OncoSec Medical (OTCBB:ONCS) said Wednesday that its OncoSec Medical System delivery devices have been qualified for safety, and are now ready for shipment to clinical sites in time for its upcoming electroimmunotherapy clinical cancer trials.
Shares of OncoSec jumped over 21%, to trade at $0.40 as of 2:06pm EDT Wednesday.
The company develops electro-oncology therapies to treat solid tumour cancers. In March, it acquired the rights to an electroportation delivery technology platform that can be used to deliver chemotherapeutic or DNA-based cytokine agent for cancer treatment, which OncoSec branded as the OncoSec Medical System (OMS).
Since then, projects were initiated to establish engineering and manufacturing capabilities, as well as, transfer and update regulatory, design and manufacturing documentation, including implementing a new quality assurance system for the devices.
Over the course of five months, the company said a manufacturing plan was executed to ensure that the devices acquired by OncoSec were safe and ready for use in clinical trials.
The company plans to initiate three phase two clinical trials using the OMS ElectroImmunotherapy treatment approach for melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma by the end of October.
OncoSec said it now has enough inventory of OMS devices to support clinical study requirements through to 2013. Its manufacturing operations allow the company to maintain the current device supply, scale up production as needed, as well as design and develop a newer OMS system.
"Since acquiring the technology our team has worked diligently to test, and re-test, the OMS device to ensure that it is safe and ready for in-human use, as well as, manufacture new applicators and applicator handles for the OMS ElectroImmunotherapy(TM) clinical trials," said OncoSec's chief business officer, Dr. Michael Cross.
"I am delighted to report that they are now ready for shipment to the clinical sites.
"This milestone also highlights the fact that OncoSec now has the in-house capabilities to build, maintain and develop our own devices, while still having the flexibility to outsource specific manufacturing activities, where required, thereby allowing OncoSec to hold strict control over manufacturing costs."
President and CEO, Punit Dhillon, added: "The release of these devices is an integral step in our development plan. With the achievement of this milestone, we continue to meet the goals set out by our corporate strategy, and expect to move toward validating the data seen in the Phase I study in our upcoming clinical trials."
OncoSec's system works through the targeted local delivery of chemotherapeutic agents, designed to selectively destroy cancerous tumors while sparing healthy normal tissue, resulting in improved quality of life outcomes. The treatment has shown validating safety and efficacy data in early and late stage clinical studies of over 400 cancer patients, the company said.
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