Vienna, August 31st, 2007

Dear doctors, dear colleagues,

thanks for your interest in Ukrain which we like to present you. Ukrain is the first anti-cancer drug without any side effects in therapeutical dosage and furthermore it has malignotoxic efficacy, that means Ukrain is selectively toxic against cancer cells but not against normal cells. This has been proven in various studies. Various researchers at different institutions in many countries performed in-vitro tests were on 16 cancer and 9 normal cell lines comparing the effects of Ukrain. They detected that at a dose range toxic to cancer cells Ukrain does not harm normal cells. This is probably the reason why intramuscular administration of Ukrain does not cause tissue necroses.

Following studies compared the effects of Ukrain on cancer and normal cells:
Hohenwarter et al, 1992: human osteosarcoma and melanoma cell lines; human endothelial cells from umbilical vein.
Cordes et al, 2002: human tumor cell lines MDA-MB-231 (breast), PA-TU-8902 (pancreas), CCL-221 (colorectal), U-138MG (glioblastoma); human skin and lung fibroblastic cells HSF1, HSF2 and CCD32-LU.
Roublevskaia et al, 2000: LNCaP prostate cancer cells.
Roublevskaia et al, 2000: ME180 and A431 carcinoma cell lines; HaCaT normal human keratinocytes.
Gagliano et al, 2006: glioblastoma MI cell lines T60, T63.
Habermehl et al, 2006: Jurkat A3 T-lymphoma, caspase-9 DN expressing Jurkat, caspase-8 and FADD negative Jurkat, CD95/TRAIL-resistant Jurkat A3, and Bcl-2 overexpressing Jurkat cells; Jurkat J16 control cells, cFLIP-L expressing Jurkat cells.
Panzer et al, 2000: HeLa human cervical carcinoma and Hs27 (human foreskin fibroblasts), WHCO5 (squamous oesophageal cancer); Graham 293 (transformed human embryonic kidney) and Vero (transformed African green monkey kidney).

As UKRAIN® accumulates in tumor or metastases areas quickly after injection and influences the immune system of different patients in different way; the dosage is not selected according to body weight or surface, but according to the tumor burden and immune status of the patient. A single dose is 5 to 20 mg per injection depending on tumor mass, growth rate, the extent of the disease and the immune status of the patient. The schedules we suggest in this letter are result of years of experience and represent the newest recommendations.

It is strongly recommended to start the treatment with UKRAIN in a hospital, at least 7-10 days on in-patient basis. This would allow careful monitoring of the patient. The occurrence of reactions on the treatment and possible side effects due to tumor degradation products would not be overseen. If tumor lysis syndrome occurs, it can be managed properly. Some patients have transient headache at the beginning of the treatment. This does not need the therapy to be stopped. In some cases this headache can be due to brain metastases.

The proposed general schedule is as follows:

After that surgical reduction of tumor burden should be considered. If surgery is planned, the therapy should be continued as in the first nine days. After surgery, the immune system of the patient can be suppressed. Small doses of Ukrain express immune modulating effect, so UKRAIN should be taken orally as soon as the general condition of the patient after surgery would allow it, at a dose of 1 ampoule (5 mg/5 ml) per day for three days.

If the tumor is relatively large (more than 4 cm in diameter), a surgical treatment is strongly recommended.

Following therapy can be performed on out-patient basis according to following schedule:

and so on, two times a week, 5 and 20 ml in turn, for eight weeks in total.

If the treatment is starting from very beginning on out-patient basis, following schedule should be used:

and so on, two times a week, 5 and 20 ml in turn, for eight weeks in total.

In the case of lung cancer or lung metastases, on the injection-free days Ukrain should be administered as inhalation.

Although most patients to be treated with Ukrain have already exhausted all conventional treatment modalities, the best results with Ukrain can be obtained if the therapy is started as soon as possible after diagnosis. Previous radiation courses or chemotherapy cycles can impair the immune functions of the patient and interfere with the effects of Ukrain.

The therapy with Ukrain has to be continued to full tumor remission. Sometimes six and more cycles are needed to achieve significant clinical benefit and not only to improve quality of life but to increase survival, also.

Best regards

Dr. Wassil Nowicky