80% 2-Jahres-Überleben beim Glioblastom durch ICT-107

[Olli]

In einer Phase-I-Studie zu ICT-107 hat ImmunoCellular mittels einem Vakzin 1-Jahres-Überlebensraten von 100% und 2-Jahres-Überlebensraten von 80% beim neu diagnostizierten Glioblastom erzielen können. Die genauen Daten sollen auf der ASCO präsentiert werden, die dieses Wochenende stattfindet.
Hier die Pressemitteilung:

ImmunoCellular Therapeutics, Ltd. (OTC.BB: IMUC ) , a biotechnology company focused on the development of novel immune-based cancer therapies, today announced that data from a recent clinical trial of ICT-107, the company’s dendritic cell based cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM), will be presented at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) being held June 4-8 in Chicago. The presentation, “Immune response correlation with progression-free survival in glioblastoma following dendritic cell immunotherapy (ICT-107),” features data showing ICT-107 provided a significant increase in survival in patients who received the vaccine.

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 the 26.4 months analysis point, with 12 out of 16 patients alive (75% 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 18-month disease-free survival with ICT-107 was 49.2 percent, compared with 18.4 percent historically. The median progression-free survival (PFS) of 17.7 months after surgery compared especially favorably with the historical median PFS of 6.9 months observed with the standard treatment. Seven of the 16 patients (44 percent) who participated in the study continue to live with no disease progression with an average time of over 29 months. Safety data for ICT-107 also compared favorably to current treatments: no serious adverse events were reported and minor side effects were limited to fatigue, skin rash and pruritis.

“These new data further establish ICT-107 as a promising potential treatment for glioblastoma, a disease for which there are currently few and limited treatment options,” said Surasak Phuphanich, M.D., Director of the Neuro-Oncology Program at Cedars-Sinai Medical Center. “We are excited for what these data mean for patients, the medical community, and the field of immunotherapy as a whole. We look forward to further investigating ICT-107 in additional clinical studies.”

Quelle: http://www.imuc.com/press/June0210-Immu ... ients.html

[Olli]

In den USA geht wenigstens etwas voran, ICT107 hat den Orphan Drug Status durch die FDA erhalten:

ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for ICT-107, the company’s dendritic cell-based cancer vaccine candidate which targets glioblastoma multiforme (GBM). As a result of the orphan drug status, ImmunoCellular will be eligible to receive a number of benefits, including access to grant funding for clinical trials, tax credits, accelerated FDA approval and allowance for marketing exclusivity after drug approval for a period of up to seven years. US orphan drug designation is granted to companies with products aimed at treatment of a rare disease or condition that affects fewer than 200,000 Americans.

A recent Phase I clinical study of ICT-107 in GBM revealed that newly diagnosed patients who received the vaccine demonstrated a median progression-free survival (PFS) of 17.7 months after surgery, compared with the historical median PFS of 6.9 months observed with standard treatment with surgery, radiation and chemotherapy. Seven of the 16 patients (44%) who participated in the study went on to live with no disease progression with an average time over 2 years, significantly better than historical data of less than 15% disease free survival. The drug has exceeded its competitors in the overall survival rate in newly diagnosed GBM patients by demonstrating an 80% survival, which is about three times larges than the historical control.

"We are pleased that FDA has recognized the potential that ICT-107 has to treat GBM and has granted us orphan drug status”, said ImmunoCellular Therapeutics’ president and CEO said Manish Singh, Ph.D. "The designation should facilitate a shorter time period to approval and reflects the FDA’s views on the importance of developing a treatment which will improve survival outcomes for those afflicted with this terrible disease."

Quelle: http://imuc.com/press/June1110-ImmunoCe ... T-107.html

[ch233]

Dazu folgendes Update:

ImmunoCellular Therapeutics Announces Updated Long-Term Disease-Free Survival Data from Phase I Study in Glioblastoma
May 5, 2011
LOS ANGELES, CA – ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular" or the "Company") (OTCBB: IMUC), a biotechnology company focused on the development of novel immune-based cancer therapies, today announced updated long-term data from a Phase I clinical trial of ICT-107, the Company's lead cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. The data show 6 out of 16 (37.6%) newly diagnosed patients who received ICT-107 continue to show no tumor recurrence, with 3 of these patients (18.8%) remaining disease –free for almost four years while the other 3 patients have gone more than two and a half years disease-free. No new patients have shown disease recurrence since the last report of data in September, 2010. No treatment-related serious adverse events have been observed to date. (...)

