Haelan als alleenstaande behandeling en als aanvullend middel op chemokuren bij borstkankerpatienten verdubbelt effectiviteit met tegelijkertijd vermindering van 5x de dosis chemo, aldus een Duitse studie. FDA geeft daarom goedkeuring aan fase II trial

Maart 2006: Bron: HAELAN RESEARCH FOUNDATION

Haelan geeft als enige behandeling en als aanvulling op chemokuren bij borstkankerpatienten opmerkelijk positieve resultaten blijkt uit Duitse studie. De resultaten zijn zo opmerkelijk dat de FDA goedkeuring heeft verleend voor een fase II studie van Haelan bij borstkanker zowel als aanvulling op chemo en als monobehandeling. De effectiviteit van de chemo werd verdubbeld met een vijf ker zo lage dosis chemo door Haelan.

September 27, 2006

Research Summary:
The effects of Haelan 951 as monotherapy and as a combined treatment with Doxorubicin (Adriamycin) chemotherapy on invasive ductile carcinoma breast cancer cell line BT 474.

Background:
The study was performed at Gemeinschaftspraxis fur Laboratoriumsmedizin in Recklinghausen, Germany. Tests on the cancer cell killing effect of both Haelan 951 and Doxorubicin were studied in addition to gene expression. (See Attached Study for complete details)

1) GAPDH: Cancer Cell killing was measured by the GAPDH gene expression. Only live cells have GAPDH gene expression. The GAPDH chart in the study measures cancer cell kill and survival by the agent being tested.

Results: Cancer Cell Survival

Combined Treatment:

5 % Doxorubicin + 3% Haelan 9511 (Note: Low Dose Chemotherapy (1/2% by vol. plus 3% by vol. Haelan 951) produces the same cancer cell killing as 5 times greater Doxorubicin strength without the severe toxic side effects and adverse gene expressions caused by stronger doses of the chemotherapy.

2. Bcl2 Gene Expression: Bcl2 is an anti-apoptotic gene. Higher gene expression is not desireable because it increases the resistance for the cell to die normally by apoptosis (suicide is the normal cell death). Therefore, the lower the Bcl2 gene expression (down regulation) - the better the conditions are for cancer cells to die.

3.) Bax Gene Expression: Bax is an pro-apoptotic gene. Higher gene expression is desireable because it reduces the resistance for the cell to die normally by apoptosis (suicide is the normal cell death). Therefore, the higher the Bax gene expression (up regulation) - the better the conditions are for cancer cells to die. Combined Treatment: 5 % Doxorubicin + 3% Haelan 951 (Note: Low Dose Chemotherapy (1/2% by vol. plus 3% by vol. Haelan 951) produces the same cancer cell killing as 5 times greater Doxorubicin strength and increases the Bax gene expression, which is desireable.).

4.) Topoisomerase IIa : Studies have shown that Topoisomerase IIa gene expression levels are increased in breast cancer non-responders to chemotherapy treatments. Likewise, breast cancer treated responders to chemotherapy show decreased gene expression levels of topoisomerase II. Higher gene expression (up regulation) is not desireable because it increases the resistance for the cell to die normally by apoptosis (suicide is the normal cell death). Therefore, the lower the topoisomerase IIa gene expression (down regulation) the better the conditions are for successful cancer treatment survival

Combined Treatment:
5 % Doxorubicin + 3% Haelan 951 (Note: Low Dose Chemotherapy (1/2% by vol. plus 3% by vol. Haelan 951) produces the same cancer cell killing as 5 times greater Doxorubicin strength and it gives a lower Topo IIa gene expression, which is desireable.)

5) MDR1 : The MDR1 gene acts as an efflux pump and gives a cell multi-drug resistance by enhancing the transport of toxic cancer killing compounds out of the cell. Increasing chemotherapy concentrations raises the expression of MDR1. Higher MDR1 gene expression levels raise drug resistance and decrease the effectiveness of chemotherapy drugs on cancer cells. Higher gene expression (up regulation) of MDR1 is not desireable because it lowers chemotherapy concentrations in the cell resulting in increased cancer cell survival. Therefore, a lower MDR1 gene expression (down regulation ) produces greater cancer cell kill rates and lower multi-drug resistance to chemotherapeutic agents. Combined Treatment:
5 % Doxorubicin + 3% Haelan 951 (Note: Low Dose Chemotherapy (1/2% by vol. plus 3% by vol. Haelan 951) produces the same cancer cell killing as 5 times greater Doxorubicin strength and it gives a lower MDR1 gene expression, which is desireable.)

In summary, an evaluation of the cytoxic effects of Haelan 951 shows dose dependent cancer cell kill as well as desireable gene expression when compared to Doxorubicin (Adriamycin) chemotherapy treatment at toxic levels. The toxic level increases with higher concentrations of Doxorubicin and adverse gene expression is experienced resulting in multi-drug resistance and resistance to apoptosis by the cancer cells being targeted by the treatment. The addition of Haelan 951 to a low dose Doxirubicin (Adriamycin) chemotherapy treatment of .5 % (½ %) produced the same cancer cell kill as monotherapy treatment with 2.5% Doxorubicin (5 times stronger) and in addition produced favorable gene expressions involved with these breast tumors.

A review of the attached study and the pathology showing anti-angiogenesis gives strong indications that the combination of Haelan 951 and Doxorubicin (Adriamycin) offers a better treatment option than Doxorubicin as a monotherapy. Estrogen metabolism and other mechanisms of action also favor the addition of Haelan 951 to the treatment of breast cancers with Doxorubicin by itself.

HAELAN RESEARCH FOUNDATION