Just got this from Sam Dawson at cancercarecvm@yahoo.com.Seems weird, I'm no scientist but do you suppose the FDA thinks this cancer treatment has something to do with human cloning (because they use the word cell?)
"A very promising cancer therapy in late stage testing needs your help. Please write to the FDA (e-mail and mail address provided below):
A small US biotechnology company, CEL-SCI Corporation ( www.cel-sci.com <http://www.cel-sci.com> ), has had a very promising cancer drug pending for a Phase III (final study) approval before the FDA for 22, yes you are reading correctly, 22 months. This same application was approved by the Canadian regulators in only 2 months. The Canadians and the FDA are supposed to use the same approval standards. What is the FDA doing? Please let the FDA know that this is not right. Cancer patients are dying while the FDA is delaying.
The Company has spent $90 million to develop this product called Multikine. The FDA has previously allowed studies with Multikine in head & neck cancer, prostate cancer, cervical dysplasia and HIV-infected patients, at a time when there was no safety data and no survival data. In these studies Multikine was shown to be very safe and in head & neck cancer it increased long-term survival by about 40%. Since the Company was allowed to study the product when there was no safety or survival data and the Canadian FDA has already approved the study, one has to wonder why the FDA is not moving ahead. One has to hope that the influence of certain big pharmaceutical firms is not that strong at FDA. The only beneficiaries from Multikine's delay are the big pharmaceutical companies who would lose cancer product sales.
Let CEL-SCI run its Phase III clinical trial with Multikine and let the chips fall where they may!!!! If the drug turns out to be just half as good as it was in Phase II trials, it will be a breakthrough saving many lives.
The goal of Multikine is to make the first cancer treatment more successful. This means that Multikine would cure more patients with the first treatment. The Phase II clinical trial with Multikine showed about a 40% improvement in survival from Multikine. Anyone who has ever had cancer, or has a family member or friend with cancer, knows that recurrence of the cancer is bad, very bad. Multikine is designed to stop that recurrence.
Multikine cured 12% of head & neck cancer patients in 3 weeks, with no toxicity. Anyone who has ever seen the effects of radiation and chemotherapy can tell you how very amazing that is. On average Multikine killed 50% of the tumor cells in just a few weeks. It appears to enhance the killing of cancer cells with radiation and chemotherapy.
CEL-SCI's results were published in leading peer-reviewed journals. The Canadians approved the Phase III study in 2 months. Why is the drug not allowed to move forward with excellent safety and promising efficacy data when it was allowed to move forward when there was no data? Is the drug, now that there is promising data, a threat to someone?
Please write to the FDA and let them know that you find this delay unacceptable. A safe cancer drug with promise should not be held up for politics. Too many people are dying of cancer every day. FDA finally has a new Commissioner, Dr. Andrew von Eschenbach. He probably does not even know about this travesty. Let him know and ask him to look into this. He can make a difference. Please contact him today.
Please write to the Commissioner as a concerned citizen and ask him to move CEL-SCI's application along so that Multikine gets a chance to prove itself in Phase III studies. Patients are dying and there is a drug that looks like it could help a good number of them.
andrew.voneschenbach@fda.hhs.gov
http://mail.yahoo.com/...?
To=andrew.voneschenbach@fda.hhs.gov>
or
Office of the Commissioner, FDA
Parklawn Building HF-1
Room 1471
5600 Fishers Lane
Rockville, MD 20857
Please forward this letter to as many of your friends as possible and post it on chat board or blogs.
Thank you!!!!!!
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