Quelle: http://www.imuc.com/imuc-05-05-2011

The Phase I clinical study was conducted in 16 newly diagnosed glioblastoma patients, who received three injections of ICT-107 in addition to standard treatment with surgery, radiation and chemotherapy. The company has reported two year median survival rate of 80.2% in study patients, which compares favorably to the historic median two-year survival rate of 26.5% with standard of care alone. The study's median progression free (PFS) survival of 16.9 months compared especially favorably to the historic median PFS of 6.9 months. 10 of the 16 patients continue to survive. No serious adverse events have been reported and minor side effects have been limited to fatigue, skin rash and pruritis. (...)

Quelle: http://www.imuc.com/imuc-05-05-2011
Quelle: ImmunoCellular Therapeutics, Ltd.

[ch233]

Hier ist der Link zur Studie (Phase 2):

http://www.clinicaltrials.gov/ct2/show/ ... 107&rank=1

Laut Angaben der Website werde aktuell (07.06.2011) noch Teilnehmer (Patienten) rekrutiert.

[ch233]

Meldung vom 10.06.2011

ImmunoCellular Therapeutics Ltd. weitet klinische Studie (Phase 2) von ICT-107 aus:

The Company had initially planned to conduct the study, which is now underway, at up to 15 clinical centers, but has increased the number of anticipated sites to 20 or more. ImmunoCellular has qualified 21 sites so far and has submitted the trial to 12 prospective sites' Institutional Review Board (IRB) for approval. Of these 12 sites, 6 have received their IRB approval.

"We are excited to accelerate and expand site enrollment of our Phase II clinical trial for ICT-107," said Manish Singh, Ph.D. president and CEO of ImmunoCellular Therapeutics. "With this trial we look forward to generating data in support of the safety and efficacy of ICT-107 in the treatment of GBM and to further support the promising outcomes reported in our Phase I study."

Quelle:
http://www.medicalnewstoday.com/releases/228180.php
ImmunoCellular Therapeutics, Ltd.

[ch233]

Meldung vom 17.06.2011
Quelle: Medical News Today - http://www.medicalnewstoday.com/releases/228885.php


Titel: Drug Targets Six Antigens Found In Brain Tumors And Three Found In Cancer Stem Cells, Prolonging Survival

Basierend auf folgender Veröffentlichung: "Glioma associated antigens associated with prolonged survival in phase I study of ICT-107 for patients with newly diagnosed glioblastoma," (Abstract No. 2042) poster presentation at American Society of Clinical Oncology (ASCO) annual meeting, June 4, 2011

In this Phase I clinical trial that started in November 2006, 11 of 16 patients (69 percent) were still alive at 32 months (a median analysis time); six of 16 (38 percent) continued to be disease-free; three have gone almost four years and another three have survived more than 2.5 years with no recurrence. Median progression-free survival - the time from treatment to disease recurrence (median progression-free survival) was 16.9 months.

Phase I trials generally address dosage and safety issues. To further evaluate survival statistics, a randomized, multicenter, placebo-controlled Phase II trial has been launched.

ICT-107 targets six antigens found on glioblastoma cells, three of which also are found on cancer stem cells. Those cells widely are believed to be the original source of tumor cells, enabling them to resist treatment and recur. The study revealed that all 16 patients had at least three of the targeted antigens and 75 percent had all six. Patients who had four of the antigens (MAGE-A1, AIM2, gp100 and HER2) had better immune responses and longer progression-free survival rates.

Surasak Phuphanich, MD, director of the Neuro-Oncology Program of the Department of Neurosurgery and the Department of Neurology at Cedars-Sinai, termed another finding significant: levels of a protein associated with cancer stem cells (CD133) decreased in patients who had tumor recurrence after vaccination.

"Previous studies showed an increase in CD133 expression in patients who underwent treatment with radiation and chemotherapy. Our findings suggest that targeting antigens that are highly expressed by cancer stem cells may be a viable strategy for treating patients who have glioblastoma," he said

Quelle: Sandy Van
Cedars-Sinai Medical Center

[ch233]

Habe einen sehr informativen Nachrichtenbeitrag von CBS über ICT-107 gefunden:

http://youtu.be/2EFL2TVSZzk

June 7th 2011 - Vaccine for brain tumor