Clinical Investigations on Ukrain

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Ukrain against Pancreatic Cancer

Gemcitabine and Ukrain against Pancreas Cancer 2007
30 patients with pancreatic cancer received chemotherapy with Gemcitabine, combined with Ukrain after their cancer operations. Mild side effects were observed in 53%, no severe side effects occurred. In 80% of the patients recurrence of the disease was observed. The survival rates were 86.7% after one year, 76.6% after two years, 46.7% after three years and 23.3% after five years, which is much better than any previosuly known treatment results. The median survival time was 33.8 months.

Gemcitabine Versus Ukrain versus Ukrain/Gemcitabine 2002
90 patients with non-operapable pancreatic cancer were randomized into three different treatment arms. Patients in arm A received Gemcitabine, those in arm B received Ukrain, and those in arm C received gemcitabine and Ukrain.
In all three arms therapy was well tolerated and toxicity was moderate. Median survival was in arm A 5.2 months, in arm B 7.9 months, and in arm C 10.4 months. Actuarial survival rates after 6 months were 26%, 65% and 74% in arms A B and C, respectively.

Ukrain against Pancreatic Cancer 2002
21 patients were treated with 10 mg ukrain every second day x10. The control group received supportive treatment only. Ukrain treatment was well tolerated. Mean values on pain measure and
[url]=http://en.wikipedia.org/wiki/Performance_status]Karnofsky index[/url] were significantly better in the ukrain group than in controls (P<0.05). One-year survival was 76% in the ukrain group, compared to 9.5% in the control group.
Median survival after treatment with ukrain was 574 days, compared to 197 days in the control group.

Ukrain against Pancreatic Cancer 2000
42 patients with advanced symptomatic pancreas cancer were randomly assigned to receive either vitamin C and Ukrain , or vitamin C and normal saline . The one-year survival was 81% in the Ukrain group compared with 14% in the control group. The 2-year survival was 43% in the Ukrain group compared with 5% in the control group. Median survival was 17.17 months for Ukrain-treated patients and 6.97 months for the control group.

Breast Cancer
Ukrain against Breast Cancer 2000
75 patients with histologically confirmed breast cancer were divided into three groups of 25. The control group received symptomatic corrective therapy prior to their breast operation. The two other groups were given neoadjuvant therapy with Ukrain injections. The first group received a total course dose of 50 mg and the second group received a total Ukrain dose of 100 mg. Five to seven days after the last injection patients from all groups were subjected to operation. Practically all patients who were administered Ukrain noticed remarkable positive changes in the second half of treatment: improvement in appetite, normalization of sleep, disappearance of general weakness and the appearance of confidence in recovery. After the course of treatment with Ukrain, the contours of the tumorous node became more clearly defined, which facilitated operation. Changes in the tumor tissue were one-sided in their qualitative differences in comparison to the control group and were not dose-dependent. The results of this study showed the efficiency of both doses (50 and 100 mg) of Ukrain with the higher dosage performing slightly better.

Bladder Cancer
Mechanism in Bladder Cancer 2000
Ukrain prevents active free amino acid transport into urinary bladder tumor tissue, inhibiting the activities of protein biosynthesis, gluconeogenesis and energy production. The combined decrease in Glutamine and Leucine levels in urinary bladder tumor tissue is a specific sign of the antitumor effect of Ukrain and a mechanism of its cancerostatic action by controlling the processes of amino acid pool formation in the tumor.

Ukrain in Bladder Cancer 1998
28 patients with relatively small bladder cancer tumors were divided in three groups. The first group was treated with a total dose of 100 mg Ukrain, the second group received 200 mg Ukrain, and the third group was treated with 300 mg Ukrain. In all patients Ukrain was administered i.v. at a dose of 10 mg per day. Ukrain, at a total dose from 100-300 mg as neoadjuvant therapy in patients with T1N0M0 bladder cancer, resulted in either complete or partial regression of tumors in 60.7 +/- 9.2% of cases. The best treatment regime included three courses of Ukrain at 2-week intervals.

Prostate Cancer
Prostate Cancer 2000
15 patients with newly diagnosed prostate cancer received Ukrain at a total dose of 100 mg After two to three injections of Ukrain, all the patients noted considerable subjective improvements in their state. Ukrain increased the amount of total T-lymphocytes, including "active" T-lymphocytes, decreased the content of T-suppressors and increased that of T helpers, correspondingly raising the T helper/T-suppressor ratio.

Colorectal Cancer
Rectal Cancer 1998
48 patients suffering from rectum cancer were included in a randomized study were 24 patients received an intensive course of X-ray therapy together with chemotherapy with 5-fluorouracil before operation. The 24 patients in group II were treated with Ukrain as monotherapy, 10 mg each second day before operation and a total of 40 mg after surgical intervention. Repeated Ukrain courses were also given 6 months after surgical operation. Recurrence were found to have developed 14 months later in six patients in group I 25.0%, 8.3% in group II.

