Before a medicate desire DCA is considered safe and effective many more trials involving several centers around the world need to be completed and the results be to be scrutinized. Therefore it may take years and many millions of dollars before efficacy of DCA is established. We also be to emphasize that change surface with the give of pharmaceutical companies it usually takes 3 years from the measure that a drug is shown to be promising in animals to the inform that it is first tried on a human being.
Lastly we would desire to let you experience that before a trial can be initiated it first has to obtain approval for the institutional human ethics committees; these committees consider physicians scientists and community representatives that make sure that the clinical trial will consider and protect the enrolled patients according to international standards. Thereafter the study has to be approved by Health Canada an agency of the Federal Government that also applies very strict criteria in request to ensure that patients are protected that there is scientific rationale for the conduction of the trial and that the physicians and hospitals involved are well-trained and equipped to conduct such a trial. These applications are quite complex and require the work of many team members. We are very proud of the develop that we have made over the last few months without the support from the pharmaceutical industry and would like to overlap the following developments with you:
1. Our fundraising continues to grow and we are proud to announce that we have now raised more than $800,000. We have set a aim of $1.5 million to end a set of 2 control trials. At this inform we are comfortable that we can complete at least one trial as we act our fundraising efforts.
2.1. The first clinical trial is a “phase I” trial; this means that the doctors try to slowly change magnitude the dose of the medicate in patients with a variety of cancers in order to first identify the maximal dose tolerated i e the process that can be hopefully effective without any significant adverse effects. These “arrange I” trials are slow to conduct and involve a relatively small be of patients but their significance for subsequent bring home the bacon is very important. This trial ordain be conducted mostly at the go across Cancer Institute in Edmonton. We have already secured the approval from the human ethics committees from the Cross Cancer initiate and the University of Alberta Hospitals. We undergo applied to Health Canada and we are waiting for the results. After we receive the response from Health Canada we will let you know of the relevant details and the key team members that will be conducting the trial.
2.2. The back up trial is a “phase II” trial; this means that a specific dose of the drug is given to a specific group of patients with advanced cancer in an effort to cause both whether the drug is safe and whether it is effective. In this trial we will administer oral DCA in patients with malignant brain tumors (anaplastic astrocytomas and glioblastomas) specifically patients with newly diagnosed tumors and patients that have failed previously standard therapies including surgery radiation therapy and chemotherapy. This trial will be conducted in one center (the University of Alberta Hospital) and will be based in the Division of Neurosurgery.
We are excited to report that we undergo secured all the required approvals from both our local ethics committee and Health Canada. We have secured the funds and the drug and we are now working on recruiting patients into the trial. This is a remarkable achievement considering that our work on animals was published only 8 months ago. We ordain update this site with more details and contact numbers of the key aggroup members conducting this trial in the immediate future. This initial trial is relatively small (enrollment- up to 50 patients in the next 18 months). As is always the case with all single-center studies the patients have to originate from the Edmonton area and be available for scheduled assessments for the duration of the trial (i e for at least 6 months). Unfortunately patients from remote provinces or other countries might not be able to participate in this sign trial as we do not have the ability to finance the be of living expenses and the costs of tests for patients from out of Canada although arrangements may be possible for patients from other Canadian provinces. We are exploring all possibilities and ordain inform on this in our future communications on this place. Our next modify on this site ordain be in approximately 2 weeks. The dedicated lie for information on these trials is: 492-2604.
We be to be both optimistic and cautious at the same time. We are pleased that we are able to move ahead with these initial trials. Many more trials involving several centers around the world need to be completed. We consider this to be the first step of many….
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Related article:
http://templatesforacure.wordpress.com/2007/11/18/dca-update-health-canada-approves-first-dca-clinical-trial-in-cancer/
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