ImmunoCellular Therapeutics Issues Letter to Shareholders, Highlighting Progress on Advancing ICT-107 to Phase 3 Registrational Trial
To Our Shareholders:
As we work toward building a leading cancer immunotherapy company, the management and board of directors of
- ICT-107 is advancing to its final stage of development. Reaching agreement with the
FDAon the Special Protocol Assessment is a significant achievement and means we have lower regulatory risk than completing phase 3 without this up-front FDAreview. To our knowledge, ICT-107 will be the only therapy currently in phase 3 testing for newly diagnosed glioblastoma with this advantage.
- Since our oral presentation at ASCO in 2014, in which our analysis of the phase 2 results identified the patient population that appears to benefit from ICT-107, management has delivered on a set of critical milestones in the areas of regulatory, manufacturing, trial design and trial execution.
- We are positioned to initiate clinical trial sites within 3 months in the US, with plans to enroll the first patient in the trial soon thereafter.
In addition to advancing the ICT-107 program, we are establishing a research capability based on our Stem-to-T cell platform, which originated at Caltech.
- Achieving T cell killing of tumors based on an engineered stem cell therapy has potential advantages over T cell cancer immunotherapy approaches.
- We are working to establish key research collaborations with experts in the field to obtain pre-clinical proof of concept for this platform technology.
- While ICT-107 advances through phase 3, we intend to generate a pipeline of programs from this exciting technology and potentially from other adjacent technologies we are evaluating for in-license or acquisition.
In the future, we plan to continue to communicate our achievements, and will look forward to announcing the start of the phase 3 program. We also are working to evaluate options for continued financing of the phase 3 trial. Finally, our Board, focused on identifying and appointing qualified candidates, intends to remedy our non-compliance with the
We cannot control external market conditions or the volatility of the stock market. We are endeavoring to bring a potential clinically meaningful treatment to patients in need and, in doing so, seeking to build shareholder value. That is what we are working to achieve every day.
President and Chief Executive Officer
Forward-Looking Statements for
This press release contains certain forward-looking statements, including statements regarding the development and commercialization of ICT-107, initiation of a phase 3 study of ICT-107, the advancement of the ICT-121 phase 1 trial, the development of our preclinical Stem-to-T-cell program and our ability to achieve our other clinical, operational and financial goals. These statements are based on
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