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One important medicine in the fight against HIV AIDS is didanosine also known as ddI and sold under the name Videx by Bristol-Myers Squibb BMS , a drug included on the WHO Essential Medicines List. The drug was discovered by the US National Institutes of Health, and the US Government holds the rights to the original ddI invention see patent table ; [64]. At the time ddI was discovered, Thai law did not permit the patenting of pharmaceutical products, so even if the US government had wanted to obtain a patent in Thailand, it could not have done so. However, in September 1992, Thai law was changed so that pharmaceutical products could be patented. BMS licensed the rights to ddI from the US Government. Although BMS could no longer obtain patents for ddI itself, since the structure of ddI was publicly known by then, they could still apply at any time for patents for "derivative" inventions relating to ddI see section 2.2 ; . On July 7th 1992, BMS filed just such a patent application in Thailand, intended to protect a specific formulation of ddI[65]. In this patent application, the invention was limited to a specified range of about 5-100mg of ddI per dosage unit. During the examination of the patent application, the Thai Department of Intellectual Property DIP ; allowed BMS to remove the limitation in the dosage range. In many patent offices it is allowable to amend a patent application, but only so long as certain rules are followed. If the amendment was allowed without following these rules, for example by mistake, and a patent granted, then the patent may be invalid. On January 22nd 1998, the Thai Patent Office granted a patent for this unlimited invention. The effect of this unlimited patent was apparently to prevent the Thai Government Pharmaceutical Organisation GPO ; from manufacturing any sort of ddI tablet. After a campaign to try to persuade the government to issue a compulsory licence, it was decided to manufacture ddI in a powdered form instead. But the powdered form has an unpleasant taste and side effects that the tablet form does not have, and it is more difficult to take than a tablet. Accordingly, on May 9th 2001, a case was filed at the Thai Central Intellectual Property and International Trade Court CIPIT ; [66] by three plaintiffs the AIDS Access Foundation and two people living with HIV AIDS against two defendants, BMS and DIP ; . The plaintiffs demanded, among other things, that BMS amend their patent claim back to the limited dosage range originally asked for. The three CIPIT judges delivered a comprehensive judgement on October 1st 2002. The judgment clearly confirmed that these two individuals and the NGO had the right to challenge the BMS patent. The legal reasoning for this finding quotes the 2001 Doha Declaration on TRIPS and Public Health probably one of the first judgements to refer to the Doha Declaration directly. Since the TRIPS Agreement must be interpreted and implemented so as to promote and support access to medicines for the people as a whole and since those suffering from HIV AIDS can be injured by a patent blocking access to affordable medicines, the judgement says, they had the right to challenge the patent. The judgement also found that the amendment that BMS made and the Thai DIP allowed was unlawful. It confirmed that under Thai law the most important factor in determining the scope of patent protection is the wording of the patent claims. The scope of the allowable patent claims depends on the details of the invention described to the public in the patent document. One of the reasons that the amendment was unlawful was that the removal of the dosage limitation of about 5-100mg expanded the scope of protection beyond what was described in the patent document description. The judgement ordered BMS and DIP to amend the patent by putting back the limitation. This judgement was very important and it will give a lot of support to those fighting for access to essential medicines in Thailand and elsewhere in developing countries. At the time of writing the judgement was under appeal by BMS and DIP.
