Pangaea Clinic of Naturopathic Medicine

THE EFFECT OF UKRAIN ON CANCER

UKRAIN is produced from alkaloids from the plant Chelidonium majus L. (greater celandine) and the pharmaceutical Thiotepa. Both of these ingredients are approved as drugs and are in wide clinical use. However UKRAIN is much less toxic than its ingredients, while at the same time having a more powerful anti-carcinogenic effect. Gas chromatography has shown that there is no free (i.e. unbound) Thiotepa in the final product UKRAIN.

UKRAIN:

is toxic against cancer cells at the therapeutic dose but not against healthy cells

accumulates at the site of the tumour very rapidly after injection

brings about the encapsulation of larger tumours through anti-angiogenesis (the inhibition of new blood vessels at the tumour site), thereby increasing operability

regenerates the immune system

Here are some of the specific findings of studies of UKRAIN made to date:

90 patients with histologically verified inoperable pancreatic cancer were treated in a controlled, randomised study at the University of Ulm (Germany). Patients in Group A received the chemotherapeutic drug Gemcitabine 1000 mg/m2, those in Group B received 20 mg UKRAIN, and those in Group C received 1000 mg/m2 Gemcitabine followed by 20 mg UKRAIN per week. Survival rates after 6 months were 26% in Group A, 65% in Group B and 74% in Group C. The results showed that in inoperable advanced pancreatic cancer, survival rates were doubled using UKRAIN in combination with Gemcitabine.

Patients were further observed after the conclusion of the study and it was noted that UKRAIN was well tolerated and could be administered without problem to all patients. UKRAIN brought about a significant increase in survival time in comparison to therapy with Gemcitabine alone. Combination therapy with Gemcitabine and UKRAINE showed no advantage over monotherapy with UKRAIN. As a consequence of the results of this study the doctors from the University of Ulm recommend UKRAIN monotherapy in the palliative treatment of advanced pancreatic cancer.

42 patients with pathologically verified pancreatic cancer were treated in a randomised study carried out by Prof. Zemskov (National Medical University Kiev, Ukraine). One group received vitamin C plus UKRAIN, the remainder (the control group) vitamin C plus a normal saline solution. The UKRAIN therapy dose was 10 mg intravenously every second day, to a total of 100 mg per patient. The survival rate after one year was 76% in the group treated with UKRAIN as opposed to 9.5% in the control group. The survival rate after two years was 48% in the UKRAIN-treated group and 5% in the control group.

96 patients with colorectal carcinomas were included in a randomised study conducted by Dr. Susak (National Medical University Kiev, Ukraine). 48 patients were treated with UKRAIN (15 of them with metastasising and 33 with non-metastasising colorectal tumours) and 48 patients were treated with the chemotherapeutic drug 5-FU and radiotherapy. The survival rate after 21 months was 75% in the group treated with UKRAIN and 33% in the group treated with 5-FU and radiotherapy.

48 patients with rectal carcinomas participated in a randomised study carried out by Dr. Bondar (Regional Cancer Centre, Donetsk). 24 patients received high-dosage radiotherapy and a therapy series with 5-FU before the operation, and another 24 patients received one series of UKRAIN therapy before the operation (10 mg every second day, to a total of 60 mg) and one series after the operation (to a total of 40 mg). During the following 14 months, 25% of patients who had received 5-FU and radiotherapy had relapses but only 8.3% of patients who had received UKRAIN. In the two years after this, 33.3% of patients who had received 5-FU and radiotherapy had relapses but only 16.7% of the patients who had been treated with UKRAIN.

75 patients with breast cancer (clinical studies I, II, III, T1-3NO-2MO, ages up to 70 years) were the subject of a controlled clinical study conducted at the University Grodno (Grodno, Belarus). They were divided into three groups, with 25 patients in each. Those in the first group received UKRAIN prior to their operation in the dosage of 5 mg every second day, to a total dosage of 50 mg, while those in the second group similarly received 10 mg of UKRAIN every second day to a total dosage of 100 mg. Those in the third (control) group were not treated with UKRAIN before their operation.

After treatment with UKRAIN, hardening of the tumor, a slight increase in the tumor size (5-10%) and proliferation of connective tissues were observed. The ratio of T4/T8 lymphocytes increased by 30%. Eight to 10 weeks after surgery, levels of ESR (a blood test to monitor inflammation in the body, which routinely increases after an operation) were found to be little more than half as high in the groups that had received UKRAIN, compared with the control group. This indicated faster post-operational healing and improvement in general condition of patients from the groups receiving UKRAIN.

The patients who were treated with a higher dosage of UKRAIN reported slight pain in the cancer area, and a slight increase in fever. However, faster tumour remission was observed in these patients.

