dendritic cell info
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DENVAXTM- DENDRITIC CELL THERAPYCustomized Cell-based Cancer Immunotherapy
DENVAXTM
Dendritic Cell Therapy
ICT
Nurturing Cel ls for Lives
INSTITUTE OF CELLULAR THERAPIES PVT LTD
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Dendritic Cells (DCs) are the key ANTIGEN
PRESENTING CELLS (APCs) of the immune
system. They are the cells that INITIATE,
DIRECT and REGULATE the immune responses.
What are Dendritic cells and how are they
useful in fighting against cancer cells?
Dendritic cells considered the pacemakers of the
immune system, were originally identified by Steinman
and his colleagues in the early seventies. They are
crucial to the presentation of peptides and proteins to B
and T lymphocytes and are the key antigens presenting
cells. They are critical for the induction of T cell
responses resulting in cell-mediated immunity.
It is the T cell receptors on the T lymphocytes which
recognize fragments of antigens bound to molecules of
the major histocompatibility complex (MHC) on the
surfaces of APCs (dendritic cells). The peptide binding
proteins, which are of types I and II, interact with and
stimulate cytotoxic T lymphocytes (CTLs) and T helper
cells.
The antigens from a cancer cell or virus infected cell,
on entry into the APC, are processed, spliced into
peptides and then re-expressed on the cell surface
linked to MHC proteins. This results in generation of
CTLs which recognize and destroy cells which express
the antigen. The T helper cells which when activated in
turn have profound immunoregulatory effects.
Therefore, DCs play a key role in host defenses and a
crucial role in anti-cancer immune responses
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What is Denvax?
The Denvax is dendritic cell-based cancer
immunotherapy for solid cancers in various stages
of disease. It is autologous treatment, which
involves patients own mononuclear cells
transformed into cancer-specific dendritic cells.
Designed to be specific, Denvax targets only the
cancer cells without harming the healthy ones. It is
safe and effective and works best to prevent
relapse and recurrences, the major cause of
mortality and morbidity in cancer.
Denvax helps in correcting the failed immune
surveillance and teaches the immune system to
recognize and kill the cancer cells.
Why do cancers relapse?
A cancer relapse occurs because in spite of the
best efforts to get rid of cancer, some cancer cells
are left behind. These cancer cells remain dormant
for a period of time, but eventually they continue to
multiply resulting in the recurrence or relapse.
What is the best way to treat relapse?
Cancer treatment modalities like surgical
resection, chemotherapy and/or radiation are
mostly ineffective in controlling the
micrometastasis. Micrometastases are single
tumor cells or clusters of cells shed by solid
cancers and disseminated in various organs of
the body. Micrometastases have a pronounced
clinical effect, are hard to detect and can be the
starting point of recurrence of cancer.
Denvax targets the micrometastasis and
destroys the disseminated cancer cells, thereby
preventing its development, slowing the spread
of cancer and improving the life expectancy.
Under what treatment modality does
Denvax fall?
Denvax is autologous cancer cell
immunotherapy. It is also called dendritic cell
therapy, cancer vaccine therapy, active-specific
immunotherapy, customized therapy, and
biological therapy.
FACTSABOUTDENVAX
Denvaxdelaysdiseaseprogressionandimprovessurvival
Denvaxcanbegivenaloneorincombinationwithothermodalitiesofcancertreatment
Dendriticcelltherapycomesunderthefourthmodalityofcancertreatment,calledImmunotherapy;theotherthreearesurgery,
radiationandchemotherapy Denvaxgivenconcurrentlywithchemotherapyhelpsinalleviatingtheadverseeffectsofthechemotherapy
Denvaxarepatientsownmononuclearcellsmanipulatedintocancer-fightingdendriticcells;thusthereisnograftversushost
reaction,norchancesofacuteordelayedtypehypersensitivity
Denvaxiseasytomanufactureandadminister,duetoCellNuteTM,atransportmediumdevelopedbyICT
CellNuteTMhelpstopreserveandkeepthecellsviablefor19hours,underdesiredconditions
PatientsneednotvisitICTLab,theirbloodcanbecollectedinCellNuteTMandtransportedtoICTinthespecifiedtimeframe
BestresponderstoDenvaxarepatientswhohavecompletedconventionaltherapybutareinthevulnerablehighrelapsegroup
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STEP 1To manufacture a single dose of
DENVAXTM
, a fresh sample ofperipheral blood (20-40 ml inamount as per the TLC count) ofthe patient is collected in
CellNute
TM
medium provided byICT Lab Services.
The day blood is drawn isconsidered Day 1 of the protocol.
STEP 4
The mature dendritic cells are
harvested on Day 8 to be re-infused into the same patient.
The dendritic cell preparation,called Denvax, is administeredintravenously into the patient asan infusion, in 100 ml Dextrose
Normal Saline (DNS) in twentyminutes.
STEP 2
Peripheral blood mononuclear
(CD14+) cells are isolated andcultured in cytokines along withthe desired nutritional media.
