Glossary of terms
| Adult stem cells |
Stem cells sourced from adult donors. CellMed’s stem cells were derived from a single adult bone marrow donor and are stored and processed in a GMP-certified facility.
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| Alginate |
A biocompatible biomaterial derived from seaweed. CellMed’s proprietary alginate is an ultra-pure form designed to encapsulate and protect the stem cells from the patient’s immune system while allowing the GLP-1 to permeate out into surrounding tissue.
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| Apoptosis |
Programmed cell death or “cell suicide”. Apoptosis normally occurs as part of the body’s natural growth, maintenance and tissue renewal processes. Under certain circumstances, e.g. in the tissue surrounding a brain haemorrhage, this process can become uncontrolled and lead to widespread tissue cell death.
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| Conventional TACE | Transarterial chemoembolisation - a procedure whereby a chemotherapeutic agent is mixed into slurry and injected via a catheter, locally at a tumour site. |
| DC Bead | Biocompatibles' proprietary Drug-Eluting Bead product developed for loading with the chemotherapeutic agent by the hospital. This product received CE Mark regulatory approval in November 2003 for the treatment of malignant hypervascularised tumours. |
| Doxorubicin | A widely used chemotherapeutic agent for the treatment of a large number of cancers. It is a powerful cytotoxic drug that is not cell cycle specific. |
| Drug-Eluting Stent | A small metal scaffold coated with a drug which is placed in a blood vessel following angioplasty to keep the vessel open. |
| Endeavor® Drug-Eluting Stent |
The Endeavor stent, which received CE Mark in 2005 and is currently commercially available in more than 100 countries worldwide, is made of a cobalt alloy with a unique modular architecture designed to enhance deliverability. In addition to the potent cytostatic drug, zotarolimus, Endeavor is coated with phosphorylcholine (PC Coating), a biocompatible polymer designed to simulate the outside surface of a red blood cell and mimic the structure of the natural cell membrane, leading to an optimal healing response around the stent following implantation.
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| FDA | Food and Drug Administration of the United States. |
| GLP-1 |
Glucagon-Like Peptide-1, a small protein that is naturally produced in the human body and has been shown to have strong anti-apoptotic effects in preventing cell death.
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| Half-life |
The time required to eliminate half of a known quantity of a substance from the body.
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| HCC | Hepatocellular carcinoma, primary cancer of the liver. |
| IDE | Investigational Device Exemption - The approval by the FDA to carry out a clinical trial in the US with an unapproved device. |
| Irinotecan | A widely used chemotherapeutic agent for the treatment of colorectal cancer. It is a topoisomerase I inhibitor that interferes with DNA replication during cell division, leading to cell death. |
| Drug-Eluting Irinotecan Bead Clinical Trials | A family of clinical trials sponsored by Biocompatibles for the evaluation of Drug-Eluting Beads for the treatment of hepatic colorectal metastases. |
| Metastatic disease | The spread of a cancer from its original site (primary) to other locations within the body (secondary). In the case of colorectal cancer, the liver is the most common site of secondary tumours. |
| mCRC | Metastatic Colorectal Cancer is cancer of the colon or rectum that has spread, or metastasised to other parts of the body, such as the liver or lung. |
| PARAGON Bead™ | Biocompatibles' proprietary irinotecan HCl, drug-eluting bead. |
| PARAGON I | The first in a planned family of clinical trials sponsored by Biocompatibles for the evaluation of the Drug-Eluting Bead with irinotecan. PARAGON I is in hepatic colo-rectal metastases; Randomised controlled trial; Safety & Efficacy; 70 patients; multi-centre; United States; FDA approved; Recruitment expected to start around the middle of 2008. |
| Phosphorylcholine | A chemical group found in phospholipids in the membrane of cells. |
| PRECISION Bead | Biocompatibles' proprietary Drug-Eluting Bead product containing doxorubicin. |
| PRECISION Trials | A family of clinical trials for the evaluation of the Drug-Eluting Bead with doxorubicin. |
| PRECISION I | HCC; Safety, Efficacy & Dose Escalation; 28 patients; Barcelona; Recruitment complete |
| PRECISION II | HCC; Safety & Efficacy; 35 patients; Hong Kong; Recruitment complete |
| PRECISION III | Preliminary product evaluation of DC Bead; Recruitment complete |
| PRECISION IV | HCC; Randomised controlled trial; multi-centre; US; Not yet started |
| PRECISION V |
One of a family of clinical trials sponsored by Biocompatibles for the evaluation of the Drug-Eluting Bead with doxorubicin. PRECISION V is in HCC; Randomised controlled trial; Safety & Efficacy; 200 patients; multi-centre; Europe; Recruitment complete. Results to be announced September 2008.
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| PRECISION VI | Lung Cancer; Safety & Efficacy; 20 patients; Frankfurt; Recruitment in progress |
| PRECISION TACE | The use of either PRECISION Bead or DC Bead in the TACE procedure. PRECISION TACE results in a lower systemic drug exposure and more drug at the tumour site. |