Thursday, May 10, 2007

Cytos Responds!

I wrote to Cytos some time ago to ask about progress on their anti-TNF-alpha vaccine (TNFQb). The Cytos Director of Corporate Communications wrote back the next day with an update. I have posted her email below.

She says in the email that we can expect results from their latest clinical trials to be published between now and the end of June. I hope all goes well. Imagine having your own body produce the anti-TNF-alpha antibody. It would be so much safer, easier and cheaper.

Right now the cost of our son's Enbrel is $3000US a month. Lucky for us, my wife has family medical insurance through her work. Without her insurance we would not be able to afford the medicine. Her insurance covers only part of the costs of his medicine and physcian appointments. We still pay several thousand dollars a year for those costs. But without her insurance, our costs would approach forty thousand dollars a year. We would be bankrupt in a year or two.

Here in the US, if you cannot work at a place with family medical coverage, you cannot afford most medications. We do not have universal health care like the rest of the industrialized world. Very sad.

It takes a lot of money to buy TV ads in US. The candidate with the most TV ads almost always wins. Only major corporations have enough money to donate to politicians to pay for those ads.

Big Pharma is the biggest corporate donor, followed by Big Oil and major insurance companies.

Politicians who want to be re-elected must pass the legislation that Big Pharma and other big corporations want. Therefore no control on drug price. No universal health care that would put insurance companies out of business. Regulatory agencies that were created to protect ordinary citizens are now all run by mangers and lobbyists on loan from major corporations.

The Cytos email follows:

Dear Mr. Welch,

many thanks for your e-mail and your interest in our vaccine TNFQb. I have summarized below the current status for this vaccine candidate for your information. I hope this is helpful. I will also put your address on file, if this is fine with you, so you will be getting the news on this product candidate in future.

In October 2004, Cytos initiated a combined phase I/IIa clinical trial with TNFQb. The randomized, double-blind and placebo controlled study includes 48 patients with moderate to severe plaque psoriasis and is designed to evaluate the safety, tolerability and exploratory efficacy of the vaccine. Three different dose regimens have been already tested in a first part of this study. Initial clinical observations obtained in December 2005 suggested that the vaccine candidate is safe and generally well tolerated. Furthermore, it was observed that the number of patients who mounted an anti-TNF-α-specific antibody response was identical to the number of patients scheduled to receive TNFQb (study still blinded). The antibody levels were found to decline over time in all these individuals. This is an important safety feature for an Immunodrug™ targeting a self-molecule.

In 2006, the second part of this phase I/IIa study was performed with 24 patients. The highest previously tested and well tolerated vaccine dose (i.e. 300 μg) was compared with placebo. The patients in this second part of the study have completed the treatment period and data management is currently in progress. Throughout the treatment period, no safety concerns were raised and all vaccine injections were performed as planned. The first phase I/IIa study results are expected in this second quarter 2007.

I am sorry that I can not give you more detailed results right now and I wish you and your family all the best.
With best regards,
(name withheld)
Director Corporate Communications
Cytos Biotechnology

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