|ImmunoCellular (OTC: IMUC.OB): Updated Presentation, Pending Catalysts|
|Friday, 02 October 2009 03:00|
The Phase 1 study for ICT-121 will involve 20 patients with glioblastoma (GBM is a deadly type of brain cancer) receiving five treatments each with final data from the trial anticipated after about 18 months (e.g. 3Q11), since the median time to recurrence in GBM patients is only 6.9 months. ICT-121 may also be beneficial to patients with pancreatic, lung, colon, renal, melanoma, and breast cancers.
Early next year (1Q10 which ends 3/31/10), IMUC expects to make an IND filing with the FDA for permission to begin human clinical trials for a Phase 1 study of its off-the-shelf cancer stem cell vaccine candidate (ICT-121). IND Filings for ICT‐121 are expected for Brain Tumors in US or Europe during 1Q10 while IND Filings for ICT‐121 for Pancreatic Cancer are expected in the US or Europe during 3Q10.
IMUC is developing a Dendritic Cell (DC) Based Cancer Antigen Vaccine (ICT‐107) to Treat Glioblastoma (GBM, the most common / aggressive form of brain cancer). A Phase I GBM trial was initiated in May 2007 with a goal of determining the safety and immune response of patients. The DC vaccine targets six glioma‐specific peptides including targets highly expressed on cancer stem cells. In the study, 19 patients (16 newly diagnosed and 3 recurrent) treated with no serious adverse events and patients received three vaccinations at two weeks apart.
In addition, 43% of newly-diagnosed patients experienced no tumor recurrence with median progression free survival (PFS) of 14.6 months versus just 6.9 months for the standard of care treatment for GBM. Overall PFS in the trial was 12 months while three patients experienced PFS / OS (overall survival) of greater than two years. Initial data was presented earlier this year at ASCO. No grade 3 or 4 toxicities were reported in the Phase 1 trial. The next update on clinical data will be reported at the Congress of Neurological Surgeons on 10/26/09. Potential partnering of ICT‐107 may occur in 2010 as IMUC to fund future clinical development as IMUC retains ICT-121 for in-house clinical development.
IMUC previously acquired a platform technology to create cancer monoclonal antibodies (mAbs) based on a differential immune response (DIAAD) methodology. IMUC is developing cancer‐specific mAb candidates targeting small cell lung cancer (SCLC), pancreatic, ovarian, colon cancers and multiple myelomas. ICT‐69 is being developed for multiple myeloma / ovarian cancer with an option license agreement with Roche (RHHBY.PK) that includes up to $32 million in payments and royalties announced on 9/9/09. On 9/30/09,
IMUC announced promising results from a pilot study evaluating the ability of the mAb (ICT-109) to distinguish between inflammatory conditions, cancerous, and non-cancerous tissue among pancreatic and lung cancer samples in the blood. ICT-109 was able to detect the pancreatic and lung cancer samples by binding to specific regions (glycosylated epitopes) of two common, over-expressed markers (CEA-CAM6 and CEA-CAM5) in a wide range of cancers. In addition, glycosylated CEA is over-expressed in patients with pancreatic / lung cancers and can be used to detect these cancers using a direct blood test. IMUC has guided for a potential partnering of ICT-109 during 2010 and will also continue to develop additional mAbs targeting cancer stem cells (CSCs).
The BioMedReports.com stock research section includes a report for IMUC published by Griffin Securities in April with a buy rating and $2.50 price target in addition to the most recent corporate presentation for October 2009. Click here to visit IMUC's page on Facebook to stay informed on the lastest updates and developments for the Company.
Disclosure: Long IMUC.OB
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