The description of how PDT developed at Roswll Park Cancer Institute starts with the 02/19/08 entry at the end.
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The description of how PDT developed at Roswll Park Cancer Institute starts with the 02/19/08 entry at the end.
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Our Photodynamic Therapy (PDT)Center recently received our 4th Program Project grant(PO1 grant) from the National Institutes Of Health,National Cancer Institute Division. These grants are special types of grants involving several departments here as well as outside institutions,and includes numerous researchers and support staff,all working together on a single topic,PDT in our case. We have biologists,chemists,laser specialists,immunologists (PDT actually induces an immune response which may be helping wipe out the cancers )and importantly clinical staff.
The grants run for 5 years and then we must again compete for a continuation in what is an increasingly competitive time -funds are always short and NIH funds only a small fraction of grants submitted to it-maybe 10-15%.The total funding we have received beginning with the first one now exceeds $40mil. These funds have allowed us to study the mechanisms involved in PDT, which we have found to be much more complicated than we ever imagined ( which actually makes it more fun!)and more importantly to expand our clinical trials both within the institute and to cancer centers in Pennsylvania and Minnesota. With the expansion of PDT to China and India noted previously we are reaching many more patients who can benefit from this unique treatment.
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An interesting aspect of developing new drugs,in our case photosensitizing drugs, is that after all the research,basic and clinical is completed it is necessary to license the patents for the drug to a pharmaceutical company since only they have the expertise and the MONEY to deal with the FDA and get the drug approved for general use. This requires first finding an interested company and then coming up with an Agreement of terms regarding what they will do ,what the restrictions may be and the payment of royalties to Roswell. With our new photosensitizer we ran into the problem that the patents were running out( they are good for 20 years from the time they are filed with the patent office). We have spent a lot of time attempting to license this compound and one company held the license for 5 years and did nothing with it! This is one of the things you try to cover in the Agreement so they cannot just hold on to it as patent time runs out.We missed on this one! A few years ago I was contacted first by a Chinese group and then by a company in India who were interested in licensing our new drug even though we had not patented the drug in either country.The negotiating experience with these groups was very different from that of the US companies we had dealt with previously. For one thing we could not expect to receive a signing fee, typical in the US, BUT the opportunity to reach such a huge population ,desperatly in need of new cancer treatments, over-road all other considerations.
I am happy to tell you that these negotiations have been successful and if all goes well photodynamic therapy will soon be availabl to hundreds of millions of people in China and India. This ,after all, is why we do what we do here!! All these dealings with drug companies,especially those from other cultures was a new and unexpected experience for me when I began my career in cancer research. It has been a very broadening,enjoyable and great education!
Feel free to ask any questions about this or anything else.
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If you want this story from the begining start at my first BLOG 02/08
There have been many advances in PDT since the early days; we have diode lasers to provide the light and specialized quartz fibers to deliver the light directly to the site of the tumor and have many more photosensitizers with improved properties over the first one. We have 2 lasers in the lab for experimental use and 2 in the hospital for patient treatment. We continue to expand PDT to new indications eg,cancers of the head and neck and intrapleural cancers.
It has been a long and difficult but wonderful experience.If you want to make a difference in people's lives this is great way to do it--and YOU CAN do it. I invite anyone to visit our PDT Center and see for yourselves what I have been describing will add some pictures and video later but don't wait for those,come ahead.
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I applied for a research grant on this to the NCI(National Cancer Institute) which was rejected out of hand with the comment:'it's an elegant idea but impractical to treat cancer since light does not penetrate tissue'. I reapplied and included a picture from the literature showing red light penetrating all the way through a human breast( they were trying to find tumors this way-it did not work out). Grant funded! After many more experiments I approached some of the clinical staff to see if we could try this in cancer patients.Most thought I was crazy,except for Dr Arnold Mittleman,a well known surgeon here;but we needed FDA approval to do this. The problem was that neither I nor anyone else here knew the first thing about how to do this!(This is no longer the case here which you can learn from Dr Candace Johnson's blog). So we learned how by talking to the people at the FDA who actually were quite helpful in guiding us through the process and we eventually received permission to treat patients.Dr Mittleman and I carried out the first ever clinical trial of PDT and found that PDT killed cancers in humans just like it did in mice.After several years carrying out numerous clinical studies as far as we could here, we needed to get help for the final step in the FDA approval process where,which if successful allows access to all cancer patients.This final phase is extraordinarily expensive and takes a long time. We needed to have help from the pharmaceutical industry who are experienced with these so called Phase III clinical trials and can afford to fund them. After several often frustrating attemps we finally succeeded in licensing the photosensitizer to a large pharmaceutical company who could complete the approval process and market PDT.The first FDA approval(1995) was for the treatment of obstructing tumors in the esophagus and later for obstructing lung cancer(these were for palliation since such patient have additional metastatic disease). However PDT is also approved for cure of early stage cancers of the lung and esophagus. In the most recent clinical trial for this latter indication a 5 year,77% cure rate was obtained ,saving these patients from having the diseased part of their esophagus removed surgically, a treatment with both high mortality(10 -30% of these patients die within 30 days of surgery) and more than 50% exhibit morbidity.PDT has none of these side effects.