|IMUC gets FDA Nod to start Phase II clinical trial|
|By Staff and Wire Reports|
|Tuesday, 04 January 2011 09:10|
ImmunoCellular Therapeutics, Ltd. (OTC.BB:IMUC.OB) the Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers which recently completed a Phase I trial of its lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor associated antigens for glioblastoma, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) amendment to conduct a Phase II clinical trial in the U.S. of ICT-107, the company's dendritic cell based cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM).
The double-blind, placebo-controlled, 2:1 randomized Phase II study is designed to evaluate the safety and efficacy of ICT-107 in patients with newly diagnosed GBM. The study will enroll approximately 100 patients and will be conducted at an estimated 15 clinical trial centers in the U.S. in collaboration with leading experts and opinion leaders in neuro-oncology.
In a recent interview with BioMedReports, Manish Singh, Ph.D. President and CEO of IMUC said the trial has important significance to his company: "We have done our best to design a phase II program that has the blessings of not only some of the key opinion leaders in brain tumors but also several pharmaceutical companies. The phase II design is like a mini phase III with a double blinded, randomized, and controlled trial which takes all the biases out. The big challenge to this study is going to be to ensure a fast accrual rate of patients which we are tackling by getting a number of top notch brain tumor specialists behind this clinical trial. If the data is anything close to what we have seen so far, this product would become the new standard of care and one of the biggest changes in treatment paradigm of brain tumors."
In the Phase I clinical study of ICT-107 in GBM, newly diagnosed patients who received the vaccine in addition to the standard of care of surgery, radiation and chemotherapy demonstrated a one year overall survival of 100 percent and a two year survival of 80 percent. This compares favorably with historical 61.1 percent one-year and 26.5 percent two-year survival based on the standard of care alone. The median overall survival has not yet been reached at over 30 months analysis point, with 11 out of 16 patients alive (69% percent).
The 12-month disease-free survival from the time of surgery was 75 percent with ICT-107, compared with the historical control of 26.9 percent, and the 24 month disease-free survival with ICT-107 was 43.8 percent, compared with 10.7 percent historically. The median progression-free survival (PFS) of 16.9 months after surgery compared especially favorably with the historical median PFS of 6.9 months observed with the standard treatment. Six of the 16 patients (37 percent) who participated in the study continue to live with no disease progression with an average time of over 30 months. Safety data for ICT-107 also compared favorably to current treatments: no serious adverse events were reported and minor side effects included fatigue, skin rash and pruritis.
As we have told readers in the past, IMUC is a worthy contender. It’s treatment candidate is similar to Dendreon’s Provenge in that it is also made by harvesting a patient’s own dendritic cells and programming them to attack cancer. But unlike Provenge, multiple doses of ICT-107 may be produced from a single batch of dendritic cells thanks to the company’s new manufacturing methods which were developed with the University of Pennsylvania. According to ImmunoCellular’s president and CEO Manish Singh, PhD, this proprietary manufacturing method will provide significant cost and convenience benefits over methods currently used to manufacture dendritic cell-based vaccines.As promising as ICT-107 is, ImmunoCellular is no one-trick pony. In its pipeline is an off-the-shelf vaccine targeting multiple antigens expressed by cancer stem cells, which is expected to begin Phase I testing early next year. The company is also developing a range of monoclonal antibodies with broad therapeutic and diagnostic applications.
Shares are currently trading at just over $1 with a 52 week range between $ 0.76 and $2.44 and with ImmunoCellular starting a Phase II clinical trial for ICT-107, we would expect that shares are also in a position to start climbing.