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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.

 

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.

 

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.

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.

 
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.


  * temporary name while under development