in the United States.
Since antineoplastons has not yet received market approval, insurance companies may not
reimburse for drug expenses; therefore, consult your insurance company for specific
reimbursement policies.

Discharge:
On the day of discharge, you will be given a discharge summary and monthly physical exam
forms for your local doctor, a 10 day supply of antineoplastons, written orders for your follow-up
scans and blood work, a letter informing airline personnel that you will have in your possession
study medication and supplies(including needles) and you will meet your assigned monitor nurse.
Please plan to spend an extra 1 - 1 1/2 hours in the clinic that day to complete these tasks.

Suggestions:
We truly APPRECIATE your COOPERATION! Hopefully , this summary will be helpful to you
throughout the course of your treatment. We value your input; therefore, please let us know if you
have any comments or suggestions. If you ever have a problem or question you feel is not being
addressed adequately, please contact me directly ! Have a pleasant stay in Houston and a safe trip
home.
Robert A. Weaver M. D,, C. P. I.
Certified Physician Investigator
Page 10 of 13
REFERENCES
1
Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Recurrent Diffuse Intrinsic Brain Stem
Gliomas - Drugs R & D 2003; 4(2): page 10-11.
2
Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Recurrent Diffuse Intrinsic Brain Stem
Gliomas - Drugs R & D 2003; 4(2): page 12.
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ANTINEOPLASTON INFORMATION INDEX
PAGE
ADEEBA AKHTAR M.D. ………………………………………………………………………………5
ANSWERING SERVICE (24 HOUR)……………………………………………………………..
9
ANTICONVULSANTS……………………………………………………………………………..
4
ANTINEOPLASTON A10………………………………………………………………………….
1
COMPOSITION……………………………………………………………………………….
1
MECHANISM OF ACTION………………………………………………………………….
1
ANTINEOPLASTON AS2-1……………………………………………………………………….
1
COMPOSITION……………………………………………………………………………….
1
MECHANISM OF ACTION…………………………………………………………………
1
ANTINEOPLASTON
"A BAG"……………………………………………………………………………………..
1
"BAG 1"……..………………………………………………………………………………
1
"BAG 2"……………………………………………………………………………………..
1
"B BAG"…………………………………………………………………………………….
1
INFUSION……………………………………………………………………………………
1
INVENTORY………………………………………………………………………………….
2
MAINTENANCE DOSE…………………….………………………………………………..
2
SHIPPING……………………………………………………………………………………..
2
STORAGE……………………………………………………………………………………..
2
APPOINTMENTS……………………………………………………………………………………
9
ASTENGENAL………………………………………………………………………………………
1
ASTUGENAL………………………………………………………………………………………..
1
BLOOD WORK…………………………………………………………………………………….
3
BURZYNSKI BREAKTHROUGH………………………………………………………………..
8
BURZYNSKI CLINIC
ADDRESS……………………………………………………………………………………..
8
ANSWERING SERVICE (24 HOUR)………………………………………………………
9
CLINIC HOURS………………………………………………………………………………
9
DOCTORS…………………………………………………………………………………….
7
FAX…………………………………………………………………………………………….
9
PHONE NUMBER……………………………………………………………………………
9
CENTRAL VENOUS CATHETER DRESSING…………………………………………………
3
CATHETERS
URINARY…………..…………………………………………………………………………..
5
CENTRAL VENOUS………………………………………………………………………….
3
CLINIC HOURS…………………………………………………………………………………….
9
CLINICAL RESEARCH COORDINATORS (CRCs)……………………………………………
7
CONSENT FOR TREATMENT…………………………………………………………………..
10
CONTRACEPTION………………………………………………………………………………..
4
COMPLIANCE…………………………………………………………………………………….
10
CVS PHARMACY………………………………………………………………………………....
6
DIETARY CONSULTATION……………………………………………………………………..
8
DISCHARGE DAY…………………………………………………………………………………
10
DISCONNECTING/RECONNECTING TO THE CENTRAL VENOUS CATHETER………
3
DOCTOR (LOCAL)…………………………………………………………………………………
7
FAX NUMBER………………………………………………………………………………………
9
FINANCIAL ISSUES……………………………………………………………………………….
8
FLUID INPUT AND OUTPUT……………………………………………………………………..
5
FLUSHING THE CATHETER…………………………………………………………………….
3
FOOD AND DRUG ADMINISTRATION (FDA) APPROVAL………………………………….
3
FOLATE (FOLIC ACID)……………………………………………………………………………
4
HOSPITALIZATION……………………………………………………………………………….
5
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ANTINEOPLASTON INFORMATION INDEX (CONTINUED)
HOUSTON MEDICAL IMAGING………………………………………………………………..
6
MAGNETIC RESONANCE IMAGING (MRI)…………………………………………………..
6
MEDICAL ASSISTANT...………………………………………………………………………….
8
MEDICATIONS…………………………………………………………………………………….
4
MEMORIAL HERMANN MEMORIAL CITY HOSPITAL…………………………………………5
NURSES……………………………………………………………………………………………..
7, 8
OPERATING A MOTOR VEHICLE……………………………………………………………..
8
ORPHAN DRUG DESIGNATION (ODD)………………………………………………………..
10
PARKING……………………………………………………………………………………………
..9
PATIENT SUPPORT GROUP…………………………………………………………………….
8
PHARMACIES (LOCAL)………………………………………………………………………….
6
PSYCHOLOGICAL REFERRALS……………………………………………………………….
6
PUMP…………………………………………………………………………………………………
1
RADIOLOGY CONSULTATION…………………………………………………………………
7
REFERENCES………………………………………………………………………………………
11
SECURITY…………………………………………………………………………………………..
9
SOUTHERN FAMILY PHARMACY……………………………………………………………..
6
SPECIAL OR COMPASSIONATE EXCEPTION (CE)………………………………………….
2
STEROIDS…………………………………………………………………………………………..
4
SUGGESTIONS……………………………………………………………………………………..
10
SUPPLEMENTS…………………………………………………………………………………….
4
TEXAS CHILDREN’S HOSPITAL………………………………………………………………..
5
TIME DURATION IN HOUSTON………………………………………………………………..
5
VITAMIN B12……………………………………………………………………………………….
4
WALGREEN'S PHARMACY………………………………………………………………………
6
WALGREEN'S 24 HOUR PHARMACY………………………………………………………….
6
Revised 3/30/05
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