Preliminary data from a number of clinical trials on the use ofrecombinant human interleukin-6 (rhIL-6) alone or incombination with other growth factors may be safe, well-tolerated and even effective in stimulating the production ofplatelets in patients undergoing cancer chemotherapy.
The results of the trials, sponsored by the CytokineDevelopment Unit (CDU) of Sandoz Pharmaceuticals Corp., werepresented Monday at the 35th Annual American Society ofHematology (ASH) meeting in St. Louis.
In a Phase I/II trial on patients with advanced non-small celllung cancer who had received chemotherapy, the combinationtherapy of IL-6 and granulocyte-colony stimulating factor (G-CSF) appeared to be well-tolerated. According to clinicalinvestigator Jeffrey Crawford of Duke University MedicalCenter, the combination therapy also appeared to reduce theseverity of thrombocytopenia and neutropenia in thesepatients.
In addition, the concomitant administration of IL-6 withgranulocyte macrophage-colony stimulating factor (GM-CSF)following autologous bone marrow transplantation for treatingbreast cancer appeared to be well-tolerated by the 10 patientsinvolved in a Phase I trial.
Separately, researchers found that IL-6 alone was well-tolerated by 25 sarcoma patients both before and afterchemotherapy. The Phase I/II trial was led by George Demetriof the Dana-Farber Cancer Institute.
"Based on positive Phase I/II results, we plan to initiate PhaseIII studies of IL-6 in the first quarter of 1994," said Dan Levitt,executive director of Sandoz's CDU.
Researchers associated with Sandoz's CDU of East Hanover, N.J.,are also conducting clinical trials on a combination therapy thatinvolves the sequential administration of cytokinesinterleukin-3 (IL-3) and GM-CSF. Data from those trials alsowere presented at the ASH meeting on Monday.
"Recent trials have demonstrated encouraging evidence thatsequential administration of IL-3 and GM-CSF may be moreeffective at stimulating biologic activity and better-toleratedthan concurrent administration of IL-3 and late-actingcytokines," said investigator Joseph Fay of Baylor UniversityMedical Center. "Additional clinical results reported at ASHhave also indicated that IL-3 can act as an early stimulator ofprogenitor cells," he added.
With the exception of rhG-CSF, which Sandoz buys from AmgenInc., the recombinant human cytokines CDU is using in its trialswere originally identified and cloned by scientists fromGenetics Institute Inc. Sandoz holds the worldwide marketingrights from GI for IL-3 and IL-6, and is GI's licensee for GM-CSF, which it sublicensed to Schering-Plough Corp.
-- Jennifer Van Brunt Senior Editor
(c) 1997 American Health Consultants. All rights reserved.