NEWS HIGHLIGHTSMedia Articles Related to Zenapax (Daclizumab)
Independent Study Utilizing Cyclic Levulan PDT Finds 95 Percent Reduction In New Squamous Cell Carcinoma Lesions In Solid Organ Transplant Recipients
Source: Dermatology News From Medical News Today [2009.11.11]
The results of an independent investigator study just published in the online version of Dermatologic Surgery demonstrate that Levulan(®) Photodynamic Therapy (PDT) may reduce the rate of recurrence of squamous cell carcinomas (SCCs) in solid organ transplant recipients (SOTRs), a population with a high incidence of nonmelanoma skin cancer.
Published Studies Related to Zenapax (Daclizumab)
Impact of daclizumab, low-dose cyclosporine, mycophenolate mofetil and steroids on renal function after kidney transplantation. [2009.09.22]
BACKGROUND: Early and long-term use of cyclosporine A (CsA) leads to increased risks of renal toxicity. We hypothesized that administration of daclizumab in combination with mycophenolate mofetil (MMF) allows a relevant reduction in the dose of CsA... CONCLUSION: We demonstrate here that high-dose daclizumab in combination with lower CsA levels in adult renal transplant recipients is as or more effective than standard regimen (CsA, MMF, steroids) and may result in better outcomes at 12 months post-transplant with no increase in adverse reactions.
Daclizumab versus antithymocyte globulin in high-immunological-risk renal transplant recipients. [2009.06]
Nondepleting anti-CD25 monoclonal antibodies (daclizumab) and depleting polyclonal antithymocyte globulin (Thymoglobulin) both prevent acute rejection, but these therapies have not been directly compared in a high-risk, HLA-sensitized renal transplant population...
Patient outcomes in two steroid-free regimens using tacrolimus monotherapy after daclizumab induction and tacrolimus with mycophenolate mofetil in liver transplantation. [2008.12.27]
INTRODUCTION: Long-term steroid administration may predispose liver transplant recipients to infectious and metabolic complications. Maintaining effective immunoprophylaxis while minimizing the negative consequences of steroid therapy could be a key factor in improving clinical outcomes... CONCLUSION: Both TAC-based regimens allowed optimization of immunoprophylaxis while eliminating some of the negative consequences associated with steroids. Efficacy outcomes were comparable; however, TAC monotherapy after DAC induction was associated with significantly less leucopenia and less bacterial infection than a dual regimen incorporating MMF.
Daclizumab improves asthma control in patients with moderate to severe persistent asthma: a randomized, controlled trial. [2008.11.15]
Rationale: Airway inflammation in asthma is associated with increased activated CD25(+) T cells, IL-2, and soluble IL-2 receptors (IL-2Rs). Objectives: A randomized, double-blinded, placebo-controlled study was used to evaluate the safety and efficacy of daclizumab, a humanized IgG1 monoclonal antibody against the IL-2R alpha chain (CD25) of activated lymphocytes, in adults with moderate to severe persistent asthma...
A randomized, controlled trial of daclizumab vs anti-thymocyte globulin induction for lung transplantation. [2007.05]
BACKGROUND: Rejection remains a significant cause of morbidity and mortality after lung transplantation. The purpose of this study was to test the efficacy and safety of daclizumab (DZM) vs anti-thymocyte globulin (ATG) as a component of induction therapy... CONCLUSIONS: DZM is a safe component of induction therapy in lung transplantation. In addition, DZM may prolong freedom from acute rejection. Significant infections were more frequent in the DZM group, but this was likely due to a higher incidence of CMV mismatch. Both methods of induction therapy worked well, with excellent 1-year survival.
Clinical Trials Related to Zenapax (Daclizumab)
Human Anti-Tac (Daclizumab) to Treat JIA-Associated Uveitis [Completed]
This study will examine the safety and effectiveness of a monoclonal antibody called
humanized anti-Tac (HAT, also called daclizumab) to treat children and adolescents with
uveitis (chronic inflammatory eye disease) associated with juvenile idiopathic arthritis
(JIA). Monoclonal antibodies are genetically engineered proteins made in large quantities and
directed against a specific target in the body. The HAT antibody is designed to prevent a
specific chemical interaction needed for immune cells to produce inflammation. Current
treatments for uveitis include steroids and immune-suppressing drugs. These treatments do not
always work or they may cause significant side effects. This study will determine whether
daclizumab can improve uveitis in children and reduce the need for other medicines.