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SPECIAL ARTICLE Report of a workshop for clinical research: Care of human immunodeficiency virus-infected children in developing countries Philippe Lepage, M.D., PH.D., Rosemary Spira, M.D., Sam Kalibala, M.D., Kuben Pillay, M.D., Carlo Giaquinto, M.D., Katia Castetbon, M ., Connie Osborne, M.D, Christian Courpotin, M.D. and Franois Dabis, M.D., PH.D., for The International Working Group on Mother-to-child Transmission of Hiv ORIGINAL STUDIES Costs and benefits of respiratory syncytial virus immunoglobulin to prevent hospitalization for lower respiratory tract illness in very low birth weight infants T. Michael O'shea, M.D., M.P.H., Mary Ann Sevick, SC.D. and Laurence B. Givner, M.D. The incidence, presenting features, risk factors and significance of late onset septicemia in very low birth weight infants Avroy A. Fanaroff, M.B., B.CH., Sheldon B. Korones, M.D., Linda I. Wright, M.D., Joel Verter, PH.D., Ronald I. Poland, M.D., Charles R. Bauer, M.D., Jon E. Tyson, M.D., Joseph B. Philips III, M.D., William Edwards, M.D., Jerold F. Lucey, M.D., Charlotte S. Catz, M.D., Seetha Shankaran, M.D. and William OH, M.D., for the National Institute of Child Health and Human Development Neonatal Research Network Culture-positive tuberculosis in human immunodeficiency virus type 1-infected children H. Simon Schaaf, M.Med. PAED. ; , Agneta Geldenduys, M.B., CH.B., Robert P. Gie, M.Med. PAED. ; and Mark F. Cotton, F.C.P. Epidemiology of diarrheal disease among children enrolled in four west coast health maintenance organizations Umesh D. Parashar, M.B.B.S., M.P.H., Robert C. Holman, M.S., Joseph S. Bresee, M.D., Matthew J. Clarke, M.A., Philip H. Rhodes, PH.D., Robert L. Davis, M.D., Robert S. Thompson, M.D., John P. Mullooly, PH.D., Steven B. Black, M.D., Henry R. Shinefield, M.D., S. Michael Marcy, M.D., Connie M. Vadheim, PH.D., Joel I. Ward, M.D., Robert T. Chen, M.D., M.A., Roger I. Glass, M.D., PH.D. and the Vaccine Safety Datalink Team Astrovirus infection in association with acute, persistent and nosocomial diarrhea in Bangladesh Leanne E. Unicomb, B ., Nurun Nahar Banu, M ., Tasnim Azim, PH.D., Asma Islam, M.B.B.S., P. K. Bardhan, M.B.B.S., M.D., A. S. G. Faruque, M.B.B.S., M.P.H., Andrew Hall, PH.D., Christine L. Moe, PH.D., Jacqueline S. Noel, B ., Stephan S. Monroe, PH.D., M. John Albert, PH.D. and Roger I. Glass, M.D., PH.D. Impact of erythromycin on respiratory colonization of Ureaplasma urealyticum and the development of chronic lung disease in extremely low birth weight infants Ellen D. Bowman, M.D., B.S., F.R.A.C.P., Ananda Dharmalingam, M.B., B.CH., B.A.O., D.C.H., Wei-qui Fan, M.B., Fiona Brown, M.B., B.S. and Suzanne M. Garland, M.B., B.S., F.R.C.P.A., FAC.S.H.P. 581.
3 Department of Anesthesia and Intensive Care Medicine, University of Vienna Medical School, A-1090 Vienna, Austria. 4 Department of Vascular Surgery, University of Vienna Medical School, A-1090 Vienna, Austria and eszopiclone.
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Drug Name CEENU CAP 40MG Lomustine ; CEENU PAK DOSEPACK Lomustine ; cladribine inj 1 mg ml cyclophosphamide lyophilized for inj 1 gm cyclophosphamide lyophilized for inj 2 gm cyclophosphamide lyophilized for inj 500 mg cyclophosphamide tab 25 mg cyclophosphamide tab 50 mg CYTOXAN INJ 1GM Cyclophosphamide ; CYTOXAN INJ 200MG Cyclophosphamide ; CYTOXAN INJ 2GM Cyclophosphamide ; CYTOXAN INJ 500MG Cyclophosphamide ; CYTOXAN TAB 25MG Cyclophosphamide ; CYTOXAN TAB 50MG Cyclophosphamide ; ELIGARD INJ 22.5MG Leuprolide Acetate 3 Month ELIGARD INJ 30MG Leuprolide Acetate 4 Month ELIGARD INJ 7.5MG Leuprolide Acetate ; ELOXATIN INJ 100MG Oxaliplatin ; ELOXATIN INJ 50MG Oxaliplatin ; EMCYT CAP 140MG Estramustine Phosphate Sodium ; etoposide cap 50 mg etoposide inj 20 mg ml FARESTON TAB 60MG Toremifene Citrate ; FASLODEX INJ 125MG Fulvestrant ; FASLODEX INJ 250MG Fulvestrant ; FEMARA TAB 2.5MG Letrozole ; floxuridine for inj 0.5 gm flutamide cap 125 mg GLEEVEC TAB 100MG Imatinib Mesylate ; GLEEVEC TAB 400MG Imatinib Mesylate ; HEXALEN CAP 50MG Altretamine ; hydroxyurea cap 500 mg INTRON-A INJ 10MU Interferon Alfa-2B ; INTRON-A INJ 10MU PEN Interferon Alfa-2B ; INTRON-A INJ 10MU ML Interferon Alfa-2B ; INTRON-A INJ 18MU Interferon Alfa-2B ; INTRON-A INJ 25MU Interferon Alfa-2B ; INTRON-A INJ 3MU PEN Interferon Alfa-2B ; INTRON-A INJ 3MU 0.5 Interferon Alfa-2B ; INTRON-A INJ 50MU Interferon Alfa-2B ; INTRON-A INJ 5MU Interferon Alfa-2B ; INTRON-A INJ 5MU PEN Interferon Alfa-2B ; INTRON-A KIT 10MU ML Interferon Alfa-2B ; INTRON-A KIT 3MU 0.5 Interferon Alfa-2B ; LEUKERAN TAB 2MG Chlorambucil ; leuprolide acetate inj 5 mg ml leuprolide acetate inj kit 5 mg ml LUPR DEP-PED INJ 11.25MG Leuprolide Acetate ; LUPR DEP-PED INJ 15MG Leuprolide Acetate ; LUPR DEP-PED INJ 7.5MG Leuprolide Acetate and ethosuximide.
