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CANCER AUTOVACCINE (CAV)CANCER AUTOVACCINE (CAV) New specific active anticancer agent New specific active anticancer agent

From Science To Business 11-12 October 2006, Kyiv

G.P.PotebnyaG.P.Potebnya Telephone : Telephone : 259-91-94; 259-08-75259-91-94; 259-08-75

  E-mail : E-mail : nauka@onconet.kiev.uanauka@onconet.kiev.ua

R.E.Kavetsky Institute of Experimental Pathology, Oncology and R.E.Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology, NAS of Ukraine Radiobiology, NAS of Ukraine

Kyiv 03022, UkraineKyiv 03022, Ukraine

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Proprietary information statementProprietary 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.

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Problem Description & Market NeedProblem Description & Market Need

Cancer Diseases (on 100 000 populations): In the world:In the world: 210210 Central and East Europe:Central and East Europe: 349349 Ukraine:Ukraine: 341341((162000 in year 2005)162000 in year 2005)

Russia:Russia: 314314

CAV could be used for treatment 125000 of CAV could be used for treatment 125000 of all cases of cancers in Ukraine.all cases of cancers in Ukraine.

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Brief technology descriptionBrief technology description prof. D.G.Zatula

CAV prepared from autologous tumor CAV prepared from autologous tumor cells and products of synthesis of a cells and products of synthesis of a saprophytic microorganism B.subtilis B-saprophytic microorganism B.subtilis B-7025;7025;

CAV introduced by hypodermic CAV introduced by hypodermic injections. The complete course consists injections. The complete course consists of 3 injections with 7 day's interval. The of 3 injections with 7 day's interval. The revaccination will be carried out through revaccination will be carried out through 1 and 6 months;1 and 6 months;

CAV prevented relapses and metastasis CAV prevented relapses and metastasis after surgery treatment, after surgery treatment, increased increased overall and relapse-free survival of overall and relapse-free survival of patients;patients;

CAV is recommended as independent CAV is recommended as independent immunotherapeutic agent in the immunotherapeutic agent in the postoperative period.postoperative period.

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AdvantagesAdvantages

1.1. Wide specter cancer’s forms, where CAV treatment could be Wide specter cancer’s forms, where CAV treatment could be used.used.

2.2. CAV produced from own cells of patients, so there is no any CAV produced from own cells of patients, so there is no any risk of SPID, or other’s infection diseases and it’s need no risk of SPID, or other’s infection diseases and it’s need no control methods concerning alien infection agents.control methods concerning alien infection agents.

3.3. CAV is most effective at the late stages of cancer. CAV is most effective at the late stages of cancer. 4.4. Effectiveness of CAV treatment may be compared, or better, Effectiveness of CAV treatment may be compared, or better,

then chemo- or radiotherapy, but without so characteristic for then chemo- or radiotherapy, but without so characteristic for them toxic effects.them toxic effects.

5.5. Cost of production and treatment by CAV more lower then Cost of production and treatment by CAV more lower then chemo- or radiotherapy. chemo- or radiotherapy.

6.6. Combination to other methods of therapy: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 18-21 days after their end.

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EFFICACY ANTICANCER AUTOVACCINE DURING EFFICACY ANTICANCER AUTOVACCINE DURING COMPLEX THERAPY IN STOMACH CANCER COMPLEX THERAPY IN STOMACH CANCER

PATIENTSPATIENTS ( (Overall survival)Overall survival)

• CAV treatment CAV treatment enhanced 5-years enhanced 5-years survival (57% versus survival (57% versus 31%), 10-years 31%), 10-years survival (50% versus survival (50% versus 27%); 27%);

• CAV treatment of CAV treatment of stomach cancer stomach cancer patients has no patients has no analogous.analogous.

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Stomach cancer, stage ІІІ

Operation+Vaccine

Operation

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EFFICACY ANTICANCER AUTOVACCINE DURING EFFICACY ANTICANCER AUTOVACCINE DURING COMPLEX THERAPY IN LUNG CANCER PATIENTSCOMPLEX THERAPY IN LUNG CANCER PATIENTS

((Overall survival)Overall survival)

• CAV treatment CAV treatment enhanced 5-years enhanced 5-years survival (39% versus survival (39% versus 10%);10%);

• CAV treatment of lung CAV treatment of lung cancer patients has no cancer patients has no analogousanalogous

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3 5

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Lung cancer, stage ІІІА

Operation+Vaccine

Operation

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Stage of development (clinical tests if Stage of development (clinical tests if medical) and international patentsmedical) and international patents

CAV treatment were supported by National Academy CAV treatment were supported by National Academy of Science of Ukraine, Ministry of Health and of Science of Ukraine, Ministry of Health and Farmcommittee of UkraineFarmcommittee of Ukraine

It was obtained permission (certificate) for using CAV It was obtained permission (certificate) for using CAV in Ukraine’s clinicsin Ukraine’s clinics

Now 8 clinics in country successfully use this Now 8 clinics in country successfully use this treatmenttreatment

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Targeted Market SegmentTargeted Market Segment

• CAV could be used for treatment of most CAV could be used for treatment of most spread cancers formsspread cancers forms

Among them:

For menFor men:: For women: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%

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In comparison with existing products or methodsIn comparison with existing products or methodsSummary of 5-year' s survivals patients with rectum cancer

(III stage), who were undertaken different forms of treatments

Treated patientsTreated patients Overall Overall survivalsurvival

Relapse-free Relapse-free survivalsurvival

SurgerySurgery 29,0%29,0% 19,6%19,6%

Surgery+ radiotherapySurgery+ radiotherapy 42,7%42,7% 34,0%34,0%

Surgery Surgery +Chemotherapy+Chemotherapy

50,0%50,0% 30,0%30,0%

Surgery Surgery +Chemotherapy+CAV+Chemotherapy+CAV

77,0%77,0% 30,0%30,0%

Surgery +CAVSurgery +CAV 63,0%63,0% 38,0%38,0%

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Competitive MatrixCompetitive MatrixIn comparison with another autologous anticancer

vaccines (colon cancer –5 years survival)

Characteristics R.E.Kavetsky R.E.Kavetsky Institute National Institute National

Academy of Academy of Sciense, Kiev, Sciense, Kiev,

UkraineUkraine

Massachusetts Massachusetts General Hospital, General Hospital,

BostonBoston, USA, USA

Department of Department of Oncology, Oncology, University University

Hospital, Hospital, Antwerp, Antwerp, Belgium. Belgium.

Overall survival 78%78% 83% 78%

Cost 100 $ 100 $ 5000-30000 $ 5000-30000 $

Side effects 10-20%10-20% 30-40% 70-90%

Components of vaccine

Tumor antigens Tumor antigens +cytotoxic lectin +cytotoxic lectin B.subtilisB.subtilis

Living irradiated Living irradiated tumor cells+ tumor cells+ living BCGliving BCG

Living irradiated Living irradiated tumor cells+ tumor cells+ living BCGliving BCG

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OpportunitiesOpportunities

1. In common work to obtain licences for1. In common work to obtain licences for

CAV treatment in EC countries, USA and CAV treatment in EC countries, USA and RussiaRussia

2. In common work to produce and use2. In common work to produce and use

CAV in this countriesCAV in this countries

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Contact information

G.P.Potebnya

Telephone : 259-91-94; 259-08-75

 E-mail : nauka@onconet.kiev.ua

R.E.Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology, National Academy of Science, Ukraine