President assumes day to day commercial and development
responsibilities
Cell Therapeutics, Inc. (the "Company")
(Nasdaq: CTIC; MTA) t announced that Craig W. Philips
has assumed his role as CTI's new President, and will
concentrate on managing the company's drug development
and commercial operations. Most recently, Philips was
Vice President and General Manager of Bayer Healthcare
Oncology. He will report to CTI's James A. Bianco, M.D.,
who has served as President and Chief Executive Officer
since its founding and will remain with the company as
CEO.
"Bringing Craig Philips on board at this time represents
a milestone at CTI as the company has shifted from a
research and development organization to a commercial
operating company with the potential to expand the
market indication for Zevalin(R), report pixantrone
pivotal trial results, and potentially file a NDA, as
well as the potential for an OPAXIO(TM) launch in 2009,"
said Bianco.
"With the opportunity to bring two new cancer drugs to
market and expand the label of another in the near term,
CTI could transform itself into a successful commercial
enterprise," said Philips. "I look forward to helping to
bring value to CTI shareholders, and to improving the
treatment options available to individuals suffering
with cancer."
In
late 2007, CTI acquired the U.S. sales and marketing
rights to Zevalin, a drug for treating relapsed
follicular non-Hodgkin's lymphoma (NHL). The full
marketing and sales team has recently come on line, and
Zevalin sales for 2008 are on track at a projected $15
million for the year. Recently, CTI has gained access
rights to Bayer's FIT trial data, and will meet with the
Food and Drug Administration (FDA) in September to
discuss label expansion in the U.S. The phase III
First-line Indolent Trial (FIT) evaluated the benefit
and safety of a single dose of Zevalin in patients with
CD20-positive follicular lymphoma who had achieved a
full or partial remission following first-line
chemotherapy treatment.
In
addition CTI has submitted an application for approval
to market its lung cancer drug candidate OPAXIO in
Europe and expects to receive a response from the
European Medicines Agency (EMEA) regarding that
application in 2009, and also expects final data on
another late stage phase III drug, pixantrone, for
relapsed or refractory aggressive NHL in the second half
of 2008. Positive pixantrone data could allow CTI to
submit an application for FDA approval in early 2009.
OPAXIO is also being studied independently in a phase
III trial for ovarian cancer, with interim data results
expected in late 2009.
Pixantrone is an investigational agent under development
for the potential treatment of various blood cancers. It
was developed to improve the activity and safety of the
anthracycline family of anti-cancer agents and to reduce
the potential for the most common side effects of
anthracyclines, severe cardiotoxicities and cumulative
heart damage.
CTI
has a worldwide licensing agreement with Novartis on
OPAXIO. Novartis also holds an option for an exclusive
license for pixantrone.
CTI
is also developing brostallicin, another cancer drug for
sarcoma currently in phase II/III trials. Brostallicin,
a novel synthetic second- generation DNA minor groove
binder, has potent cancer killing activity and has
demonstrated activity in combination with standard
cytotoxic agents as well as with newer targeted
therapies in preclinical, experimental tumor models.
Since 2006, Philips has been leading Bayer's U.S.
oncology operations following the integration of the
U.S. oncology businesses from Berlex and Bayer. In this
capacity, he oversaw the U.S. oncology operations with
sales of $350 million and a staff of over 150. Philips
was also either a member or chair of alliance executive
committees which included Onyx, Novartis, Genzyme, and
Favrille.
Prior to Bayer Healthcare, Philips was the head of
Berlex Oncology since 2004. He was responsible for the
U.S. oncology operations with sales of over $160
million. Before Berlex, Philips was with Schering Plough
in U.S., and international roles. He began his career
with Bristol Myers, where he worked in a variety of
therapy areas including oncology, cardiology, and CNS.
About Zevalin(R)
Zevalin(R) (Ibritumomab Tiuxetan) is a form of cancer
therapy called radioimmunotherapy and is indicated as
part of the Zevalin therapeutic regimen for treatment of
relapsed or refractory, low-grade or follicular B-cell
non- Hodgkin's lymphoma, including patients with
rituximab refractory follicular NHL. Zevalin is also
indicated, under accelerated approval, for the treatment
of relapsed or refractory, rituximab-naAve, low-grade
and follicular NHL based on studies using a surrogate
endpoint of overall response rate. It was approved by
the FDA in February of 2002 as the first
radioimmunotherapeutic agent for the treatment of NHL.
