NEWS HIGHLIGHTS
Published Studies Related to Alferon N Injection (Interferon Alfa-N3)
Recombinant interferon-alpha2b improves immune response to hepatitis B vaccination in haemodialysis patients: results of a randomised clinical trial. [2009.09.18]
The use of adjuvants capable of improving the deficient immune response to hepatitis B virus (HBV) vaccine in haemodialysis patients is highly needed. Among potential adjuvants, type I interferons deserve a special attention in view of their known effects promoting cellular and humoral immune responses...
Analysis of PTEN and HIF-1alpha and correlation with efficacy in patients with advanced renal cell carcinoma treated with temsirolimus versus interferon-alpha. [2009.08.15]
BACKGROUND: Exploratory subgroup analyses from the phase 3 global advanced renal cell carcinoma (ARCC) trial were conducted to determine if baseline levels of the tumor molecular markers PTEN and HIF1 alpha correlated with efficacy in patients treated with temsirolimus (Torisel) versus interferon-alpha (IFN)... CONCLUSIONS: The baseline status of the molecular markers PTEN and HIF1 alpha did not correlate with efficacy in renal cell carcinoma patients treated with temsirolimus versus IFN. Patients demonstrated OS and progression-free survival benefit when treated with temsirolimus regardless of PTEN and HIF1 alpha status. Thus, baseline PTEN and HIF-1 levels may not predict response to temsirolimus. Alternatively, the lack of correlation may be due to the variability in tumor specimens that occurred because of the global nature of the clinical trial. Other markers in the phosphoinositide 3-kinase (PI3K)/Akt pathway may be of utility as predictors of response to temsirolimus in patients with advanced renal cell carcinoma.
Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. [2009.08.06]
BACKGROUND: Treatment guidelines recommend the use of peginterferon alfa-2b or peginterferon alfa-2a in combination with ribavirin for chronic hepatitis C virus (HCV) infection. However, these regimens have not been adequately compared... CONCLUSIONS: In patients infected with HCV genotype 1, the rates of sustained virologic response and tolerability did not differ significantly between the two available peginterferon-ribavirin regimens or between the two doses of peginterferon alfa-2b. (ClinicalTrials.gov number, NCT00081770.) 2009 Massachusetts Medical Society
Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. [2009.08.01]
PURPOSE: A randomized, phase III trial demonstrated superiority of sunitinib over interferon alfa (IFN-alpha) in progression-free survival (primary end point) as first-line treatment for metastatic renal cell carcinoma (RCC). Final survival analyses and updated results are reported... CONCLUSION: Sunitinib demonstrates longer overall survival compared with IFN-alpha plus improvement in response and progression-free survival in the first-line treatment of patients with metastatic RCC. The overall survival highlights an improved prognosis in patients with RCC in the era of targeted therapy.
Efficacy of consensus interferon in treatment of HbeAg-positive chronic hepatitis B: a multicentre, randomized controlled trial. [2009.07.09]
BACKGROUND: Consensus interferon (CIFN) is a newly developed type I interferon. AIMS: This multicentre, controlled trial was conducted to determine the efficacy of CIFN and to compare it with alpha-1b-interferon (IFN-alpha1b) in the treatment of patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B... CONCLUSION: These findings suggest that 9 microg CIFN is effective in the treatment of patients with HBeAg-positive chronic hepatitis B. It can gradually induce ALT normalization and HBV DNA clearance and HBeAg loss or HBeAg/HBeAb seroconversion.
Clinical Trials Related to Alferon N Injection (Interferon Alfa-N3)
A Randomized Phase II Study of Two Doses of Interferon Alfa-2a (IFN Alfa-2a) in Combination With Zidovudine (AZT) and Dideoxycytidine (ddC) Versus AZT and ddC Only in Patients With HIV Infection and Less Than 400 CD4 Cells/mm3 [Completed]
To determine the safety and efficacy of two doses of interferon alfa-2a ( IFN alfa-2a ) in
combination with zidovudine ( AZT )/zalcitabine ( ddC ) versus AZT/ddC only in patients with
HIV infection and CD4 count < 400 cells/mm3.
AZT and ddC inhibit HIV by acting as reverse transcriptase chain terminators, while IFN
alfa-2a inhibits translation of viral proteins. Combining agents that act at different sites
of viral replication may improve HIV inhibition and produce more effective and sustained
anti-HIV effects.
A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Three Preparations of Low-Dose Oral Alpha Interferon in HIV-Infected Patients With CD4+ Counts >= 50 and <= 350 Cells/mm3 [Completed]
To evaluate the effects of three preparations of low-dose oral interferon alpha (i. e.,
Alferon LDO, Veldona, and Ferimmune) on HIV symptoms in HIV-infected patients. To evaluate
differences in response to oral interferon alpha according to gender, race/ethnicity, and use
of antiretrovirals.
Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha
have produced different results, and it is not clear whether the differences were due to the
interferon alpha products used or to problems in the study design. Therefore, three
preparations will be compared to evaluate their potential efficacies.
Double-Blind, Randomized, Dose Ranging Study of Alferon LDO (Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)) in HIV+ Subjects [Completed]
To conduct a double-blind, randomized, dose ranging study of an orally administered low dose
interferon alfa-n3 (IFN-An3) immunomodulator in the treatment of symptomatic HIV+ subjects.
A Study of AZT Plus Human Interferon Alpha in the Treatment of AIDS-Related Kaposi's Sarcoma [Completed]
To evaluate the safety and toxicity of combination therapy for AIDS-associated Kaposi's
sarcoma with zidovudine (AZT) and two kinds of interferon alpha. The two kinds are interferon
alpha (IFN-A) and interferon alpha-2A (recombinant) (IFN-A2A). To define the pharmacokinetics
of AZT and IFN-A or AZT and IFN-A2A when given in combination. To define the maximum
tolerated dose (MTD) of each drug in combination and to define doses to be used in Phase II
trial. AZT has been found to be effective against the effects of HIV in vitro (test tube) and
both interferons have shown antiviral and antitumor effect on Kaposi's sarcoma. It is
reasonable to assume that a synergism and an enhanced antitumor response may be seen with
combination therapy. A study to evaluate the safety and effectiveness of AZT in the
combination with IFN-A2A is warranted.
A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma [Completed]
To evaluate the safety and toxicity of combination therapy for AIDS-associated Kaposi's
sarcoma with zidovudine (AZT) and two kinds of interferon alpha. The two kinds are interferon
alpha (IFN-A) and interferon alpha-2A (recombinant) (IFN-A2A). To define the pharmacokinetics
of both AZT and IFN-A or IFN-A2A when given in combination; to define the maximum tolerated
dose of each drug in combination and to define doses to be used in Phase II trials. AZT has
been found to inhibit both the in vitro (in test tube) and cell killing effects of HIV, and
both interferons (IFN-A and IFN-A2A) have shown antiviral and antitumor effect in Kaposi's
sarcoma. It is reasonable to assume that a synergistic effect and enhanced antitumor response
may be seen with combination therapy. A study to evaluate the safety and efficacy of AZT in
combination with IFN-A or IFN-A2A is warranted.
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