Patients between 6 and 18 years of age with active non-infectious JIA-associated uveitis
requiring treatment with anti-inflammatory medications as often as three times a day or more
may be eligible for this study.
Each candidate is screened with a medical history, physical examination, blood tests, eye
examination, and the following specialized tests:
- Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected
into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina
are taken using a camera that flashes a blue light into the eye. The pictures show if
any dye has leaked from the vessels into the retina, indicating the presence of
inflammation.
- Optical coherence tomography to measure retinal thickness. The eyes are examined through
a machine that produces cross-sectional pictures of the retina. These measures are
repeated during the study to determine changes, if any, in retinal thickening.
- Stereoscopic color fundus photography to examine the back of the eye. The pupils are
dilated with eye drops to examine and photograph the back of the eye.
Upon entering the study, participants receive a 90-minute infusion of daclizumab through a
catheter (plastic tube) placed in an arm vein. They return to the clinic after 14 days and
again after 28 days for repeat eye examinations, blood tests, and daclizumab infusions. Four
weeks after the third infusion, patients are examined for response to treatment. Those who
have benefited from daclizumab may continue receiving monthly infusions of the drug for up to
one year. A blood test and eye examination are done at the time of each infusion. Patients
whose disease has remained active 12 weeks after the first infusion are taken off the study
and treated with other medications.
Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple Sclerosis [Active, not recruiting]
This study will examine the safety of Zenapax (daclizumab) in patients with multiple
sclerosis (MS). MS is thought to be caused by an over-reactive immune response. T-lymphocytes
(cells of the immune system), are thought to damage myelin, a substance that covers the nerve
and parts of the spinal cord and is damaged in patients with MS. Interleukin-2 is a natural
substance in the body that is necessary for the growth of T-lymphocytes. Zenapax is a
genetically engineered antibody that blocks the activity of interleukin-2 and thus interferes
with the growth of lymphocytes. Therefore, Zenapax may prevent some of the damage to myelin
that occurs in multiple sclerosis.
Patients between 18 and 65 years of age with relapsing remitting MS may be eligible for this
study. Patients with secondary-progressive or primary progressive MS may not participate.
Candidates will be screened with a complete neurological and medical evaluation and review of
medical records.
Participants will undergo the following tests and procedures:
- Baseline evaluation: Participants have four magnetic resonance imaging (MRI) scans over
a 3-month period to assess disease activity. For the MRI scans, the patient lies on a
table that slides into the scanner - a narrow metal cylinder with a strong magnetic
field. Scanning time varies from 20 minutes to 3 hours, with most scans lasting between
45 and 90 minutes. Only patients with activity at or above a certain level are eligible
to continue with the treatment phase of the study.
- Zenapax treatment: Patients receive intravenous (through a vein) infusions of Zenapax.
The first two infusions are 2 weeks apart, followed by 13 monthly infusions.
- MRI scans: Patients undergo MRI scanning before every infusion to evaluate disease
activity and identify new brain lesions.
- Blood and urine tests: Blood and urine samples are collected at each clinic visit for
routine laboratory evaluations, immunologic study, and genetic testing to determine a
predisposition for responding to Zenapax treatment.
- Lumbar puncture (spinal tap): This procedure will be done during the last month before
starting treatment and during the seventh month of treatment to examine immune changes
that occur in the cerebrospinal fluid (CSF), which circulates through and surrounds the
brain and spinal cord. A local anesthetic is given and a needle is inserted in the space
between the bones in the lower back where the CSF circulates below the spinal cord. A
small amount of fluid is collected through the needle.
- Skin test: A needle is placed just under the skin is done to assess the patient's immune
status to common antigens such as tetanus, mumps and candida.
- Lymphocytopheresis: Lymphocytes are collected three times - once during the last month
of baseline before starting treatment, once during the fifth month of treatment, and
once during the last month of treatment - for immunologic study. Blood is collected
through a needle in an arm vein in a similar way to donating blood. The blood flows from
the vein through a catheter (plastic tube) into a machine that separates it into its
components by centrifugation (spinning). The lymphocytes are removed and the rest of the
blood (red cells, plasma and platelets) is returned to the body, either through the same
needle or through another needle in the other arm.
