Regenerative Therapy

Adoptive cell therapy for metastatic melanoma patients
Adoptive cell therapy is provided as experimental treatment for metastatic melanoma patients at the Ella Institute, the Sheba Medical Center, Israel.
Along with other advanced technologies, eligible patients are offered the advanced immunotherapy treatment with TIL (tumor infiltrating lymphocytes).This treatment was developed at the National Institute of Health, US, and very encouraging clinical results have been published by both institutions in the US and Israel*.
*
1. Clin Cancer Res. 2011 17:4550-7.
Durable …

Phase II study to examine survival, safety, and the magnitude of the immune response induced following administration of DN24-02 in subjects with HER2+ urothelial carcinoma.
Bladder cancer
Renal pelvis cancer
Ureteral cancer
Urethral cancer
Vaccine consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated in vitro with a recombinant fusion protein.
Multi center study in several sites in the US. October 2011 recruiting patients.
Clinical trials website:
http://clinicaltrials.gov/ct2/show/NCT01353222?term=dendreon&rank=3
Company website:
http://www.dendreon.com/

First report on potentially successful treatment of advanced colorectal cancer with autologous, genetically engineered T cells, reported by the group of Steve Rosenberg at the NIH, US.
PubMed citation:
Mol Ther. 2011 Mar;19(3):620-6. Epub 2010 Dec 14.
T cells targeting carcinoembryonic antigen can mediate regression of metastatic colorectal cancer but induce severe transient colitis.
Parkhurst MR, Yang JC, Langan RC, Dudley ME, Nathan DA, Feldman SA, Davis JL, Morgan RA, Merino MJ, Sherry RM, Hughes MS, Kammula US, Phan GQ, …

Young TIL Clinical Trial – Immunotherapy Program Milwaukee
A short clip by the group at Aurora-St. Luke’s Medical Center, Milwaukee, describing the “Young TIL” adoptive cell therapy program for treatment of metastatic melanoma:
http://youtu.be/GXP05PW1_MQ

The most significant case for disease eradication after adoptive cell therapy is the TIL treatment.
A recent review summarizes the clinical data: Nat Rev Clin Oncol. 2011 Aug 2. Cell transfer immunotherapy for metastatic solid cancer-what clinicians need to know. Rosenberg SA; Medscape.
“Cancer immunotherapy using the adoptive transfer of autologous tumor-infiltrating lymphocytes results in objective cancer regression in 49-72% of patients with metastatic melanoma. In a pilot trial combining cell transfer with a maximum lymphodepleting regimen, …

Two publications on novel approach for treatment of chronic lymphoid leukemia by autologous engineered T lymphocytes – clinical data for one (1) or three (2) patients.
Published in: 
1. New England Journal of Medicine:
“Chimeric Antigen Receptor–Modified T Cells in Chronic Lymphoid Leukemia”
David L. Porter, M.D., Bruce L. Levine, Ph.D., Michael Kalos, Ph.D., Adam Bagg, M.D., and Carl H. June, M.D.
August 10, 2011
http://www.nejm.org/doi/full/10.1056/NEJMoa1103849?query=featured_home
2. Sci Transl Med 2011:
Vol. 3, Issue 95, p. 95
“T Cells with Chimeric Antigen Receptors Have Potent Antitumor …

TxCell receives approval for a phase I/II clinical trial in rheumatoid arthritis
The study will evaluate safety and efficacy of the administration of TX-RAD, a type 1 regulatory T cell based immunotherapy, in patients with moderate to severe rheumatoid arthritis, who failed current treatments.
The planned study is an open label, 12 weeks multicenter phase I/II clinical trial.

The Tr1 cells utilized in TX-RAD are isolated from whole blood of the patient and activated by the specific antigen. The …

TxCell announces positive preliminary results from the phase I/IIa clinical trial of OvaSave(R) in Crohn’s disease
Phase I/IIa clinical trial:
Multicenter, open label, uncontrolled and dose-escalation Phase I/IIa study is designed to evaluate the safety and efficacy of OvaSave® therapy in patients with severe and relapsing Crohn’s disease. The product is injected intravenously as a single administration to patients with chronic active Crohn’s disease. Six sites in France enrolled patients distributed into 4 different cohorts with cell …

A dendritic cell vaccine personalized for each individual based on the patient’s own tumor was reported to increase median survival time in  glioblastoma patients. An early phase study at UCLA’s Jonsson Comprehensive Cancer Center.
The study found that the vaccine, administered after the conventional treatments of surgery and radio-chemotherapy, was associated with a median survival of 31.4 months, double the 15 months of historical controls in the published literature. 23 patients were enrolled in the Phase I …

Multikine® is a patented defined mixture of biologically active, natural cytokines that simulate the body’s healthy immune response. The cytokine mixture includes interleukins, interferons, chemokines, and colony-stimulating factors.
Planned Study Summary: A Pivotal Phase III, Open-label, Randomized, Multi-center Global Study of the Effects of Multikine Plus Standard of Care (Surgery + Radiotherapy or Surgery + Concurrent Chemoradiotherapy) in Subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity Versus Standard of Care Only. The goal …