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Enrollment Of Phase II Clinical Trial Of ICT-107 Is Ahead Of Schedule

On Jan 23, ImmunoCellular Therapeutics, Ltd. (IMUC) provided an update on clinical trial site activity and patient enrollment for its Phase II clinical trial of ICT-107 for the treatment of glioblastoma multiforme (GBM).

The Company has initiated the trial in 23 centers and has received Institutional Review Board (IRB) approval from a total of 24 trial sites. The trial is expected to enroll approximately 160-200 patients to treat 102 patients with HLA-A1/A2 immunological subtypes. There are 115 patients enrolled in the study to date, ahead of the Company's schedule. Enrollment for the trial is expected to be completed by the second quarter of 2012 and an interim analysis is expected when 50% of events (32 deaths) have been observed.

As a reminder, the Company initiated the Phase II trial of ICT-107 for the treatment of newly diagnosed GBM following resection and chemoradiation in January 2011. The Phase II trial is a double-blind, placebo-controlled, 2:1 randomized study designed to evaluate the safety and efficacy of ICT-107 in patients with newly diagnosed GBM. The study is enrolling patients at medical institutions in collaboration with leading experts and opinion leaders in neuro-oncology at those sites.

Patients will receive at least four intradermal injections of the ICT-107 vaccine and additional doses of vaccine during a maintenance phase until disease progression. The primary objective is to compare overall survival (OS) and progression free survival (NYSE:PFS) in patients when treated with ICT-107 versus control.

The Phase I clinical study of ICT-107 in GBM, 16 newly diagnosed patients who received the vaccine in addition to standard of care of surgery, radiation and chemotherapy demonstrated two year overall survival of 80 percent and a three year survival of 55 percent. These figures compare favorably to the 26 percent two-year and 16 percent three-year survival based on the historical standard of care treatment alone. The median overall survival was 38.4 months compared to 14.6 months for the historical standard of care. The study's median progression free survival (PFS) of 16.9 months compared favorably to the historic median PFS of 6.9 months. Six out of the 16 (37.6%) newly diagnosed patients who received ICT-107 continue to show no tumor recurrence at the last analysis, with 3 of these patients (18.8%) remaining disease-free for more than 4 years while the other 3 patients had gone more than 3 years disease-free. There have been no serious adverse treatment related symptoms observed in any of the patients.

Phase I trial result summary

     

ICT107 + SOC*

 

SOC (Stupp, NEJM, 2005)

     

(n=16)

 

(n=287)

           
 

Median Age

 

52

 

56

           

PFS (%)

At 6 months

 

100

 

53.9

 

At 12 months

 

62.5

 

26.9

 

At 18 months

 

43.8

 

18.4

 

At 24 months

 

43.8

 

10.7

 

At 36 months

 

38.0

 

6.0

 

Median (months)

16.9

 

6.9

           

OS (%)

At 6 months

 

100

 

86.3

 

At 12 months

 

100

 

61.1

 

At 18 months

 

93.8

 

39.4

 

At 24 months

 

80.2

 

26.5

 

At 36 months

 

55.0

 

16.0

 

Median (months)

NR = 38.4

 

14.6

           

*SOC= Standard of Care (XRT +TMZ); NR=Not reached

Based on the positive Phase I clinical trial results, the probability of positive Phase II results is high. Unlike the Phase I which showed a 24-month increase in OS, a six-month increase in OS would be considered successful and clinically relevant for this disease as the current standard of care increases OS by 2.5 months. Upon the successful conclusion of the Phase II study, IMUC anticipates a lucrative partnering contract with a major pharmaceutical or biotech company. The partnership may include a large sum of upfront payment, milestone fees and high royalties.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.