ANTI-TAC THERAPY FOR UVEITIS [Completed]
Uveitis refers to intraocular inflammatory diseases that are an important cause of visual
loss. Standard systemic immunosuppressive medications for uveitis can cause significant
adverse effects. Consequently, an effective treatment with a safer side effect profile is
highly desirable.
This pilot study has permitted enrollment of up to 12 adults with non-infectious intermediate
or posterior uveitis who require treatments to maintain visual function. This extended
protocol began with an evaluation of the safety and potential efficacy of intravenous (IV)
daclizumab treatments for uveitis while reducing or eliminating standard medications
commensurate with the standard of care. As subcutaneous (SC) daclizumab treatments become
available, eligible participants will be offered continuing daclizumab treatments using the
new SC formulation, though they may elect to remain on the IV treatments. If the therapeutic
benefit is sustained using the SC formulation, maintenance therapy will continue as
clinically indicated. Participants who repeatedly fail the SC therapy will be permitted to
revert to the IV daclizumab regimen they previously used, or may exit the study as treatment
failures. SC treatments begin with a short SC induction at 2 mg/kg followed by 1 mg/kg
treatments on a 4-week schedule as the protocol originally specified. Participants will be
monitored routinely when each dose is received and additionally will participate in
pharmacokinetic studies to monitor SC formulation bioavailability.
Daclizumab is a humanized anti-Tac monoclonal antibody (HAT, Zenapax) that interferes with
inflammatory processes by its involvement with the interleukin 2 receptor (IL-2R). During
the first 5 years of this study, only an IV product was available. The SC formulation is now
available containing the same daclizumab drug product. Preliminary studies indicate that the
SC formulation is well tolerated by normal control subjects and other autoimmune disease
patients at repeated doses up to 2 mg/kg.
The primary objectives are to examine the safety and potential efficacy of IV and later, SC
daclizumab, while continuing to reduce other immunosuppressive medications commensurate with
the standard of care. Primary safety outcomes are the discontinuation of study therapy due
to reduced vision or the occurrence of adverse events. Secondary outcome measures include
visual acuity and the grading of immunosuppressive medications, anterior chamber and vitreous
cells, and vitreous haze.
Daclizumab Versus Thymoglobulin in Renal Transplant Recipients With High Immunological Risk [Completed]
To compare renal allograft rejection rates during the first year among high-immunological
risk recipients between patients who received either ATG or the anti-IL2R mAb daclizumab.
Zenapax to Treat Multiple Sclerosis [Active, not recruiting]
This study will examine the safety and effectiveness of Zenapax (a laboratory-manufactured
antibody) in treating multiple sclerosis. Multiple sclerosis may be caused by an abnormal
immune response in which white blood cells called T lymphocytes attack the myelin sheath that
covers nerves and parts of the spinal cord. Zenapax binds to protein receptors on
lymphocytes, keeping them from interacting with interleukin-2, a substance necessary for
their growth.
Patients with multiple sclerosis who have had at least one relapse within 18 months of the
start of the study and in whom interferon-beta treatment has not been successful may be
considered for this study. There are two study phases: baseline and treatment. During the
baseline phase, patients will have three magnetic resonance imaging (MRI) scans over 2 months
to evaluate their disease activity. During treatment, patients will receive seven
intravenous (I. V.) infusions of Zenapax in the clinic. The first two infusions will be given
2 weeks apart; the next five will be given once a month.
Patients will have MRI scans before each infusion. The MRIs will be done using the standard
procedure and again using a contrast agent, gadolinium, injected into a vein. Gadolinium
helps identify new multiple sclerosis lesions in the brain. Blood and urine samples will be
taken during each clinic visit. In addition, patients will have skin tests, similar to a
tuberculin test, to evaluate immune status, and will be asked to undergo two lumbar punctures
(spinal tap; these will be optional)-one before the treatment phase begins, and another when
treatment is completed. Lymphocytes will also be collected from patients before, during and
after treatment. The lymphocytes are obtained by a procedure called apheresis: about a pint
of whole blood is drawn through a needle in the arm, the lymphocytes are separated out and
removed by a machine, and the rest of the blood is returned through a needle in the other
arm. These studies will hopefully allow conclusions about the safety of Zenapax in MS, but
also address its effectiveness with respect to modifying the inflammatory activity in the
brain of MS patients and inhibit autoimmune T lymphocytes that are involved in the disease
process.
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