A randomised, controlled, comparative, open-label, multicenter study on the safety and efficacy of PEG Neutrogen and Neulastim in prevention of chemotherapy-induced neutropenia

Start Date24 Apr 2018

Sponsor / Collaborator

Virchow Biotech Pvt Ltd.

CTRI/2015/12/006426 / CompletedNot Applicable

An open-label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, study comparing pharmacokinetic and pharmacodynamic effects of PEG Neutrogen (pegfilgrastim) of Virchow Biotech, India with that of Neulastim (pegfilgrastim) of Roche following 6 mg subcutaneous injection in healthy, adult human subjects

Start Date13 Nov 2015

Sponsor / Collaborator

Virchow Biotech Pvt Ltd.

100 Clinical Results associated with Pegfilgrastim biosimilar(Virchow Group)

100 Translational Medicine associated with Pegfilgrastim biosimilar(Virchow Group)

100 Patents (Medical) associated with Pegfilgrastim biosimilar(Virchow Group)

Literatures (Medical) associated with Pegfilgrastim biosimilar(Virchow Group)

01 Dec 2009·Clinical Pharmacology & TherapeuticsQ2 · MEDICINE

Comparison of Native E. coli and PEG Asparaginase Pharmacokinetics and Pharmacodynamics in Pediatric Acute Lymphoblastic Leukemia

Q2 · MEDICINE

Article

Author: W Liu ; J C Panetta ; A Gajjar ; C H Pui ; C Cheng ; N Hijiya ; M V Relling ; L J Hak

Asparaginase (ASP) is used routinely in frontline clinical trials for the treatment of childhood acute lymphoblastic leukemia (ALL). The goals of this study were to assess the pharmacokinetics and pharmacodynamics of ASP and to mathematically model the dynamics between ASP and asparagine (ASN) in relapsed ALL. Forty children were randomized to receive either native or polyethylene glycolated (PEG) Escherichia coli ASP during reinduction therapy. Serial plasma ASP and ASN, cerebrospinal fluid (CSF) ASN, and serum anti-ASP antibody samples were collected. The ASP clearance was higher (P = 0.001) for native vs. PEG ASP. Patients with antibodies to PEG ASP had faster PEG ASP clearance (P = 0.004) than did antibody-negative patients. Patients who were positive for antibodies had higher CSF ASN concentrations than did those who were negative (P = 0.04). The modeling suggests that by modifying dosages, comparable ASN depletion is achievable with both preparations. At relapse, there were significant pharmacokinetic and pharmacodynamic differences attributable to ASP preparation and antibody status.

01 Sep 2004·Clinical ScienceQ2 · MEDICINE

Plasma expansion by polyethylene-glycol-modified albumin

Q2 · MEDICINE

Article

Author: AMAURO, Cristine ; HABIB, Robert H. ; ASSALY, Ragheb A. ; HOUTS, Frederick W. ; ZAHER, Aiman ; DIGNAM, J. David ; SHAPIRO, Joseph I. ; KENNEDY, David J. ; AZIZI, Mustafa

Systemic inflammatory response conditions are associated with capillary leak and haemodynamic compromise. Fluid resuscitation to reverse the ensuing hypovolaemia is, however, complicated by the decreased endothelium reflection coefficient to albumin and other colloids. We developed PEG–Alb (albumin covalently linked to polyethylene glycol) as a potential resuscitative agent. PEG was covalently linked to human albumin at multiple sites on the protein. The modified protein was heterogeneous when examined by SDS/PAGE, size-exclusion chromatography and SELDI–TOF MS (surface-enhanced laser-desorption ionization–time of flight MS). Based on size-exclusion chromatography and osmotic pressure data, the effective volume of PEG–Alb is increased 13- to 16-fold compared with unmodified albumin. In an LPS (lipopolysaccharide) model of shock, rats treated with PEG–Alb showed better blood pressure, lower Hct (haematocrit) consistent with haemodilution and less lung injury than rats treated with unmodified albumin or saline. In a CLP (caecal ligation and puncture) model of sepsis, PEG–Alb was more effective than albumin or saline in maintaining blood pressure and in decreasing Hct. When fluorescein-labelled PEG–Alb and Texas Red-labelled albumin were administered to rats with LPS- or CLP-induced shock, PEG–Alb was retained within blood vessels, whereas albumin extravasates into the interstitial space. Based on these data, PEG–Alb appears to be retained within blood vessels in models of capillary leak. PEG–Alb may ultimately be effective in the clinical treatment of shock associated with capillary leak.

100 Deals associated with Pegfilgrastim biosimilar(Virchow Group)

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Indication	Highest Phase	Country/Location	Organization	Date
Neutropenia	Phase 1	-	Virchow Group	-

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