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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| Arteriovenous malformation | A knot of distended blood vessels often overlying and compressing the surface of the brain. |
| Bead Block™ | This product has a CE Mark and 510k clearance from the FDA. Bead Block is intended for the embolisation of hypervascularised tumours and arteriovenous malformations. |
| Brachytherapy | The implantation of 'seeds' that deliver radiation for the treatment of prostate cancer. |
| CE Mark | A European standard for medical devices, a CE Mark indicates that a device meets the requirements of the Medical Device Directive and appropriate Quality System standards. |
| CellBeads™ | Stem Cells encapsulated in alginate microspheres, designed to deliver a therapeutic protein when implanted in a patient's body. CellMed's stem cells were derived from a single adult bone marrow donor and are stored and processed in a GMP-certified facility. |
| Chemoembolisation | Embolisation incorporating a chemotherapy drug. |
| CIRSE | The Cardiovascular and Interventional Radiological Society of Europe |
| CM1 | CellMed's proprietary form of GLP-1 that is an unmodified human sequence GLP-1 but is plasma stable. |
| Collagen | The principal protein in connective tissue, this fibrous, structural molecule provides strength and elasticity to tissue, skin, cartilage, ligaments, tendons and bones. It is used in cosmetic procedures as a dermal filler but normally requires a skin test prior to use in order to ensure the patient will not have an allergic response since most material is derived from animal sources. |
| Conventional TACE | Trans-Arterial Chemo-Embolisation - a procedure whereby a chemotherapeutic agent is mixed into slurry and injected via a catheter, locally at a tumour site. |
| Cosmetic Dermal Filler Bead | This product is an alginate bead for use as a dermal filler to address facial wrinkles. |
| DC Bead™ |
This product has a CE Mark. In Europe, DC Bead are intended to be loaded with doxorubicin for the purpose of:
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| DEBIRI | Treatment involving the Drug-Eluting Bead with Irinotecan |
| Dermal Filler Bead | This product is an alginate bead for use as a dermal filler to address facial wrinkles. |
| 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 Beads | Polymer embolisation microspheres designed to load and elute drugs. |
| 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. |
| Drug-Eluting Stent (DES) | A small metal scaffold coated with a drug which is placed in a blood vessel following angioplasty to keep the vessel open. |
| Embolisation | The introduction of material to reduce or completely obstruct bloodflow. |
| Endeavor® Stent |
Manufactured by Medtronic, the Endeavor® Drug-Eluting Stent is coated with phosphorylcholine (PC), sub-licensed from Biocompatibles, and Zotarolimus™, licensed from Abbott.
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| Endovascular delivery | Endovascular Delivery accesses treatment sites via major blood vessels. |
| FDA | The United States Food and Drug Administration, which regulates drugs and medical devices. |
| FOLFIRI | A chemotherapy regimen for the treatment of colorectal cancer, made up of the drug FOLinic Acid (Leucovorin), Fluorouracil (5-FU) and IRInotecan (Camptosar). |
| 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 tumour of the liver. |
| Hepatic colo-rectal metastases | Colo-rectal cancer that has spread to the liver. |
| Hyaluronic Acid | An important molecule in connective tissues, especially the skin, where it forms part of the extracellular matrix and helps to maintain dermal volume. It is now the most commonly used material in cosmetic applications as a dermal filler since it is less allergenic than collagen and provides a longer-lasting result. |
| Hypervascular tumour | A growth of tissue with an abnormally increased blood supply which may be malignant or benign. |
| IDE | Investigational Device Exemption - The approval by the FDA to carry out a clinical trial in the US with an unapproved device. |
| Interventional Oncology | Interventional oncology is thetreatmentn of cancer and cancer-related problems using minimally invasive, targetedtreatmentss performed under imaging guidance. |
| 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. |
| LC Bead™ | This product has 510k clearance from the FDA. LC Bead is intended for the embolisation of hypervascularised tumours and arteriovenous malformation. |
| 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. |
| Nexavar® (sorafenib) | Nexavar is an oral multikinase inhibitor for the treatment of two common types of cancer, hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC). |
| Non-vascular delivery | Non-vascular delivery access treatment sites by means other than endovascular delivery. These will include direct access in a surgical site and percutaneous, or through the skin, injection. |
| 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 Clinical Trials | A family of clinical trials for the evaluation of the Drug-Eluting Beads with doxorubicin. |
| 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. |
| Pre-loaded Bead | A Drug-Eluting Bead incorporating a drug which has been loaded into the Bead in Biocompatibles' facility. |
| Systemic chemotherapy | Treatment with anticancer drugs that travel through the bloodstream, reaching and affecting cells all over the body. |
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Tumour Response
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A measurement of the effect of a treatment on a tumour:
Complete Response - Disappearance of the targeted lesion
Partial Response - Greater than 30-50% (depending on evaluation method) reduction in the targeted lesion
Progressive Disease - Greater than 20-25% (depending on evaluation method) increase in the targeted lesion
Stable Disease - All other cases
Objective Response - Complete and Partial Response
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