February 26, 2013

$PVCT: @MaverickNY: TLS, what is it and why is it important to cancer research

Around mid-February a reader of this blog asked about Tumor Lysis Syndrome ("TLS") in the context of PV-10. He forwarded me the link to Dr. Sally Church's blog's article about TLS. This topic was raised because AbbVie suspended 5 clinical studies for experimental leukemia and lymphoma medicine because patients died from tumor lysis syndrome ("TLS").

Pieter Droppert wrote:
Dr. Church wrote:

I do not think this is an issue for PV-10, but I learned quite a lot by exploring the topic and delving further into what makes Provectus' drug unique. The generation of too much necrotic tissue at one time is not good. It is important to manage tumor burden with the ablation of PV-10. Thus far, debulking was taken care of before patients were treated with PV-10 through surgical excision. As PV-10 is used in different stages of disease, however, physicians should take a balanced approach, making sure the entire tumor burden of the patient is properly treated. For example, a patient may have some surgical excision depending on tumor size, and then be treated with PV-10 for the remainder of the disease. Or, his or her tumor burden could be treated over a period of time with PV-10.

One key to PV-10's unique ability to very effectively treat local and distant cancer lies in the intratumoral delivery of the drug. This intratumoral route helps generate the remote response or bystander effect.

Systemic delivery, according to Craig, is what's wrong with chemotherapy. This route creates bad side effects, generates poor efficacy, and kills anti-tumor immunity, induces tolerance or shuts it off entirely.

Provectus has been careful about the size of tumor that would or should addressed by PV-10 because of the very issue of overwhelming a patient with dead tissue, which is a topic well known in medical literature (including, for example, literature related to radiofrequency ablation). Dosing, for example, plays an important role. A successful approach requires understanding several factors, among them the amount of necrotic tissue generated by PV-10 in different situations and under different scenarios, toxicity, etc. How much tumor you kill immediately versus over time not only influences dosing, but it also influences treatment approach.

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