STEP 3
These cells transform into the
immature dendritic cells. Formaturation, these cells areexposed to cancerous antigen onDay 6 of blood drawl.
Exposure of DCs to cancerousantigen leads to maturation ofdendritic cells and these matureDCs release various interleukins(specifically IL 12).
Cancerous antigens are bits of protein required for maturation of dendriticcells. This cancerous antigen may be extracted from either source:
a) The patient's Wax Embedded Tissue: tumor tissue preserved in wax forbiopsy examination for further studies;
b) Formalin Fixed Tissue: patients tumor tissue preserved in formalin at thetime of surgery for further studies;
c) Fresh FNA Tissue: fresh sample of tumor tissue derived from Fine NeedleAspiration.
The cancerous antigens derived from patient's own tumor tissue are called
Tumor Associated Antigens, or TAAs.
In cases where self-tumor antigens are not available, non-self tumor antigensare used for dendritic cell maturation. The non-self antigens are derivedfrom different sources, similar in nature, and called Tumor Specific Antigens,or TSAs.
DENVAX is also prepared by collecting a greater number of CD14+ cells by apheresis
procedure. This allows for a 'one-time' cell collection for multiple dosages. APHERESIS is
a cell collection device that helps to collect a large number of desired cell population
(CD14+ cells in this case) without having to undergo multiple blood drawl procedures. This
saves on travel costs as well as time. Once a DENVAX is prepared by Apheresis method,
it can be stored under optimal conditions at ICT and timely dosages can be administered to
the patient, as per the treatment protocol. DENVAX prepared by this method is many-fold
potent as Apheresis allows for collection of greater number of purified cell population. The
COBE Spectra Apheresis System is a cell collection device by CaridianBCT. It is a
device which is cleared both by FDA as well as European Medical Device Directive, for
mononuclear cell and peripheral blood stem cell collection.
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FAQs
What are Dendritic cells and how are they useful?
Dendritic cells are blood cells present in every person's bloodstream. They
function as an immune cell but are present in small numbers. They identify cancercells, process them into bits, and jumpstart the immune response by bringing the
foreign substance to the attention of the rest of the immune system (T cells). Theactivated immune system is then able to circulate throughout the body anddestroy the cancer cells.
What happens to the immune system incancer?
In cancer, the immune system fails; cells of the
immune system fail to recognize the cancer cells. Theimmune system doesn't "see" tumors as dangerous
or foreign, and doesn't mount a strong attack against
them. Another reason tumors may not stimulate animmune response is that the cancer cells develop
ways to escape the immune system.
What is Denvax (Dendritic cell therapy)?
Cancer occurs because the immune system has failed. Numerousresearches now prove that this defect in the immune system can
be corrected outside the body (ex vivo technology). Denvax isdendritic cell therapy, which involves the extraction ofmononuclear (CD14+) cells from the patient's own blood,
transformation of these cells into cancer-fighting dendritic cellsand giving back to the patient.
How is Denvax prepared?
Mononuclear (CD14+) cells are extracted from
the patient's peripheral blood. These cells arecultured, exposed to maturation stimuli and
then re-infused into the same patient on the8th day of blood collection.
What kind of cancers can be treatedby Denvax?
This includes solid tumors mainly, including
cancers of the breast, bone, brain, bladder,gastrointestinal tract, head & neck,
pancreatic, gallbladder, liver, renal, lung,lymphoma, multiple myeloma, ovarian,pancreatic, prostate, and testicular.
At what cancer stage should a patient considerDendritic Cell therapy?
A patient may consider DC therapy when:
the patient is free of disease but at a risk of recurrence palliation is required patient requires immune-therapy in addition to ongoing
chemo/radiation therapy
How are Dendritic cells made to recognize thepatient's tumor cells?
Dendritic cells should recognize the patient's tumor cells and
target them once inside the body. But before that they mustundergo 'maturation'. For this the dendritic cells are exposed
to tumor antigen-self or non-self.
Who will benefit most from the therapy?
Dendritic cell therapy works best in patients:
who opt early during the disease progression; who opt immediately after surgery, when tumor
load is minimal.
What are the side effects ofDenvax?
There are minimal side effects.Some patients may experience
mild-moderate grade fever aftervaccine administration lasting 24-48 hours. Some may experiencelethargy/weakness for few days.
What are the contraindications toDenvax?
There are no contraindications to this therapy.
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.
www.dendriticcellresearch.com
Institute of Cellular Therapies
The Institute of Cellular Therapies (ICT) is the firstand only to offer customized dendritic cell therapyDenvax in India.
ICT Mission
To provide the highest quality of cell therapy atlowest prices, to make the treatment affordable
to a large number of patients.
To individualize each treatment plan andprovide comprehensive treatment in cancer tohelp them overcome their disease.
To help patients achieve complete remissionand prevent relapses by initiating treatment atthe right time, when tumor load is minimal.
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Tel :91-120-2500111/95
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Email :info@dendrit iccellresearch.com
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Email: naveen@carerm.com,
naveenkarun@gmail.com
ICT
Nurturing Cel ls for Lives
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