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Pipeline
Philosophy
RENCAREX®
REDECTANE®
uPA Program
Publications
For Patients
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For
Patients
Thank you for visiting the “For Patients” part
of our website.
Please read this first
WILEX is developing novel cancer therapies.
No drug developed by WILEX has received regulatory approval in any country
of the world so far. That means the drugs cannot be prescribed nor purchased
for therapy at present.
Some of the drug candidates developed by WILEX are currently being given
to patients in clinical studies.
To learn more about clinical studies in general, please click here.
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The clinical studies currently ongoing with WILEX’s
drug candidates are being conducted with patients in the following cancer
indications:
- Non-metastatic renal cell carcinoma (kidney cancer) (international
study)
The Phase III study evaluates WILEX’s drug candidate WX-G250 (RENCAREX®*)
as a treatment for patients with renal cell carcinoma (RCC), a form of
kidney cancer. Patients who can participate in this study must have been
diagnosed with non-metastatic clear cell RCC and, in addition, must have
a high risk of a metastatic relapse after the affected kidney has been
removed through surgery. Moreover patients have to meet further criteria
in order to be able to participate in the study. For more information
on the study and on participating countries and hospitals you may click
here.
Recruitment was completed in July 2008.
- Pancreatic cancer
This Phase II-trial is a randomised, open label trial in patients
with locally advanced, inoperable, non-metastatic pancreatic
cancer. Patients are to be treated with oral MESUPRON®*
once-a-day in combination with the standard treatment of Gemcitabine
(intravenous once weekly).
Recruitment was completed in July 2008.
- Kidney cancer
In this Phase III registration trial with REDECTANE®* patients suspected
of having kidney cancer will be enrolled in more than 15 centres in the USA.
Patients included are scheduled
for complete or partial surgical removal of the affected kidney.
They will be imaged with computer tomography (CT) and REDECTANE® (positron
emission tomography (PET) / CT) prior to surgery to examine whether they
have clear cell renal cell carcinoma. The trial will evaluate whether imaging
with
REDECTANE® can improve the diagnosis in comparison to the current standard
(CT alone).
For more information on the study please visit www.clinicaltrials.gov.
The study identifier is NCT00606632.
- Breast cancer
This Phase II trial in patients with HER2-receptor negative metastatic
breast cancer will evaluate the efficacy of combination therapy
of WX-671 and Capecitabine in comparison to Capecitabine monotherapy. Patients
will
receive daily doses of WX-671 in one treatment arm while the
other treatment arm will receive placebo. All patients will receive daily
Capecitabine concomitantly
for the first 2 weeks of every 3 week cycle.
For more information on the study please visit www.clinicaltrials.gov.
The study identifier is
NCT00615940.
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| Request for further information on clinical studies with WILEX’s
drug candidates
If you wish to receive more information about the clinical studies currently
ongoing with drug candidates developed by WILEX or should you consider
participating in one of these studies, you may contact us here.
All statements are voluntary. All submitted data will only be used and
stored for the handling of your request and our response to it. It will
not be shared with any third party or used for any other purpose. Deletion
of all data can be requested at any time without cost or reason. The
processing of your request on clinical studies represents a processing
of health-related data according to German law requirements.
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| Please read this first
The “For Patients” part of the WILEX
website ("this
website") may contain information on clinical trials sponsored by
WILEX, and is provided for patients and healthcare professionals to increase
the transparency of WILEX’s clinical research.
Information contained within this website is not intended to replace
the advice of a healthcare professional and should not be considered
as a recommendation. Patients should always seek medical advice before
making any decisions on their treatment.
Data on this website may differ from published or presented data and
are a reflection of the limited information provided here. The results
from a single trial need to be considered in the context of the full
clinical research of a drug.
All reasonable precautions have been taken to ensure
the accuracy, security and confidentiality of information available through
the site. WILEX may amend the information at any time without notice.
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| About clinical studies
A clinical trial, often referred to as a clinical study or research
study, is designed to determine whether a new drug or treatment will
alleviate a disease or be of potential benefit to patients. Clinical
trials allow physicians and researchers to gather information on the
benefits, side-effects, and possible applications of new drugs, as well
as different drug combinations, doses, and new indications areas for
existing drugs. As a result, the medical community may be able to devise
new ways to detect, diagnose, avoid, and control clinical factors responsible
for diseases.
Without these studies there would be little hope for new and more effective
medicines to combat cancer and other harmful or life-threatening diseases.
In order to ensure a maximum protection of the patients and volunteers
participating in a clinical study, the process of clinical development
is carefully and strictly regulated by a comprehensive set of laws, as
well as monitored by the regulatory authorities of the respective countries
and the ethics commissions of the institutions where the trials are being
conducted.
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| Clinical development in cancer therapy typically comprises
three phases
Phase I: safety and tolerability
In Phase I clinical studies, a new drug candidate is administered to
healthy volunteers or patients in order to test the safety and tolerability
of the drug. The drug candidate must prove to be devoid of non-tolerable,
adverse and/or toxic side-effects.
Phase II: safety and efficacy
In Phase II trials, as well as safety and tolerability of the drug candidate,
first signs of clinical efficacy, e.g. anti-tumour efficacy or survival
benefits related to the drug candidate, are evaluated.
Phase III: comparison to standard treatment regimes
If in Phase I and II trials the drug candidate has proved to be reasonably
safe and shown signs of clinical efficacy, Phase III clinical trials
may be started. In Phase III trials, the drug candidate is compared
to standard treatments where available in large patient groups to determine
whether the drug candidate shows a statistically significant clear
therapeutic benefit over the standard treatment. If such a clear therapeutic
benefit can be demonstrated in the Phase III study, the company may
apply to receive marketing approval for the drug candidate from the
regulatory authorities.
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* temporary name while under development |
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| © 2006 WILEX AG |
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