This study is a prospective, open-label, multicentre study. Hundred eligible patients with stage III or IV non-Hodgkin lymphoma (NHL) or acute lymphoblastic leukemia (ALL) with a peripheral white blood cell (WBC) count of > 25,000/µL or any leukemia or lymphoma with plasma uric acid level of at least 8 mg/dL will be treated with rasburicase 0.20 mg/kg body weight intravenously for 4 days. The primary endpoints viz., the percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy, plasma uric acid AUC 0-96 hr and incidence of adverse events will be assessed during 11 days study period.

Start Date01 Feb 2010

Sponsor / Collaborator

Virchow Group

100 Clinical Results associated with Rasburicase biosimilar(Virchow Group)

100 Translational Medicine associated with Rasburicase biosimilar(Virchow Group)

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

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

01 Sep 2003·Journal of ImmunotherapyQ4 · MEDICINE

A Pilot Trial of Tumor Lysate-Loaded Dendritic Cells for the Treatment of Metastatic Renal Cell Carcinoma

Q4 · MEDICINE

Article

Author: Moldawer, Nancy ; Belldegrun, Arie S ; Mulders, Peter ; Hinkel, Andreas ; Chao, Debby H ; Gitlitz, Barbara J ; Pantuck, Allan J ; Zisman, Amnon ; Tso, Cho-Lea ; Figlin, Robert A

Cultured tumor lysate-loaded dendritic cells (TuLy-DC) have been demonstrated in vitro to stimulate potent immune modulations and generate significant antitumor response. We report the results of a pilot trial of TuLy-DC vaccine for patients with metastatic renal cell carcinoma (mRCC). Fourteen mRCC patients underwent nephrectomy to obtain autologous TuLy prepared by subjecting tumor cells to 3 freeze/thaw cycles. Dendritic cells were generated from peripheral blood CD14+ precursors cultured in the presence of GM-CSF, IL-4, and 10% autologous serum. Patients received one vaccination of TuLy alone as an immunologic control, followed by 3 weekly vaccinations of DC-TuLy injected intradermally in the midaxillary region. Peripheral blood lymphocytes were collected before and after weekly vaccines and were assessed for changes in phenotype, cytotoxicity, and cytokine profile. The TuLy-DC vaccine was successfully prepared and administered to 12 patients, whereas 2 patients did not receive vaccine treatment due to declines in postoperative performance status. The vaccines were well tolerated, with only grade 1 toxicities noted. One patient had a partial response to treatment that did not correspond to any significant change in immunologic profile. This pilot trial demonstrated both the safety and feasibility of reliably preparing a DC-based vaccine for mRCC patients. Our data suggest that autologous TuLy-DC vaccines generate only limited clinical response. Further clinical studies are needed to identify the most potent treatment regimen that can consistently mediate an antitumor immune response in vivo.

11 Nov 2002·The Medical letter on drugs and therapeuticsQ4 · MEDICINE

Rasburicase (elitek) for hyperuricemia.

Q4 · MEDICINE

Article

01 Nov 2002·Journal of ImmunotherapyQ4 · MEDICINE

Vaccination of Patients With Metastatic Renal Cell Carcinoma With Autologous Dendritic Cells Pulsed With Autologous Tumor Antigens in Combination With Interleukin-2: A Phase 1 Study

Q4 · MEDICINE

Article

Author: Mulders, Peter F. A. ; Bleumer, Ivar ; Tiemessen, Dorien M. ; Adema, Gosse J. ; Jongmans, Wim ; Debruyne, Frans M. J. ; de Mulder, Pieter H. ; de Vries, I. Jolanda M. ; Oosterwijk-Wakka, Jeannette C. ; Oosterwijk, Egbert

Dendritic cells (DC) have been recognized as the most potent antigen presenting cells (APC) of the immune system. We performed a phase 1 study in twelve patients with metastatic renal cell carcinoma (RCC) using autologous immature DC loaded with autologous tumorlysate (TuLy) as a vaccine based on our earlier in vitro observations that such DC can activate tumor-specific cytotoxic T-lymphocytes. The treatment was combined with low-dose interleukin (IL)-2, as this has shown benefit in DC-based therapies. Patients received three intradermal vaccinations at two weekly intervals, and, after each vaccination, IL-2 was administered for 5 consecutive days. In six patients, keyhole-limpet hemocyanin (KLH) was added to the DC culture for immunologic monitoring purposes. In general, DC phenotype was CD14(low), CD86(high), CD40(high), CD80(low), and CD83(low). We noticed that the number of CD14+ cultured DC increased during treatment. Nevertheless, ovalbumin uptake remained high, underlining that these cells were still functional immature DC. The vaccine was able to elicit cellular anti-KLH responses, emphasizing the ability of the injected DC to mount an immunologic response. However, proliferative responses against TuLy were not detected, and humoral responses against TuLy or KLH were absent. Objective clinical responses were not observed, but extended stable disease was noted. The absence of cellular, humoral, or clinical antitumor responses suggests that the vaccination strategy with immature DC has little benefit for patients with advanced RCC. Nevertheless, this study shows the feasibility of a completely autologous DC and tissue culture methodology for the generation of TuLy pulsed DC.

100 Deals associated with Rasburicase biosimilar(Virchow Group)

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Indication	Country/Location	Organization	Date
Hyperuricemia	IN	Virchow Group	28 Aug 2012

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