Colorectal Cancer 1996
96 patients with colorectal carcinomas were included in a randomised study. 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 78% in the group treated with UKRAIN and 33% in the group treated with 5-FU and radiotherapy.

Lung Cancer
Lung Cancer 1992
Lymphocyte subsets were evaluated in nine men (aged 42-68 years, mean 57 years) with histologically proven lung cancer, previously untreated. Ukrain was applied as an intravenous injection every three days. One course consisted of 10 applications of 10 mg each. The results showed a restoration of cellular immunity that was accompanied by an improvement in the clinical course of the disease. This effect was particularly pronounced in patients who responded to
further chemotherapy. Objective tumour regression (CR+PR) was seen in 44.4% of
treated patients. Four out of nine patients (44.4%) died of progressive disease
during the course of this study.

Cervix Cancer
Cervix Cancer 1992
Nine women with a stage IB voluminous uterine cervical cancer received Ukrain before and after operation. Three out of nine eligible cases had partial responses after operation, while six cases remained stable. There were signs of activation of the immune defence. Two patients were treated with adjuvant radiotherapy due to lymphatic involvement and all nine patients were still alive at least six months after follow-up.

Meta-analysis
Ernst ans Schmid 2005
Ernst et al. searched for all relevant randomised clinical trials Ukrain .
Seven trials met the inclusion criterias. Without exception, their findings suggest that Ukrain has curative effects on a range of cancers. However, the methodological quality of most studies was considered poor. In addition, the interpretation of several trials was impeded by other problems. The data from randomised clinical trials suggest Ukrain to have potential as an anticancer drug. However, they meant that numerous caveats prevented a positive conclusion, and that independent rigorous studies are urgently needed

Case Reports
Kidney Cancer with Liver metastasis from 2000
A 52-year-old man with renal cell carcinoma was treated with surgery and chemotherapy (vinblastine). Ukrain was administered after tumor progression to the vena cava inferior and appearance of liver metastasis. The drug induced a complete remission, which has lasted 32 months since the first therapy course.

Synovial Sarcoma from 2000
A 23-year-old woman, diagnosed with a synovial sarcoma of the peritoneum, underwent an operation for tumor extraction, and got Ukrain afterwards. Nearly 4 years after Ukrain therapy, the patient is in complete remission.

Breast Cancer from 2000
A 50-year-old female patient with breast cancer (stage IV) was treated with Ukrain because of the impossibility of radiotherapy and chemotherapy. Ukrain facilitated the surgeon in performing an operation to remove the primary tumor as well as the metastatic lymph nodes. After the second and third courses of Ukrain, the patient demonstrated clinical remission.

Case Series from 2000
A total of 203 advanced-stage cancer patients suffering from different types of cancer who had exhausted all conventional forms of therapy were treated with the Ukrain. Forty-one patients (20.2%) achieved total remission, 122 (60.1%) partial remission and only 40 (19.7%) did not respond to treatment.

Treatment of Kaposis Sarcoma and AIDS from 1996
Two case reports are presented of therapy with Ukrain for the treatment of AIDS patients with Kaposi's sarcoma. During treatment the Kaposi's sarcoma lesions diminished in size, showed decolouration and no lesion appeared in the 30-day interval after the beginning of treatment. Both patients tolerated Ukrain well and showed an improved immunohaematological status: an increase in total leukocytes, T-lymphocytes and T-suppressor numbers. In one case T-helper lymphocytes were also increased.

Treatment of Astrocytoma from 1996
Ukrain, a semisynthetic thiophosphoric acid compound of alkaloid chelidonine from Chelidonium majus L. (1) causes regression of various tumours. Among other effects, its action seems to depend on the stimulation of the immune system which very often is deficient in cancer patients. Its use in a patient with subtotal extirpation of a frontal anaplastic grade III astrocytoma seems to have reduced growth speed significantly

Urethral Carcinoma from 1996
In a patient with low grade differentiated urethral carcinoma (histologically: urothelial carcinoma G2 and G3, pT1 with low grade differentiation) operation was carried out, with recurrence after two months. Instead of reoperation the patient was given Ukrain as monotherapy. No carcinoma was detected four months later by histological examination or during examinations three years later.

Oesophageal carcinoma from 1996
A poorly differentiated squamous cell oesophageal carcinoma was diagnosed in a patient after an 11 month history of difficulty in swallowing. The condition was inoperable according to clinical and X-ray contrast examinations. Radiation therapy with three courses of chemotherapy was carried out, but no amelioration was obtained. Ukrain therapy (course of 46 ampoules) was undertaken; this changed the situation entirely: all the subjective problems disappeared and no residual cancer was seen on the X-rays. Complete remission is seen nearly four years after Ukrain therapy.

Ovary cancer from 1996
A patient with adenocarcinoma in the right ovary with lymphangitis carcinomatosa, staged as G II-G III pT3, pNX, pMX, was treated after palliative surgery by chemotherapy and, simultaneously, with Ukrain. Two and a half years after treatment the patient is without any signs of tumour recurrence.

