Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced that its
investigational drug pixantrone will be studied in a multicenter phase I/II
trial initiated by the Fondation Charcot Stichting, in Brussels, Belgium, which
sponsors a consortium of centers involved in studying new therapies for the
treatment for multiple sclerosis. This study will enroll patients with
aggressive relapsing remitting (RR) or secondary progressive (SP) multiple
sclerosis (MS). Mitoxantrone, a related compound which is less active in
preclinical studies, has been approved by the U.S. Food and Drug Administration
(FDA) for the reduction of neurological disability and/or frequency of clinical
response in patients with SP MS. A phase III trial with pixantrone in relapsed
aggressive non-Hodgkin's lymphoma (NHL) is near completion.
"Despite the
availability of newer biologic agents, drugs such as mitoxantrone remain an
important therapy in relapsing MS. Long term cardiotoxicity remains a major
drawback to treating multiple sclerosis with mitoxantrone and imposes a
limitation both for selection of patients and for the duration of the
treatment," said R.E. Gonsette, M.D., Chairman Fondation Charcot Stichting and
principal investigator of the study. "In addition to the potential for lower
cardiac toxicity, preclinical studies suggest that pixantrone may provide more
effective immune regulation than mitoxantrone, the only currently approved
cytotoxic agent for treating MS."
The investigator-sponsored trial (IST)
will enroll 20 patients in Belgium, France and Germany.
About the
StudyTwenty patients with aggressive RR MS or SP MS who failed to
respond to approved immunomodulatory agents (interferons, glatiramer acetate)
will be included. The objectives of the study are to determine the efficacy of
pixantrone as an immunosuppressive agent based on its ability to decrease the
lymphocyte count and to evaluate efficacy in MS based on gadolinium enhanced
magnetic resonance imaging. This trial is an open-label, multi-center,
non-comparative study of pixantrone administered at a dose of 120 mg/m2 once
every 21 days (3 weeks). Four consecutive three-week courses of pixantrone will
be administered in order to determine if this regimen results in lymphopenia of
less than or equal to 1000/mm3. The doses and the number of infusions will be
adapted to leukocyte, granulocyte and thrombocyte counts and possibly
reduced.
About PixantronePixantrone (BBR 2778) is a novel
DNA major groove binder that contains an aza-anthracenedione molecular
structure, differentiating it from anthracycline chemotherapy agents. A new
chemical compound for the treatment of non-Hodgkin's lymphoma (NHL), and various
other hematologic malignancies, solid tumors, and immunological disorders,
pixantrone is being developed by CTI to improve the activity and safety in
treating cancers usually treated with the anthracycline family of anti-cancer
agents. Anthracyclines have been shown to be very active clinically in a number
of tumor types, such as lymphoma, leukemia, and breast cancer. For these
diseases, anthracycline-containing chemotherapy regimens are effective in
first-line (initial) treatment. However, they may cause cumulative heart damage
that limits lifetime dosage and does not allow for retreatment. Pixantrone has
been designed to reduce the potential for heart damage compared to currently
available anthracyclines or anthracenediones without a loss in anti-tumor or
immunomodulatory activities.
About Cell Therapeutics,
Inc.Headquartered in Seattle, CTI is a biopharmaceutical company
committed to developing an integrated portfolio of oncology products aimed at
making cancer more treatable. For additional information, please visit
http://www.cticseattle.com.
This press release includes
forward-looking statements that involve a number of risks and uncertainties, the
outcome of which could materially and/or adversely affect actual future results.
Specifically, the risks and uncertainties that could affect the development of
pixantrone and the risks related to this clinical trial include risks associated
with preclinical and clinical developments in the biopharmaceutical industry in
general and with pixantrone in particular including, without limitation, the
potential failure of pixantrone to prove safe and effective for treatment of
multiple sclerosis, the identification of new risks or limitations of pixantrone
that may be discovered in this Investigator Sponsored Trial, determinations by
regulatory, patent and administrative governmental authorities, competitive
factors, technological developments, costs of developing, producing and selling
pixantrone, and the risk factors listed or described from time to time in the
Company's filings with the Securities and Exchange Commission including, without
limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q.
Except as may be required by law, CTI does not intend to update or alter its
forward-looking statements whether as a result of new information, future
events, or otherwise.
Cell Therapeutics, Inc.
http://www.cticseattle.com
