AlloStim^® is a living cell therapy designed to elicit the Mirror Effect. AlloStim^® incorporates a variety of immunomodulatory and immunostimulatory properties. These properties are incorporated into specially designed protocols in order to elicit the ‘Mirror’ of the immune effects that occur after allogeneic stem cell transplant procedures. The immune mechanisms that occur in these transplant procedures result in powerful tumor debulking responses against chemotherapy-resistant tumors. This tumor debulking response can result in long-term durable remissions due to the special immune property of memory. Once the immune system is programmed to eliminate a cancer, this memory feature will cause the immune system to destroy tumors and then remember the tumor in order to prevent the tumors from recurring after treatment.

AlloStim^® is thoroughly tested to assure that the product that is delivered to patients at the time of administration, and in the 24h after administration, meets pre-determined identity and functional requirements.

The following are the pre-determined identity and functional specifications of AlloStim^®:

AlloStim^® Identity

AlloStim™ cells have unique properties. They combine the properties of memory Th1 helper cells, which are known to promote anti-tumor cellular immunity, with the properties of cytolytic T lymphocytes (CTL) and natural killer (NK) cells, which can directly kill tumors. AlloStim^® cells are activated allogeneic Th1 memory T-cells containing cytolytic granules.

Technical Specifications

T-Stim^® intermediary cells have the following identity phenotype: CD4+, CD45ROlo, CD62Lhi, CD40Llo, CD25+, IFN-gamma+, IL-4-,

AlloStim^® cells have the following identity phenotype: CD4+, CD45ROhi, CD62Llo, CD40Lhi , CD25+, IFN-gamma+, IL-4-, granzyme+ and perforin+.

AlloStim^® Function

Functional requirements of AlloStim^® are based upon the amount of interferon-gamma (>1500pg/10⁶ cells/4h) and IL-4 (< 50pg/10⁶ cells/4h) produced and the degree of change in lowering CD62L and increasing CD40L.

The expression of interferon-gamma and surface CD40L are essential to AlloStim^® function.

AlloStim^® Dose Forms

AlloStim^® is available in the following dosage forms:

• 1 ml formulation buffer containing 1 x 10⁷ cells with 1 x 10⁷ beads attached in a 3 ml syringe for intradermal injections (ID),
• 3 ml formulation buffer containing 3 x 10⁷ cells with 3 x 10⁷ beads attached in a 10 ml syringe for intratumoral or intralesional injection (IT),
• 5 ml of formulation buffer containing 5 x 10⁷ cells attached to 5 x 10⁷ beads a 10 ml syringe for intravenous infusion (IV).