Cervix cancer from 1996
A grade IV cervical cancer was treated with endocervical cone biopsy (electrocoagulation) in a 28 year-old lady. Three years later examination revealed cervical carcinoma in situ and a conization was recommended, which the patient refused. She was treated with Ukrain instead. The grading regressed steadily and after one year of Ukrain therapy all stagings were normal. Three years after the start of Ukrain therapy she gave birth to a healthy child. Eight years later she has no recurrence and is healthy.

Breast Cancer from 1996
A patient with breast cancer who was not previously given any therapy before receiving Ukrain had a full clinical remission with 12 years without any oncopathological symptoms.

Breast Cancer with lung metastasis from 1996
A recurrent breast cancer with lung metastases was treated with the new anticancer drug Ukrain. Lymph nodes and lung metastases disappeared. The patient showed a full clinical remission.

Rhabdomyosarcoma from 1996
A six year old child was diagnosed to have a rhabdomyosarcoma of the muscles of the right buttock. Because of impossibility of radiotherapy and chemotherapy, treatment with Ukrain 10 mg i.v. once every two days, 10 injections (100 mg) was instituted. The following clinical effects were recorded: reduced pain in joints, improved appetite and condition, increased physical activity, reduced fever.

Malignant Melanoma from 1996
A patient with a metastasizing malignant melanoma (stage III) was treated with Ukrain monotherapy. Before and during the first Ukrain course of treatment the patient excreted melanin in the urine. After the third course melanin was no more detectable and the patient has been without any symptoms of disease for the last 12 years.
A female patient was treated for a metastatic malignant melanoma. She was treated chemotherapeutically, with interferon, and surgically. After recurrence two years later the chemotherapy regime was changed and Ukrain therapy was administered between the chemotherapy series. The patients multiple metastases in the lungs and a complete remission which lasted at least more than one year was achieved.

Case Series from 1992 with sedative and anti-allergic effects
Preliminary clinical observations and studies on immunological
response-indicators were made in eight patients with malignant tumours, who had been administered parenteral injections of Ukrain. The results suggest that the preparation is a non-toxic immunostimulator inducing production of thymodependent
T lymphocytes. The preparation improves general health of patients, has anti-allergic action, and sedative and anti-inflammatory effects. It can inhibit growth of malignant tumours.

Case Series from 1992, II
Thirty six stage III cancer patients were treated with Ukrain injected intravenously every second day in a dose of 10 mg per
injection. Each patient received 300 mg of the drug (30 injections). The results obtained indicate that Ukrain, in a concentration not cytostatic in normal cells, is cytostatic for malignant ones, and may suppress
the growth of cancer. The compound also has immunoregulatory properties,
regulating the T lymphocyte subsets

Case Reports from 1992
More than 400 documented patients with various cancer types have been treated with Ukrain.The authors report on a 9 year old girl with "untreatable" Ewing Sarcoma, a 58 year old woman with colon cancer with lymph node metastasis and a 69 year women with breast cancer with skeleton metastasis. All were treated with Ukrain with complete remission lasting at least several years as a result.
Case Reports from 1991
Twenty-seven patients with various malignancies were treated with
Ukrain.The study showed an activation of the immune defence in the treated patients as well as a favourable course of their disease and in general well-being.

Other Publications
Debate in the Lancet about how to set up a phase II study 2000-2001
Two english researchers proposed to set up a phase II study on 8 different cancer types with 15 patients in each group testing the effect of ukrain. They claim that the manufacturer of Ukrain, Nowicky pharma refused to participate in this project unless the made a dose finding study on pancreatic cancer instead. One of the issues would be who would fund an independent investigation comittee. The english researchers suspect accuse Nowicky pharma of being afraid performing an objective evaluartion. In the end both sides publicly agreed that tehy want to perform the investifation, but we are still waiting for it the investigation to happen....

Treatment of Hepatitis C
Ukrain can be used in the treatment of Chronic hepatitis C, alone or in combination with Interferon, preparations; in the cases with Hepatit C Virus genotype 1b, Ukrain seems more promising than IFN. Individual therapy with Ukrain and IFN increased the efficacy of treatment 2.5-fold in comparison with standard monotherapy with the same preparations, significantly decreased the number of side effects and dramatically improved cost-effectiveness.

Ukrain in healthy volunteers 1992
Phase I of a clinical study of Ukrain was performed in 19 healthy outpatient volunteers. During the intramuscular injections the volunteers felt only localized pain; some reported drowsiness, increased thirst and polyurea. There was a slight, insignificant increase in body temperature and negligible decrease of blood pressure in some cases. In conclusion, it can be said that Ukrain is well tolerated in healthy volunteers in the doses of 5, 10, 20, and 50 mg/injection, even during prolonged (up to three years) administration.

Phase II trial from 1992
70 patients, ranging in age from 14 to 80 years, were given Ukrain to determine the appropriate dose range for
and the clarification of dose/response relationships, in order to provide
an optimal background for wider therapeutic trials. The patients were treated with different dosages and with different dosage intervals. All patients were at terminal stages of their disease.

Therapeutic intervention: 
Therapeutic Substance(s):