1 CANCER AUTOVACCINE (CAV) New specific active anticancer agent From Science To Business October 2006, KyivG.P.Potebnya Telephone : ; R.E.Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology, NAS of Ukraine R.E.Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology, NAS of Ukraine Kyiv 03022, Ukraine Kyiv 03022, Ukraine

2 Proprietary information statement The technology material presented in this talk is available for licensing or joint product development. None of the slides contain any confidential or proprietary information.

3 Problem Description & Market Need Cancer Diseases (on populations): In the world: 210 In the world: 210 Central and East Europe: 349 Central and East Europe: 349 Ukraine: 341( in year 2005) Ukraine: 341( in year 2005) Russia: 314 Russia: 314 CAV could be used for treatment of all cases of cancers in Ukraine.

4 Brief technology description Brief technology description prof. D.G.Zatula CAV prepared from autologous tumor cells and products of synthesis of a saprophytic microorganism B.subtilis B- 7025; CAV prepared from autologous tumor cells and products of synthesis of a saprophytic microorganism B.subtilis B- 7025; CAV introduced by hypodermic injections. The complete course consists of 3 injections with 7 day's interval. The revaccination will be carried out through 1 and 6 months; CAV introduced by hypodermic injections. The complete course consists of 3 injections with 7 day's interval. The revaccination will be carried out through 1 and 6 months; CAV prevented relapses and metastasis after surgery treatment, increased overall and relapse-free survival of patients; CAV prevented relapses and metastasis after surgery treatment, increased overall and relapse-free survival of patients; CAV is recommended as independent immunotherapeutic agent in the postoperative period. CAV is recommended as independent immunotherapeutic agent in the postoperative period.

5 Advantages 1.Wide specter cancers forms, where CAV treatment could be used. 2.CAV produced from own cells of patients, so there is no any risk of SPID, or others infection diseases and its need no control methods concerning alien infection agents. 3.CAV is most effective at the late stages of cancer. 4.Effectiveness of CAV treatment may be compared, or better, then chemo- or radiotherapy, but without so characteristic for them toxic effects. 5.Cost of production and treatment by CAV more lower then chemo- or radiotherapy. 6.Combination to other methods of therapy: After radical operation (early stages of disease, the absence of metastasis) an effective utilization CAV without chemo- or radiotherapy. If it is necessary carryings out courses of chemo- or the radiotherapies immunotherapy by CAV may be started in days after their end.

6 EFFICACY ANTICANCER AUTOVACCINE DURING COMPLEX THERAPY IN STOMACH CANCER PATIENTS (Overall survival) CAV treatment enhanced 5-years survival (57% versus 31%), 10-years survival (50% versus 27%);CAV treatment enhanced 5-years survival (57% versus 31%), 10-years survival (50% versus 27%); CAV treatment of stomach cancer patients has no analogous.CAV treatment of stomach cancer patients has no analogous.

7 EFFICACY ANTICANCER AUTOVACCINE DURING COMPLEX THERAPY IN LUNG CANCER PATIENTS (Overall survival) CAV treatment enhanced 5-years survival (39% versus 10%);CAV treatment enhanced 5-years survival (39% versus 10%); CAV treatment of lung cancer patients has no analogousCAV treatment of lung cancer patients has no analogous

8 Stage of development (clinical tests if medical) and international patents CAV treatment were supported by National Academy of Science of Ukraine, Ministry of Health and Farmcommittee of Ukraine CAV treatment were supported by National Academy of Science of Ukraine, Ministry of Health and Farmcommittee of Ukraine It was obtained permission (certificate) for using CAV in Ukraines clinics It was obtained permission (certificate) for using CAV in Ukraines clinics Now 8 clinics in country successfully use this treatment Now 8 clinics in country successfully use this treatment

9 Targeted Market Segment CAV could be used for treatment of most spread cancers formsCAV could be used for treatment of most spread cancers forms Among them: For men:For women: For men: For women: Lung cancer - 21% Breast cancer - 21% Stomach cancer- 10% Cervical cancer - 6% Rectum cancer- 6% Rectum cancer- 5% Colon cancer- 5% Colon cancer - 6%

10 In comparison with existing products or methods In comparison with existing products or methods Summary of 5-year' s survivals patients with rectum cancer (III stage), who were undertaken different forms of treatments Treated patients Overall survival Relapse-free survival Surgery Surgery 29,0% 29,0% 19,6% 19,6% Surgery+ radiotherapy 42,7% 42,7% 34,0% 34,0% Surgery +Chemotherapy Surgery +Chemotherapy 50,0% 50,0% 30,0% 30,0% Surgery +Chemotherapy+CAV Surgery +Chemotherapy+CAV 77,0% 77,0% 30,0% 30,0% Surgery +CAV 63,0% 63,0% 38,0% 38,0%

11 Competitive Matrix Competitive Matrix In comparison with another autologous anticancer vaccines (colon cancer –5 years survival) Characteristics R.E.Kavetsky Institute National Academy of Sciense, Kiev, Ukraine Massachusetts General Hospital, Boston, USA Department of Oncology, University Hospital, Antwerp, Belgium. Overall survival78%83%78% Cost 100 $ $ Side effects 10-20% 10-20% 30-40% 70-90% Components of vaccine Tumor antigens +cytotoxic lectin B.subtilis Living irradiated tumor cells+ living BCG

12 Opportunities 1. In common work to obtain licences for CAV treatment in EC countries, USA and Russia CAV treatment in EC countries, USA and Russia 2. In common work to produce and use 2. In common work to produce and use CAV in this countries CAV in this countries

13 Contact information G.P.Potebnya Telephone : ; R.E.Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology, National Academy of Science, Ukraine