Medicenna Amends Protocol of Phase 2b Recurrent Glioblastoma Study of MDNA55 in Response to Strong Safety Data and Early Efficacy Read-outs

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Title : Medicenna Amends Protocol of Phase 2b Recurrent Glioblastoma Study of MDNA55 in Response to Strong Safety Data and Early Efficacy Read-outs
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Medicenna Amends Protocol of Phase 2b Recurrent Glioblastoma Study of MDNA55 in Response to Strong Safety Data and Early Efficacy Read-outs

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"We are pleased with the safety profile to date and early efficacy signals of MDNA55. We are amending the protocol at the recommendation of our clinical advisors to further improve the chances for demonstrating increased therapeutic benefit for patients living with this life-threatening disease," said Fahar Merchant, PhD, President and Chief Executive Officer of Medicenna.

Principal Investigator, John H. Sampson MD, PhD, of Duke University Medical Center Department of Neurosurgery, commented, "The study has contributed substantially to the improvement of Convection Enhanced Delivery of drugs directly into brain tumors. More importantly, we are seeing definite biological effects of MDNA55 in some patients as we await final study results to see whether these translate into robust longer term benefits."

"We have used the occasion of this recruitment milestone to implement optimal methodologies in the amended protocol," commented Martin Bexon MD, Head of Clinical Development. "With the experience gleaned from the ongoing Phase 2b clinical trial of MDNA55 in rGBM, we are able, for instance, to allow for more personalized dosing based on the tumor load and incorporate advanced imaging modalities to measure treatment responses more reliably, despite significant changes due to necrosis and inflammation."  Additionally, the amendment will allow investigators to administer a second dose of MDNA55 where appropriate.


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