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Share Name | Share Symbol | Market | Type |
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EOM Pharmaceutical Holdings Inc (PK) | USOTC:IMUC | OTCMarkets | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.02895 | 18.68% | 0.18395 | 0.15 | 0.1979 | 0.1979 | 0.18395 | 0.1979 | 5,100 | 15:52:40 |
LOS ANGELES, June 1, 2014 /PRNewswire/ -- ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT:IMUC) announced that updated efficacy and safety data from the phase II trial of dendritic cell-based immunotherapeutic vaccine ICT-107 in patients with newly diagnosed glioblastoma multiforme (GBM) were presented at the 2014 American Society for Clinical Oncology (ASCO) annual meeting in Chicago.
When overall survival (OS) and progression-free survival (PFS) were assessed in pre-specified patient subgroups, results favored treatment with ICT-107 over control in HLA-A2 patients within each of the two major MGMT subgroups (unmethylated and methylated). While the subgroups were small in size, and not powered to show statistical significance, the numeric advantages in favor of ICT-107 treated patients were shown to be large and clinically meaningful.
HLA (human leukocyte antigens) are cell-surface antigen-presenting proteins. These molecules are on dendritic cells and present the tumor-associated antigens to T-cells to induce the immune response to the ICT-107 vaccine. HLA-A2 was one of two HLA types that were treated in the phase II trial. Of the two types, HLA-A2 is twice as common in the population as HLA-A1, and is the most common HLA type in North America and the EU.
In the per-protocol (PP) analysis of data from HLA-A2 patients with unmethylated MGMT:
In the PP analysis of data from HLA-A2 patients with methylated MGMT:
The updated data from the phase II ICT-107 trial were presented in an oral session by Patrick Y. Wen, MD, Director of the Center for Neuro-Oncology at The Dana Farber Cancer Institute and Professor of Neurology at Harvard Medical School, and principal investigator on the trial. The presentation was titled "A randomized, double‑blind, placebo-controlled phase 2 trial of dendritic cell (DC) vaccination with ICT-107 in newly diagnosed glioblastoma (GBM) patients."
"We think that the maturing data from the phase II trial demonstrate a compelling rationale for phase III development of ICT-107 in patients with newly diagnosed glioblastoma," said Dr. Wen. "Standard-of-care chemotherapy, temozolomide, has little or no treatment benefit for newly diagnosed GBM patients with unmethylated MGMT, which is the majority of patients. ICT-107 has shown the potential to meaningfully extend both OS and PFS without significant side effects in this patient population which has the poorest prognosis for survival. Furthermore, the early evidence of a potential long-term survival "tail," even in this small phase II trial, is promising, and indicative of what we would expect to see in a highly active immunotherapeutic agent. As the methylated MGMT group is followed further, I am optimistic that the already very large increase in PFS for treated patients ultimately may translate into a survival benefit."
"The pre-specified subgroup analyses in our phase II trial indicate the potential value of a targeted population approach going forward, as the demonstration of treatment benefit in HLA-A2 patients presents a favorable case for selecting these patients for the population to be studied in phase III clinical testing," said Andrew Gengos, ImmunoCellular's Chief Executive Officer. "HLA-A2 patients comprise the majority of the overall GBM patient population in the US and Europe. These new results will provide a strong basis for conducting registration discussions with US and EU regulatory authorities, which we intend to start within the next few months. We want to express our appreciation to the patients, investigators and clinical teams who have participated in the ICT-107 phase II trial. We look forward to potentially advancing this promising cancer vaccine toward the market."
Additional Updated ICT-107 Phase II Results
As reported in December 2013, and in the updated data presented at ASCO, OS for the ITT and PP populations showed a numeric, but not statistical, treatment benefit. PFS for the ITT and PP populations showed a statistical treatment benefit.
Assessment of Additional Trial Parameters
Data on quality of life as well as certain immunological parameters, including vaccine potency and antigen expression, were also presented.
Next Steps in the ICT-107 Program
ImmunoCellular plans to consult further with the international neuro-oncology community, and to hold regulatory agency discussions in both the US and EU concerning ICT-107.
The Company is in the process of finalizing the design of the phase III protocol, in anticipation of discussions with the FDA and the European Medicines Agency, or EMA. Plans are underway to request an end-of-phase II meeting with the FDA, anticipated to take place during the summer. Following typical European protocol in preparation for meeting with the EMA, ImmunoCellular has requested advice meetings at the national level in Germany, the UK and the Netherlands to discuss ICT-107. These meetings are scheduled to take place later in June. In the third or fourth quarter of 2014, the Company plans to seek advice from the EMA on the approval process for ICT-107.
