Estudios Clínicos

1.1.- Tolerability of two twice-repeated dose levels of FR-91 by intramuscular injection in healthy volunteers.

Result: The results of the present study that FR-91 at the dose of 1 y 3 units, intramuscularly injected twice at a week interval, is well tolerated. No reaction of intolerance was observed. Most of the adverse reactions considered as related to the product were local reactions expected for such a kind of product. Besides, the treatment has shown to be devoid of immune-allergic activity.
Signed by: Calderon.P, Lins.R, Deroubaix.X, Stockis.A.
Investigation centre: Bio-Pharma, Wavre, Belgium.
Date: November, 1994

To see them http://www.geamed.com/archivos/1.1.ENGLISH.CLINICAL.FR-91.RENOVEN.BIO-BAC.pdf

2.1.- IMMUNOLOGIC

2.1.1.- Analyses and clinical data of ten patients. Pathology treated: Hepatitis B.

Result: The efficiency was evaluated according to the improvement of clinical symptoms and related to the decrease of transaminase and bilirrubina, as well as the appearance of serum anti-HBsAg in the analyses carried out alter treatment. All patients showed a positive evolution in clinic symptoms. The serum levels were normal in all patients with Hepatitis B (seven cases) as well as one patient with relapse episode, probably due to the evolution to chronic (three cases).In these patients It should be pointed out that HBsAg is not detectable two months after starting the treatment with anti-HBsAg showing a positive evolution to normality and disappearance of tendency to chronic patient. In these 7 patients with acute disease, anti-HBsAg also appeared and HBsAg was no detectable.
Signed by: De La Fuente L, Bermejo MJ.
Investigation centre: Centro Médico Inmunológico Dr. Castelo, Madrid, Spain.
Date: February, 1995

To see them http://www.geamed.com/archivos/2.1.1.ENGLISH.CLINICAL.FR-91.RENOVEN.BIO-BAC.pdf

2.1.2.- Analyses and clinical data of patients with Acquired immunodeficiency syndrome (AIDS).

Result: All patients shown positive evolution in CD4 cell counts, and even those patients with classification of A, B or C sub 3 (CD4 <200 cells/mm3), showed CD4 cell number after treatment superior to 200 cells /mm3
A similar evolution was observed for CD8 cell number in all patients and the coefficient of inversion of Cd4/Cd8 improved positively, with a reduction in the inversion range. The clinical parameters, as well as the HIV related diseases, showed a favourable evolution in all patients, with all of them responding perfectly to the concomitant treatments, administered at the same time as FR-91. In same cases, The HIV-related pathology persisted after treatment but it was due to pathology nature (i.e tuberculosis) And the necessary treatment period with the concomitant drugs, superior at the evaluation time for this study.
Signed by: De La Fuente L, Bermejo MJ.
Investigation centre: Centro Médico Inmunológico Dr. Castelo, Madrid, Spain.
Date: February, 1995

To see them http://www.geamed.com/archivos/2.1.2.ENGLISH.CLINICAL.FR-91.RENOVEN.BIO-BAC.pdf

2.2.- OSTEOARTICULAR

2.2.1.- Comparative phase II clinical trial on the efficacy and tolerability of three dose levels of FR-91 (0.5, 1 and 2 units) versus placebo in the treatment of hip or knee osteo-arthritis during eight weeks.

Result: The global tolerability was judged from good to excellent in the majority of patients treated with FR-91. However, there were after 8 weeks of treatment, 3 cases of poor tolerability and other 4 with moderate intolerance while all patients of placebo group, except one showed an excellent tolerability. The global tolerability was dose-dependent. The results suggest a beneficial potential of FR-91 with reference to paracetamol intake, which can work as a confusion factor in this study.
Signed by: P.Calderón, D.Rosillón A. Stockis y G. Verbruggen.
Investigation centre: Bio-Pharma, Wavre, Belgium.
Date: July, 1996

To see them http://www.geamed.com/archivos/2.2.1.ENGLISH.CLINICAL.FR-91.RENOVEN.BIO-BAC.pdf

2.3.- ONCOLOGIC

2.3.1.- Analyses and clinical data of patients with Metastatic focus from mamma carcinoma.

Result: The answer to the treatment with FR-91 is completely efficient by radiological demonstration, gamma graphical, RMM, TAC, etc in 85% of the patients compiled in this report, although on the rest 15% did not have confirmatory data of laboratory or radiological test. With respect to hematologic analysis of those patients, and with regard to the treatment, a slight increase of total white cells was observed (100% of patients). When the results about lymphocytes are evaluated using absolute values, a slight increment is observed. From the analysis we can conclude that FR-91 can be a useful product in the Management of metastatic disease from breast carcinoma.
Signed by: De La Fuente L, Bermejo MJ.
Investigation centre: Centro Médico Inmunológico Dr. Castelo, Madrid, Spain.
Date: August, 1995

To see them http://www.geamed.com/archivos/2.3.1.ENGLISH.CLINICAL.FR-91.RENOVEN.BIO-BAC.pdf

3.1.- IMMUNOLOGIC

3.1.1.- Testing the effects and tolerability of FR-91 in the treatment of  Positive HIV patients.

Result: Based on these results, it can be concluded that the most beneficial dose was 2 units; this treatment with 2 units of FR-91 administered by intramuscular route, every 48 hours for 12 weeks, increased significantly the CD4 and CD8 lymphocytes counts. The beneficial effects seem to be dose-dependent.
Signed by: E. Jägel-Guedes, J. Schietz.
Investigation centre: Meddoc ApS Denmark.
Date: July-September, 1997

Full study not available.

3.2.- OSTEOARTCULAR

3.2.1.- Comparative phase III clinical trial on the efficacy and tolerability of one dose level of FR-91 versus placebo in the treatment of hip or knee osteo-arthritis for twelve weeks.

Result: The result of the present study carried out in 301 patients allow to support a statistical evidence of a beneficial effect of FR-91, in comparison with the placebo group, in three month treatment of osteoarthritis. However, the beneficial potential of Fr-91 could be greater and be partially hidden by consumption of paracetamol which seems to act as a negative factor on the evaluation of efficacy. The improvement of algo-functional indexes and the reduction of the pain due to the treatment with Fr-91 are statistically very significant. Local reactions were common and related to injected dose of FR-91. Systematic events -headache, fever- occasionally occurred and were of weak intensity.
Signed by: Dr Guram Tsagareishvili, Dr. Javakhadze.
Investigation centre: Medinserv State Company, Tbilisi, Georgia.
Date: September, 1996

To see them http://www.geamed.com/archivos/3.2.1.ENGLISH.CLINICAL.FR-91.RENOVEN.BIO-BAC.pdf