Estramustine [EM; estradiol-3-bis 2-chloroethyl ; carbamate] is an effective antineoplastic agent for treatment of prostatic tumors 1 ; . Chemically, EM consists of estradiol covalently linked to nitrogen mustard by a carbamate ester bond see Fig. 1 ; . The cytotoxicity of the compound apparently depends on the combined effects of the hydrophobic steroid and hydrophilic mustard moieties, since neither steroid nor nitrogen mustard produce similar pharmacologic effects themselves 2-5 ; . Initially, the specificity ofantitumor activity was shown to result from the presence of high concentrations of an EM-binding protein EMBP ; of 46 kDa in prostate tissue 6 ; . EMBP apparently modulates the accumulation of EM in prostate tumors, with resultant increased therapeutic efficacy. Nevertheless, the precise mechanism by which EM induces cytotoxicity remains unknown. More recent immunofluorescence studies have revealed that prostatic binding protein is present in numerous cytoplasmic vesicles in rat ventral prostate secretory cells 7 ; . Since it is thought that prostatic binding protein and EMBP may be the same or similar proteins 7 ; , one possibility is that EM accumulation in secretory vesicles is somehow toxic to the cell. However, the cellular targets of EM remain to be identified and there is no evidence that EM remains in vesicles after initial drug uptake. By using cytological methods, we have shown that EM has hitherto unexpected effects on cellular structure and integrity. In related studies, EM has been shown to disrupt microtubule complexes and their related function in cultured fish epithelial pigment cells, as well as in DU 145 tumor cells 8 ; . Here we report the use of a fluorescent drug probe to determine the sites of the incorporation and action of EM. Conjugation of EM and dansyl chloride DnsCl ; permitted visualization of drug uptake into live cells by phase-contrast and epifluorescence microscopy. The cytotoxicity of EM and.
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A new square wave pulse generator specifically designed for in ovo electroporation has been introduced by Intracel, specialist suppliers of products for electrophysiology and transgenesis. The TSS20 Ovodyne is an up-to-the-minute electronic design offering simplicity of operation and low cost. It is based on experience and customer feedback from Intracel's TSS10 pulse generator, a mainstay of this application for a number of years, despite having been designed as a more general purpose instrument. All the features normally required for in ovo electroporation are incorporated in the TSS20 Ovodyne, including multi-pulse programming, with adjustable voltage to a resolution of 0.1 v and adjustable space between pulses. Operating parameters, which are shown on the matrix display, also include resistance measurement and a re-settable pulse indicator that confirms the number of pulses delivered. Remote hand and foot switches are optional. For further information contact Tim Scot, Intracel Ltd, Tel. 01763 262680, Fax. 01763 262676, E-Mail. intracel intracel , intracel.
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In some patients with prostate cancer and who manifest disease progression during maximal androgen blockade MAB ; therapy, discontinuation of antiandrogen treatment might result in a significant fall in the level of serum prostate-specific antigen PSA ; , and this is often correlated with clinical improvement antiandrogen withdrawal syndrome ; . However, a decline in the PSA level after the withdrawal of estramustine phosphate is extremely rare. We report here on a case of dramatic decline in the PSA level after withdrawal of estramustine phosphate in a patient with hormone refractory prostate cancer. Korean J Urol 2007; 48: 751-753 ; Key Words: Prostate cancer, Estramustine, Chemotherapy and exemestane.
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PSA prostate-specific antigen; SWOG Southwest Oncology Group; D E docetaxel estramustine arm; M P mitoxantrone prednisone arm. Relative to baseline. Log ng mL per month.
