'If Oncosil were to work in HCC, then I think the technical ease of administration may be a positive over Sirtex spheres especially in less developed countries. However, trials are needed and that will take time and money.'
Correct. Trial that runs into many hundreds of pts will be required, an that can take severla years.
Secondly, I not sure how an injection will be performed in HCC. The link below shows a very dramatic response to TARE, or SIRT. Note the size of the tumor being > 8cm. With the expected penetration of OSL treatment there would be serious other organ radiation absorption if the injection was too high in the tumor. Besides a single injection would do little with tumors of this size, imo.
There may be applications in HCC, but SH should be aware that this really is flying a kite at this stage.
But just for one minute lets assume that a phase 1 trial on half a dozen pts showed some reasonable data. By the time this data was ready, SRX would have released the data from European and Asian large trials for HCC.
If their trials fail to improves OS, then the willingness for centres to trial another radiation may be somewhat less, and thus a phase 2 may take considerably longer.
On the other hand, if the SRX trials do show OS improvment of 4 months or more then they will become SOC in HCC. Should this come to pass then OSL would have to trial against SRX.
Either way, this is a 4-7 year process.
http://www.cureus.com/articles/3896...90-based-selective-internal-radiation-therapy
Worth going to the link to see scan images - very impressive!
Abstract
Hepatocellular carcinoma (HCC) is predominantly diagnosed in advanced stages and not amenable to surgical resection and transplantation. Systemic therapies have had a limited efficacy in treating HCC. Although HCC is a radiosensitive tumor, treatments with external-beam radiation are limited by radiosensitivity of normal liver tissue and surrounding organs-at-risk, i.e. bowel, stomach, and kidney. Several large retrospective series have demonstrated a modest effect of selective internal radiation therapy (SIRT) with Yttrium-90 (90Y) microspheres in unresectable HCC, both in terms of tumor response and survival. The authors present a patient with an extremely large, multifocal, unresectable HCC who achieved a dramatic response with SIRT treatment.
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PARADIGM BIOPHARMACEUTICALS LIMITED..
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