A phase I trial assessing the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of single-dose Auron Misheil therapy in healthy male subjects.

BACKGROUND AND OBJECTIVE: Auron Misheil therapy (AMT) is a combination of widely used pharmaceuticals and herbal components that has been used since the 1980s as a supportive therapy, mainly in end-stage cancer patients on a compassionate basis. This phase I study was conducted to assess the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) properties of AMT in a controlled trial environment. METHODS: The study was conducted in a single rising dose, double-blind, placebo-controlled design. Three groups of eight healthy male volunteers received one of three doses of AMT (0·011, 0·033 or 0·066 mL AMT/kg body weight intramuscularly; n = 6 per group) or placebo (n = 2 per group). RESULTS AND DISCUSSION: Auron Misheil therapy was shown to be well tolerated, revealing no severe or serious adverse events. There were no unexpected PK or PD results for any of the three components of AMT. CONCLUSIONS: These data provide important PK, PD and safety data for AMT, and support further controlled clinical investigation in patients with different types of cancer as an option for supportive care.

Multiplex RT-PCR, a novel technique for the simultaneous detection of the DNA and RNA viruses causing rice tungro disease.

Rice tungro, economically the most important viral disease of rice, is a complex disease caused by two morphologically and genomically dissimilar viruses, Rice tungro bacilliform virus (RTBV), a double stranded DNA virus replicating through RNA intermediate and Rice tungro spherical virus (RTSV), a single stranded RNA virus with 3' poly (A) tail. A novel multiplex RT-PCR technique for the simultaneous detection of RTBV and RTSV from the total RNA extracted from tungro-infected plants has been developed. It involves a one-step reaction initiating first strand cDNA synthesis by oligo (dT) primer with poly (A) tailed RTBV transcript and RTSV genomic RNA as template for the PCR amplification. The results indicate that adaptation of this technique will strengthen the screening for tungro resistance among rice varieties and hybrids.

Risperidone in Indian patients with schizophrenia.

Conventional antipsychotic agents are not effective against negative symptoms of schizophrenia and are also noted for their extrapyramidal side effects. Risperidone is a noval antipsychotic agent whose dual antagonism of dopamine and serotonin receptors is believed to underlie its efficacy against negative symptoms and the low incidence of extrapyramidal side effects. An open, non-comparative study of seven weeks duration was performed to evaluate risperidone in the treatment of schizophrenia in Indian patients. Previous antipsychotic therapy was discontinued for a week before risperidone therapy was initiated. At the end of six weeks of risperidone therapy, clinical improvement (≥ 20% reduction in total score on positive and negative syndrome scale for schizophrenia (PANSS;; was shown by 128 (87.7%) of the 146 evaluable patients. Statistically significant reduction (p < 0.05) occurred in the total score of this scale and in the subscale scores for positive, negative and general psychopathology symptoms and in the clinical global impression severity score. The number of patients with adverse experiences were 108 (65.5%) at baseline and 120 (72.7%) at the end of risperidone therapy. Extrapyramidal symptoms, seen in 65 (39.4%) patients compared to 22 (13.3%) patients at baseline, were largely mild to moderate in intensity.

Detection of rice tungro bacilliform virus in field and glasshouse samples from India using the polymerase chain reaction.

Rice tungro bacilliform virus (RTBV) together with rice tungro spherical virus (RTSV) is the causal agent for the rice tungro disease. A rapid technique was developed to detect RTBV DNA in the crude extract of freshly collected leaf samples by polymerase chain reaction (PCR). This technique can detect the viral DNA in 1000-fold diluted leaf extract. Detection has been possible in samples stored upto 5 days after the collection. This technique may have wide application for the field diagnosis of RTBV infection.