The tumours appeared harder and slightly enlarged after UKRAIN therapy, and were easier to detect by ultrasound or radiological examination. Metastatic lymph nodes were also hardened and sclerotic (fibrous). Through this hardening process under the influence of UKRAIN, tumours and metastatic lymph nodes were clearly demarcated from healthy tissue and therefore easier to remove.

Complications such as prolonged lymphorrhoea (leakage of lymph onto the skin surface), skin necrosis (death of skin tissue), suppuration of the wound, and pneumonia, all occurred in patients from the two UKRAIN groups at only half the rate that they appeared in patients from the control group.

Based on the results of this study the scientists from Grodno recommended the use of UKRAIN, at the higher dosage, in all breast cancer operations.

28 patients with carcinoma of the bladder were divided into three groups for a prospective controlled clinical trial using either one, two or three cycles of UKRAIN therapy, with a two-week interval between cycles. Each cycle consisted of 10 mg/day intravenously, over 10 days. Tumors were assessed by cytoscopy and ultrasound before and two weeks after the end of treatment. The results were evaluated according to common response criteria. Response to therapy (either complete remission or partial remission) was observed in 4 from 9 patients receiving one cycle of UKRAIN, in 5 from 10 receiving two, and in 8 from 9 receiving three cycles. In no case was any growth of the tumour observed. Cases of complete remission were proportional to the number of cycles and total dose of UKRAIN. The three patients with complete remission had no relapse during 5-6 months of follow-up. No adverse events were reported. The authors concluded that better results are obtained with longer treatment.

74 patients with prostatic carcinoma were involved in a controlled study at the Villa Medica Clinic (Edenkoben, Germany). These patients had already been treated according to all conventional therapy protocols, and due to relapse and/or progression of the disease had no further conventional options available. They were treated with UKRAIN, and partially at the same time with local hyperthermia, and the following results were obtained: complete remission in 73% of patients and partial remission in 22%, with only 5% of patients showing no effect on the progress of the disease.

363 cancer patients with 47 different types of tumour were treated with UKRAIN between September 1997 and January 2003 at the Villa Medica Clinic (Edenkoben, Germany) under the medical direction of Dr. Aschhoff. These patients had already exhausted conventional means of therapy without success, and because of relapse and/or continued progression of the disease, UKRAIN therapy was undertaken. The following rates of full remission were achieved: breast cancer 31%, colorectal cancer 16.7%, bronchial adenocarcinoma 7.7%, small-cell bronchial carcimoma 21%, astrozytoma (brain tumor) 66.6%, neuroblastoma 60%, seminoma (testicular cancer) 75%, bladder carcinoma 50% (181, 189).

70 patients in the advanced stages of cancer participated in another study with the aim of finding the best clinical dose for UKRAIN. Again, these patients had already been treated according to all conventional methods, and due to relapse and/or advance of the disease no further therapy modalities were available to them, all therapeutic possibilities having been tried and failed. UKRAIN was administered by intramuscular or intravenous injection at doses of 2.5, 5, 10, 15, 20 or 25 mg increasing (2.5 to 25 mg per injection), decreasing (25 to 2.5 mg per injection) or stable (5, 10, 15, 20 or 25 mg per injection). Therapy lasted between 10 and 90 days. The intervals between series of injection were between 7 days and three months.

UKRAIN was generally well tolerated. Some patients experienced a pain-killing effect, and doses of morphine could be reduced or discontinued. In some patients subjective and objective symptoms appeared such as headache, dizziness, thirst, perspiration, increased urination, increased temperature (approx. 1 to 2 °C above normal) and pains in the tumour and metastases sites. These symptoms were observed in patients receiving different doses of UKRAIN. Some patients commented on feelings of warmth and heat, especially in the tumour area, with influenza-like symptoms. A temporary swelling of the tumour, increased pulse rate and a small decrease in blood pressure were also observed in some cases. These symptoms disappeared without any special additional treatment. In some cases with there was rapid sequestration (the detachment of dead from living tissue) of large tumours. The general condition of the patients, their appetite and their quality of life improved in most cases. In some cases tumour regression was observed as encapsulation, which made a surgical operation possible. In other cases, where the tumour was not too large, complete regression was achieved.

Depending on the general condition of the patient and the extent of the tumour, the best dosage of UKRAIN proved to be a stable one of 5, 10, 15 or 20 mg per injection daily or every second or third day. The toxins which are created by the regression of larger tumours can cause a poisoning of the whole body and worsen the general condition; this limits the application of UKRAIN at higher doses. In small doses, it was found that UKRAIN brings about improvement in the immune system. Higher doses bring about tumour regression.