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In view of the increased insight in the biology of cancer, and more specifically of prostate cancer, there are many options which can be considered in patients who develop HRPC. Potential approaches are secondary hormonal manipulations, immunotherapy, chemotherapy, inhibition of invasion and metastases, inhibition and or blockade of growth factor receptors or growth factor receptor pathways and inhibition of neo-angiogenesis. A few general comments should be made before discussing the results of chemotherapy and other approaches. The patient population enrolled in these studies can be very heterogeneous with respect to prior therapy and extent of disease. How many lines of hormonal therapy have been given? What was the extent of radiotherapy given? The latter is especially relevant in view of bone marrow reserve, quite often a relevant factor for adequate chemotherapy. Is it a PSA relapse or clinically symptomatic disease? Furthermore, when chemotherapy is given, is continuous hormonal treatment required? Sufficient information regarding the degree of androgen deprivation is not always given. What is the definition of hormone refractory disease? Androgen independent is not the same as hormonal independent. Patients who progress after androgen ablation may respond to ketoconazole [7], corticosteroids [8], aminoglutethimide [9], anti-androgens, such as flutamide [10], estrogens [11], estramustine phosphate [12] and progestational agents [13]. Furthermore, responses after withdrawal of antiandrogens in the presence of castrate levels of testosterone are well documented [14]. This type of information is quite often not given. Minimal requirements for entry into protocol or for changing therapy in a patient who becomes refractory to treatment include i ; castrate levels of serum testosterone and ii ; clinical or biochemical evidence of disease progression. In the case of anti-androgens, documentation of progression after withdrawal for a minimum of 46 weeks prior to the start of new therapies is required. Endpoints of clinical studies can be objective response with measurable disease, decline in PSA levels, quality of life, pain relief or change in analgesic use or both, time to progression, time to new therapies and, most important, overall survival. These heterogeneous endpoints make it difficult to discuss the results of various trials. Response in bone, the most frequent site of metastatic disease, is very difficult to measure. Therefore, the objective results observed in patients with soft tissue, measurable disease may not reflect the disease that is most generally seen in the population. Changes in PSA generally correlate with the activity of prostate cancer in all stages. Most patients with relapsing disease have elevated PSA levels [15]. Prostate-specific antigen rise as a surrogate endpoint for disease progression has been subject to misinterpretation, given the fact that PSA rise precedes radiographic and clinical progression by a matter of.
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Tables 6 and 7. Table 6 shows the uptake phase of.
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Prospective study of estramustine phosphate for hormone refractory prostate cancer patients following androgen deprivation therapy.
Personalized clinical trial searches are also performed on a patient's behalf by cancerconsultants reference: hussain m, smith d, el-rayes b, et al neoadjuvant docetaxel and estramustine chemotherapy in high-risk locally advanced prostate cancer.
4. Several recent studies demonstrated that oral estramustine and oral etoposide have activity in hormone refractory prostate cancer and they are tolerated well [59-61]. Is suramin effective in the treatment of advanced prostate cancer? In a multi-center, double-blinded, phase III study 458 patients with hormone-refractory prostate cancer who required narcotic analgesics for bone pain were randomized either to suramin and hydrocortisone or placebo and hydrocortisone [67]. Median follow-up was 21 months. Pain response and median duration of pain response were significantly superior in patients who were treated with suramin. Relative risk of progression was 1.0 in the suramin arm comparing to 1.5 in the placebo arm P - 0.0003 ; . Adverse events were comparable in both groups. Neuropathy, which was often reported in previous studies with suramin was seen 1% of the patients in this trial. Suramin may provide a significant palliative advantage and delay in disease progression in hormone-refractory prostate cancer. Conclusions After many years in which few advances in the treatment of prostate cancer could be observed, a number of new observations have been made in the last several years. - In clinically localized disease, although neoadjuvant hormonal therapy prior to radical prostatectomy decreases positive surgical margin rates, no improvement in survival or biochemical relapse rates have been shown. - In patients with locally advanced disease, androgen deprivation combined with radiation therapy may improve outcome. - There is suggestive evidence that three-dimensional conformal radiation therapy may improve cure rates for locally advanced prostate cancer. - Current data are not sufficient to show that interstitial low dose rate brachytherapy is comparable to more conventional treatments for localized prostate cancer. It may be of use in very selected patients with low-grade tumors and low PSA. - Immediate hormonal therapy for certain patients with advanced prostate cancer improves survival. - Whether or not maximum androgen blockade improves survival remains controversial. It may adversely affect quality of life in patients with metastatic prostate cancer. - Intermittent hormonal therapy may improve quality of life, although effect upon survival is unknown. - Chemotherapy in combination with androgen deprivation is currently being studied as front-line therapy in advanced prostate cancer. - Suramin may provide significant palliative advantage and delay in disease progression in hormone refractory prostate cancer. References and eszopiclone.
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