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Tuesday, June 30, 2015 11:14:42 PM
Q: What other milestones do you hope to accomplish in 2015?
The major milestones for the remainder of 2015 are:
1. Complete the population of our Board of Directors with individuals who have extensive experience in life sciences and who have associated business expertise.
- Fully populate our Scientific Advisory Board with world-class physicians and scientists experienced in the fields of cancer and diabetes.
- Initiation of the Phase 2b clinical trial in Australia in patients with advanced pancreatic cancer. This is expected to begin in late 3Q2015.
2. Initiation of the Phase 1/2 clinical trial on the effectiveness of PharmaCyte’s pancreatic cancer treatment dealing with pain associated with advanced pancreatic cancer. This trial, to be conducted in the U.S., is expected to begin in late 3Q2015.
3. Initiation of the Phase 1/2 clinical trial on the effectiveness of PharmaCyte’s pancreatic cancer treatment in slowing the accumulation of malignant ascites fluid. This trial, to also be conducted in the U.S., is expected to occur in late 3Q2015 or early 4Q2015.
4. The initiation of these three clinical trials is dependent on the approval for use of the Cell-in-a-Box® live cell encapsulation facility that has been constructed in Bangkok, Thailand, by our partner, Austrianova. This facility must be approved as being compliant with current Good Manufacturing Practices (cGMP) standards by Thailand’s and Australia’s drug regulatory authorities as well as by the U.S. FDA.
5. Completion of our laboratory and small animal studies with the Melligen cells that are necessary to develop our treatment for insulin-dependent diabetes. These studies are designed to obtain data that will be required by regulatory authorities before any human clinical trials can occur.
http://www.biomedreports.com/20150518222991/qaa-with-pharmacyte-ceo-kenneth-l-waggoner-on-pmcbs-new-direction.html
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