5 December 2011
In 1976 I applied for the registration of Ukrain as an anti-cancer drug. Proceedings were pending at the Federal Ministry of Social Security and the Generations under GZ 921.726/1-81.
With my letter of 27 July 1981 to the Federal Minister of Health, Dr. Kurt Steyrer, (www.ukrin.com/docs/1981-07-27-brief-zulassung-1981.pdf) I sent a reminder about the status of the case and asked the minister to accelerate the registration proceedings for humanitarian reasons. I included the necessary documentation and pointed out that all conditions for registration were fulfilled as provided for by the Spezialitätenordnung (Medical Specialities Order) 1947 (www.ukrin.com/docs/1947-spezialitaetenordnung.pdf):
a) The preparation is produced from two known substances which had already been registered in Austria and used in medical practice. Both Thiotepa as well as greater celandine alkaloids had already been in the Pharmacopea Austriaca and the German pharmacopeia for a long time (www.ukrin.com/docs/USP_XXII.pdf, www.ukrin.com/docs/Chel_majus.pdf). Numerous studies have demonstrated that no free Thiotepa is present in the final product (www.ukrin.com/docs/gutmann-1996.pdf).
b) In addition, with this letter I submitted to the minister study data from the National Cancer Institute (USA) and the Institut de Cancerologie et d`Immunogenetique (France), which clearly show that the preparation is effective against cancer cells while at the same time being less toxic than its starting substances (www.ukrin.com/docs/untersuchungen-invitro.pdf).
c) As proof of its therapeutic efficacy in the treatment of cancer patients I submitted 60 medical histories of patients who had exhausted all other forms of therapy, 33 of whom responded well to therapy (www.ukrin.com/docs/Manfreda_1980.pdf).
In the letter from the Minister of Health, Dr. Kurt Steyrer, of 14 August 1981 it was pointed out that only the submission of a license was necessary for registration to be granted. I made the appropriate application immediately in 1981. I finally received the license in 1988 and promptly submitted it to the ministry (www.ukrin.com/docs/Konzessionsdekret.pdf). All preconditions for registration were thereby fulfilled.
There was no single reason to delay registration of my anti-cancer drug which thousands of cancer patients were waiting for. Registration of Ukrain should thereby have been granted without delay.
Instead of granting registration the authorities demanded clinical studies whose study protocols first had to be approved by the Pharmaceutical Advisory Board (Arzneimittelbeirat). I drew up the study protocols and submitted them to the Pharmaceutical Advisory Board.
The Pharmaceutical Advisory Board of the Ministry of Health approved the following studies on 23 June 1993 (www.ukrin.com/docs/Arrouas_1993.pdf):
1. “Open, controlled colorectal cancer study”
Such a study was submitted to the Ministry of Health.
The results of the study were published in an article by Prof. Dr. Susak Y.M. “Comparison of Chemotherapy and X-Ray Therapy with Ukrain Monotherapy for Colorectal Cancer”: “The survival rate (up to 21 months) of patients with non-metastising colorectal cancer in the group treated with Ukrain was 78.6% and in the control group it was 33.3%” (www.ukrin.com/docs/Susak_1996.pdf). 96 patients took part in the study, 48 in the Ukrain group and 48 in the chemotherapy + radiation group.
The publication by Prof. Dr. Bondar “Comparative Evaluation of the Complex Treatment of Rectal Cancer Patients (Chemotherapy and X-Ray Therapy, Ukrain Monotherapy)”, which was also submitted to the ministry, states: “Prolongation morbi were found to have developed 14 months later in six patients in Group 1 (25.0%), whereas in Group 2 they were found only in two cases (8.3%)”(www.ukrin.com/docs/Bondar_1998.pdf).
(“14 months later progression of the disease was found in 6 patients (25%) from Group 1 and only 2 patients (8.3%) from Group 2.”)
Of 24 patients from the Ukrain-treated group 18 are still alive today (75%), more than 12 years later (www.ukrin.com/docs/dubai2010.pdf).
2. Clinical study of malignant melanoma (this study was only carried out as a historical comparison because all previous controlled studies of malignant melanoma had only shown a success rate of 10-20%. However, it is known that this disease can react sensitively to immunomodulating agents. Several doctors have treated malignant melanoma very successfully with Ukrain resulting in long lasting remissions. I enclose an example from Prof. Dr. P. Wodnianski)…” (The results of the melanoma study are enclosed, www.ukrin.com/docs/nci-1.pdf, www.ukrin.com/docs/wodniansky.pdf, www.ukrin.com/docs/stabuc_1996.pdf, www.ukrin.com/docs/hamler_1996_1.pdf, www.ukrin.com/docs/Danilos_1992.pdf, www.ukrin.com/docs/zemskov_1996_2.pdf).
In tests at the National Cancer Institute (Bethesda, Maryland, USA) the melanoma cell line was highly sensitive to Ukrain (www.ukrin.com/docs/untersuchungen-invitro.pdf). In an experimental study on mice Ukrain inhibited the growth and metastasis of the B-16 malignant melanoma. The therapeutic use of Ukrain for malignant melanomas has brought about full remissions in some patients.
3. “Clinical test outside hospitals in accordance with § 42 AMG (Pharmaceuticals Act). With this type of clinical test various oncological diseases that appear in the normal practice of town and country doctors were to be treated with Ukrain. The analytical work in the design of this study is adapted to the normal possibilities of a general practitioner and certain limitations of countryside areas, particularly as many of these cases involved people who had been previously treated and whose disease was progressing.” (www.ukrin.com/docs/erfahrungsberichte.pdf).
On the basis of §12 and §42 AMG, which were in force on 23 June 1993, many doctors used Ukrain and their reports were submitted to the Ministry of Health with the request for rapid registration (www.ukrin.com/docs/erfahrungsberichte.pdf).
Approximately 35,900 new cancer cases are registered in Austria each year and 19,900 people die of cancer (http://globocan.iarc.fr/factsheets/populations/factsheet.asp?uno=40#KEY).
In spite of this Ukrain is still not registered in Austria.
Of the 269 specialist publications dedicated to the preparation Ukrain 174 can be accessed via PubMed (http://www.ncbi.nlm.nih.gov/pubmed/).
Ukrain is the first and only anti-cancer preparation which kills only cancer cells while leaving healthy cells undamaged (www.ukrin.com/docs/selektivewirkung.pdf). On account of its selective effect it has been nominated twice for the Nobel Prize and once for the Alternative Nobel Prize.
If Ukrain research had been rewarded with the Nobel Prize (www.ukrin.com/de/nobel-preis), the situation now would of course have been totally different. This would have made everyone in the world aware that it is finally possible to kill cancer cells without damaging healthy cells. The development of Ukrain has shown new paths in cancer research. New medicaments with a selective effect will doubtlessly be developed on this basis. The diagnosis of cancer will thereby lose its terror.
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