The powerful anti-cancer properties of the drug have also been shown in numerous examples of patients treated outside the hospital environment, including cases of remission brought about by UKRAIN that have lasted 19 years after therapy. At the same time, randomised clinical studies confirm that these therapeutic successes were no coincidence but due to the anti-tumour effects of UKRAIN.

Regarding its principal modes of action, it has been shown in the case of pancreatic cancer cells that UKRAIN: halts the cell cycle in the prophase through inhibition of tubulin-polymerisation (an important step in cell division); reduces the increase in cell numbers; and brings about apoptosis (programmed cell death).

In vitro studies at the National Cancer Institute (Bethesda, Maryland, USA) showed that UKRAIN (NSC 631570) is malignotoxic (toxic for cancer cells) against all the solid cancer cell lines tested. This proved to be true for melanomas, for brain, ovarian, kidney and small cell and non-small cell lung carcinomas, and also for intestinal cancer cell lines for which no other medicament has shown a malignotoxic effect.

Doctor Chan's note: in-vitro studies often find that certain substances are toxic against cancer cell lines, but the better tests are from patient examples and patient trials.

To date UKRAIN has been tested on more than 100 cancer cell lines and has proved its malignotoxic effect against all of them, including pancreatic cancer cell lines and cell lines which were resistant to the chemotherapy drug Cisplatin, as well human tumour transplants. At the doses at which UKRAIN kills cancer cell lines, healthy cells are not attacked. The concentration of UKRAIN at which it would be toxic for normal cells is 100 times higher than the concentration which kills all cancer cell lines.

Some studies have shown that the anti-tumour effect of macrophages (important immune system cells) is increased by UKRAIN. These experiments were carried out both in vitro and in vivo, using various doses and methods of application (intravenous, intraperitoneal and subcutaneous). Intravenous injection proved itself to be the best method of application, and the best dose at which most tumour remissions were achieved with mice was 4 µg. This corresponds to a dose for humans of 7 to 10 mg at 70 kg body weight.

In a trial for potential side effects, 19 healthy volunteers were given UKRAIN by means of intramuscular or intravenous injection at doses from 5 to 50 mg every second or third day for up to 40 days. UKRAIN was well tolerated in all cases. A few volunteers reported local pain with a burning feeling during intramuscular injection. The pain disappeared very quickly after about two minutes. Some volunteers also reported feeling dizzy. At the beginning of UKRAIN therapy some of the volunteers felt a little tired. Some had increased body temperature, increased thirst and increased desire to urinate. However, there were no significant changes in the clinical picture. All haematological, chemical and urine levels showed only minimal fluctuations and remained within normal levels. For two volunteers who suffered from dyspepsia, spasmic and cholagogic (bile inducing) effects were reported. During the course of the study these symptoms also disappeared. It is also noteworthy that during the period of the study there were many cases of colds and influenza in the area where the study was carried out, but none of the volunteers receiving UKRAIN contracted such an illness. A tendency towards an increase in the CD4/CD8 cell ratio (an important sign of the normalisation of the immune system) was observed. After receiving UKRAIN all volunteers were in a good or even better state of health than before the study.

The results of this study showed therefore no sign that UKRAIN causes any kind of damaging side effect.

Dosage of cytostatics (drugs that halt tumour growth) is usually calculated according to the body surface or the weight of the patient. This is because conventional cytostatic drugs show no selective accumulation in tumour tissue, attacking fast-growing healthy tissue at the same time. The consequences of this are bone marrow suppression, hair loss and other typical side effects of chemotherapy. Because UKRAIN has an affinity to tumour tissue, the size of the dose depends rather on the total volume of the primary tumour and metastases. The most common dose is between 5 and 40 mg. At lower doses of UKRAIN it has been observed that some metastases disappear but others are unchanged. On the other hand, a high dose can lead to a rapid regression of the tumour, and the products which are thereby created can overtax the whole body. It is therefore sensible to select medium doses. The opinion has been expressed that smaller doses of UKRAIN could be given daily or every second day, and higher doses every third, fourth or fifth day or even only once a week. This was reported by the above-mentioned study at the University of Ulm.

After one month of UKRAIN therapy the tumour has typically begun to encapsulate, and operative removal or reduction of the tumour volume can then be considered. Tumour encapsulation caused by the anti-angiogenetic properties of UKRAIN has been confirmed by in vitro studies (136).

Finally, it is notable that normal cytostatics, as well as having numerous undesirable side effects, have a therapeutic index ranging from 1.2 to 1.8 (the therapeutic index being the difference between the effective and the toxic doses). That is, with normal cytostatics there is only a very small margin between the therapeutic and toxic doses. In contrast, the therapeutic index of UKRAIN is 1,250, so there is therefore no danger of an overdose.