SHANGHAI, China and CUPERTINO, Calif., Nov. 03, 2015 (GLOBE NEWSWIRE) -- Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG” or the “Company”), a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases, today responded to inquiries from investors and the scientific community about the announced results from an ongoing Phase IIa clinical trial evaluating the safety, feasibility and anti-tumor activity of its acquired Chimeric Antigen Receptor-Modified T-Cells (CAR-T) immunotherapy (CBM-CD20.1) targeting CD20 for the treatment of patients with advanced B-cell Non-Hodgkin lymphoma (NHL).
What are the significant treatment differences between the Phase I and Phase IIa studies?
The Phase IIa study excluded patients with uncontrolled bulky lymphoma (maximum diameter ≥5 cm or lesion number >3) after salvage treatments. The object of the early Phase IIa study is to evaluate the clinical activity of CBM-CD20.1 in NHL patients refractory or relapsed after chemotherapy. We also want to evaluate whether CBM-CD20.1 might improve the clinical outcome of advanced NHL patients that respond partially to chemotherapy. There will be a more detailed discussion in an upcoming manuscript in a peer-reviewed journal.
Please clarify how many patients actually enrolled in this Phase IIa NHL trial?
Fifteen patients were screened and twelve patients were enrolled. Of the twelve patients enrolled, two patients did not proceed with cell infusion. One withdrew consent and the other had disease progression and did not meet the inclusion criteria. Nine of the ten patients were refractory or relapsed after chemotherapy. The tenth patient showed partial response to most recent chemotherapy.
The abstract published by the 4th International Conference on Translational Medicine held in Baltimore on October 26-28th discussed an 11th patient from the Phase I trial. This patient remained in complete remission for over 25 months since the initial treatment of CBM-CD20.1, and the response is still on going. This patient was given a second treatment of CBM-CD20.1 infusions at 16 months post initial treatment based on the significant decrease of CD20 CAR-T cells in the peripheral blood (“Patient X”). In congruence with study protocol, we did not include Patient X in our presentation. The presented data of the 10 patients (seven patients with diffuse large B-cell lymphoma (DLBCL) and three patients with other types of NHL) from the Phase IIa trial can be viewed on the Company website under Investor Relations/Presentations.
How many of the patients who participated in the original Phase I trial enrolled in the Phase IIa study?
None of the ten patients reported in the Company’s October 28th press release had participated in the original Phase I trial.
Please provide rationale on why the Phase II study result is substantially better than that of the Phase I study.
Besides excluding patients with uncontrolled bulky lymphoma, there were improvements in the conditioning regimen and treatment protocol, as well as the CBM-CD20.1 CART production process. Together these contributed to the improved clinical outcome in the phase IIa results.
What is the Company’s next step on targeting CD20 for the treatment of NHL?
The company intends to seek an opportunity to confirm the safety and clinical efficacy of CBM-CD20.1 in advanced NHL in a multicenter, single arm, Phase IIb trial. We plan to also explore other opportunities such as repeated treatment of CBM-CD20.1 or combination with other immuno-oncology therapies in advanced NHL.
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of certain degenerative and cancerous diseases. Our developmental stem cell and Immuno-Oncology projects are the result of research and development by scientists and doctors from China and the United States. Our flagship GMP facility in China, consisting of nine independent cell production lines, is designed, certified and managed according to U.S. standards. To learn more about CBMG, please visit: www.cellbiomedgroup.com
Forward-Looking Statements
Statements in this press release relating to plans, strategies, trends, specific activities or investments, and other statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include risks inherent in doing business, trends affecting the global economy, including the devaluation of the RMB by China in August 2015 and other risks detailed from time to time in CBMG’s reports filed with the Securities and Exchange Commission, quarterly reports on form 10-Q, current reports on form 8-K and annual reports on form 10-K. Forward-looking statements may be identified by terms such as “may,” “will,” “expects,” “plans,” “intends,” “estimates,” “potential,” or “continue,” or similar terms or the negative of these terms. Although CBMG believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. CBMG does not have any obligation to update these forward-looking statements other than as required by law.