Nov. 20, 2015, 12:17 PM
- Nano cap ImmunoCellular Therapeutics (IMUC -13.3%) slumps on triple normal volume in response to its announcement of results from a mid-stage study of lead product candidate ICT-107 in patients with brain cancer (glioblastoma). The data are being presented at the 20th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology in San Antonio, TX.
- In the 124-patient intent-to-treat population, median overall survival (OS) in patients receiving ICT-107 was only 10% better than placebo and fell short of statistical significance.
- In a pre-specified subgroup, those seropositive for HLA-A2 (human leukocyte antigen alpha 2), which helps the immune system detect and attack cancer cells, the positive effect from ICT-107 was more profound. In a group categorized as MGMT methylated, those receiving ICT-107 experienced median OS of 13.8 months or 58% better than placebo. In MGMT unmethylated subjects, median OS was 4.0 months or 34% better than placebo. MGMT methylation is associated with improved response to radiation and chemotherapy. Neither difference achieved statistical significance, though, because they were not powered to do so.
- In HLA-A2+ patients, 60% of those in the ICT-107 cohort showed a statistically significant immune response versus 36% for placebo (an immune response is associated with survival). In addition, those treated with ICT-107 experienced a statistically valid survival benefit (p=0.0084). Immune response was similar in the MGMT methylated and unmethylated groups.
- Based on these data, the company's Phase 3 design will target HLA-A2+ patients, both MGMT methylated and unmethylated. The randomized, double-blind, 400-subject, placebo-controlled trial will commence shortly. The primary endpoint will be OS. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is December 2019. The estimated study completion date is December 2021.
Jul. 16, 2014, 12:37 PM
Jun. 2, 2014, 12:50 PM
Jun. 2, 2014, 9:16 AM
Feb. 25, 2014, 11:15 AM
- ImmunoCellular Therapeutics (IMUC +13.2%) says it has been granted orphan drug designation for ICT-107 for the treatment of patients with glioblastoma.
- Granting of orphan drug status in the EU provides sponsor companies with incentives, including a 10-year period of market exclusivity, access to a centralized review process, trial design assistance and scientific advice during product development, fee reductions, and tax incentives.
- IMUC already had received orphan designation for ICT-107 in glioblastoma in the U.S.
Feb. 25, 2014, 9:11 AM
Jan. 22, 2014, 12:47 PM
Jan. 22, 2014, 9:09 AM
Jan. 21, 2014, 12:47 PM
Dec. 24, 2013, 8:01 AM
- Shares of ImmunoCellular (IMUC) are trading sharply higher in premarket action.
- Notably, the company provides a bit of commentary on ICT-107 which, investors will recall, was behind a dramatic decline in IMUC's shares earlier this month when the OS K-M curves failed to hit statistical significance in a Phase 2 study.
- IMUC says it "urges patients and other stakeholders to look beyond the unsubstantiated commentary on the recent trial results to what [the company] and clinical experts believe are important findings from this clinical program to date."
- Further, IMUC says "nationally renowned neuro-oncologists ... share [the company's] view that as the survival data mature in 2014, there is the potential to see clarification of the survival benefit of the ICT-107 treated group." (PR)
- IMUC +20% premarket
Dec. 16, 2013, 12:46 PM
Dec. 12, 2013, 12:52 PM
Dec. 12, 2013, 9:11 AM
Dec. 11, 2013, 4:23 PM
- ImmunoCellular (IMUC) collapses 50% AH.
- The company is out with results from a Phase 2 study of ICT-107 in newly diagnosed glioblastoma multiforme.
- ICT-107 showed statistically significant PFS superiority over placebo. K-M curves (entire sample of 124 patients): Favors ICT-107; HR of 0.56; p=0.014; median PFS increase was two months. K-M curves (per-protocol population): Favors ICT-107; HR of 0.53; p=0.0074; median PFS increase was three months.
- OS K-M curves fail to hit statistical significance. OS was the primary endpoint. Summary (intent-to-treat): HR of 0.87; p=0.58. Summary (per-protocol): HR of 0.79; p=0.40.
- For more, see here.
Nov. 25, 2013, 5:42 PM
Nov. 25, 2013, 2:03 PM
- ImmunoCellular Therapeutics (IMUC +22.9%) rallies hard after Cedars-Sinai provides an update on a study of ICT-107 in glioblastoma multiforme.
- Eight of sixteen patients survived for longer than five years post-diagnosis.
- Six patients were progression free at five years.
- Four patients are still free of disease with "good quality of life at lengths from 65.1-82.7 months following diagnosis." (PR)
- As for the Street's take: Roth adds IMUC to its Focus List. Price target is $9.
ImmunoCellular Therapeutics Ltd. is a Los Angeles-based clinical-stage company that develops immune-based therapies for the treatment of brain and other cancers. ImmunoCellular's pipeline includes: ICT-121, a dendritic cell immunotherapy targeting the CD133 antigen on stem cells in recurrent... More
Industry: Medical Instruments & Supplies
Country: United States