ImmunoCellular also plans to continue to monitor patients in the phase II trial and update the data analysis at upcoming scientific meetings, such as potentially the Society for Neuro-Oncology (SNO) meeting in November.
About the ICT-107 Phase II Trial
The ICT-107 phase II trial is a randomized, double-blind, placebo-controlled phase II study of the safety and efficacy of ICT-107 in newly diagnosed patients with glioblastoma multiforme following resection and chemoradiation. ICT-107 is an intradermally administered autologous vaccine consisting of the patient's dendritic cells pulsed with six synthetic tumor-associated antigens: AIM-2, MAGE-1, TRP-2, gp100, HER-2, IL-13Rα2. The control consists of the patient's unpulsed dendritic cells.
A total of 124 patients were randomized at 25 clinical trial sites in the US. One third of the patients or 43 patients were treated with placebo (their own dendritic cells not exposed to antigen), and the treatment arm included two thirds or 81 patients who received the ICT-107 vaccine. All patients in the trial received standard-of-care temozolomide. The regimen is four induction doses of ICT-107 after chemoradiation, and then maintenance doses until the patient progresses. The primary endpoint of the trial is OS, defined as the time from randomization until date of death or the last date the patient is known to be alive. Secondary endpoints include PFS, defined as the time from randomization until the date of documented progressive disease or death, whichever occurs first, or the last date the patient is known to be alive and progression-free if progression or death is not observed. Other secondary endpoints include the rates of OS and PFS at six months after surgery, then assessed every three months until the end of the study. Safety and immune response are additional secondary endpoints.
The subgroups analyzed in the phase II trial were based on age, gender, HLA type, MGMT status, performance status and resection status.
HLA-A2 patients comprised about 62% of all patients randomized in the trial, meaning that these numeric and statistical outcome benefits were conveyed to a majority of treated patients.
MGMT status has been demonstrated to be predictive of response to radiation or chemotherapy. The O(6)-methylguanine-DNA methyltransferase, or MGMT, gene is responsible for a DNA repair mechanism in cells. Methylation of MGMT impedes the DNA repair mechanism in cancer cells, making them susceptible to radiation or chemotherapy, such as temozolomide. The DNA repair mechanism in cancer cells with unmethylated MGMT is intact, enabling them to survive and proliferate. GBM is the most common and aggressive primary cancer of the brain. Patients with this disease have few therapeutic options; temozolomide is currently the only FDA-approved systemic chemotherapy for newly diagnosed GBM.
For patient-related information about the ICT-107 clinical program in glioblastoma, please visit the ImmunoCellular website at www.imuc.com and access the ICT-107 "Frequently Asked Questions." The email address to contact the company directly is clintrials@imuc.com.
About ImmunoCellular Therapeutics, Ltd.
ImmunoCellular Therapeutics, Ltd. is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. ImmunoCellular is conducting a phase II trial of its lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor-associated antigens for glioblastoma. ImmunoCellular's pipeline also includes ICT-121, a dendritic cell vaccine targeting CD133, and ICT-140, a dendritic cell vaccine targeting ovarian cancer antigens and cancer stem cells. To learn more about ImmunoCellular, please visit www.imuc.com.
Forward-Looking Statements for ImmunoCellular Therapeutics
This press release contains certain forward-looking statements that are subject to a number of risks and uncertainties, including the risk that ICT-107 can be further successfully developed or commercialized, the timing and outcome of the post-phase II meeting with the FDA and EU regulatory authorities, the status of the current data and whether further analyses or later studies may confirm the successful PFS results to date, the potential for initiation of phase III trials and possibility of successful results from such studies. Additional risks and uncertainties are described in IMUC's most recently filed quarterly report on Form 10-Q and annual report on Form 10-K. Except as permitted by law, IMUC undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. In this press release, you can identify forward-looking statements by terms such as "may," "will," "should," "could," "would," "expect," "plan," "anticipate," "believe," "estimate," "project," "predict," "potential," "future," "intend," "certain," and similar expressions intended to identify forward-looking statements.
Contact:
ImmunoCellular Therapeutics, Ltd.
Investor Relations
Jane Green
415.348.0010 direct
415.652.4819 mobile
jane@jmgcomm.com
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SOURCE ImmunoCellular Therapeutics, Ltd.
Copyright 2014 PR Newswire
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