Rare deaths associated with an infusion reaction symptom
complex have occurred within 24 hours of rituximab (Rituxan(R))
infusions. Yttrium-90 Zevalin administration results in
severe and prolonged cytopenias in most patients. Severe
cutaneous and mucocutaneous reactions have been
reported. The most serious adverse reactions of the
Zevalin therapeutic regimen were primarily hematologic,
including neutropenia, thrombocytopenia and anemia.
Infusion-related toxicities were associated with
pre-administration of rituximab. The risk of hematologic
toxicity correlated with the degree of bone marrow
involvement prior to Zevalin therapy. Myelodysplasia or
acute myelogenous leukemia was observed in 2 percent of
patients (8 to 34 months after treatment). Zevalin
should only be used by health care professionals
qualified by training and experience in the safe use of
radionuclides.
Patients and healthcare professionals can visit http://www.zevalin.com
for more information.
About OPAXIO(TM)
OPAXIO(TM) (paclitaxel poliglumex, CT-2103), which was
previously branded as XYOTAX(TM), is an investigational,
biologically enhanced, chemotherapeutic that links
paclitaxel, the active ingredient in Taxol(R), to a
biodegradable polyglutamate polymer, which results in a
new chemical entity. When bound to the polymer,
paclitaxel is rendered inactive, potentially sparing
normal tissue's exposure to high levels of the active
drug and its associated toxicities. Blood vessels in
tumor tissue, unlike blood vessels in normal tissue, are
porous to molecules like polyglutamate. Based on
preclinical studies, it appears that OPAXIO is
preferentially distributed to tumors due to their leaky
blood vessels and trapped in the tumor bed allowing
significantly more of the dose of chemotherapy to
localize in the tumor than with standard paclitaxel.
Once inside the tumor cell, enzymes metabolize the
protein polymer, releasing the paclitaxel chemotherapy.
Preclinical and clinical studies support that OPAXIO
metabolism by lung cancer cells may be influenced by
estrogen, which could lead to enhanced release of
paclitaxel and efficacy in women with lung cancer
compared to standard therapies. This is being studied in
an ongoing phase III trial.
About Pixantrone
Pixantrone (BBR 2778), a DNA intercalating antitumor
agent that contains an aza-anthracenedione molecular
structure, differentiating it from anthracycline
chemotherapy agents, was discovered by our scientists in
Bresso, Italy, 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 Brostallicin
Brostallicin, a novel synthetic second-generation DNA
minor groove binder, has potent cancer killing activity
and has demonstrated synergism in combination with
standard cytotoxic agents as well as with newer targeted
therapies in preclinical experimental tumor models.
Brostallicin binds covalently to DNA within the DNA
minor groove, interfering with DNA division and leading
to tumor cell death. More than 200 patients have been
treated with brostallicin in single-agent and
combination studies. Brostallicin had predictable and
predominantly hematologic toxicities. Activity was
demonstrated in a number of solid tumor types. A phase
II study of brostallicin in relapsed/refractory soft
tissue sarcoma met its pre-defined activity and safety
hurdles and resulted in a first-line phase II study that
is currently being conducted by the European
Organization for Research and Treatment of Cancer
(EORTC).
About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is caused by the abnormal
proliferation of white blood cells and normally spreads
through the lymphatic system, a system of vessels that
drains fluid from the body. NHL can be broadly
classified into two main forms -- aggressive NHL, a
rapidly spreading acute form of the disease, and
indolent NHL, which progresses more slowly. According to
the National Cancer Institute's SEER database there were
nearly 400,000 people in the U.S. with NHL in 2004. The
American Cancer Society estimates that 66,120 people
will be diagnosed with NHL in 2008 and more than 19,000
are expected to die.
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.CellTherapeutics.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
Zevalin, OPAXIO, pixantrone and brostallicin include
risks associated with preclinical and clinical
developments in the biopharmaceutical industry in
general and with Zevalin, OPAXIO, pixantrone and
brostallicin in particular including, without
limitation, the ability of the Company to continue to
raise capital to fund its ongoing operations, or the
potential failure of Zevalin to be approved by the FDA
for first-line treatment of non-Hodgkin's lymphoma, the
failure of OPAXIO, pixantrone or brostallicin to prove
safe and effective for their intended uses, a
determination by the EMEA that OPAXIO should not be
approved for sale in Europe, other determinations by
regulatory, patent and administrative governmental
authorities, competitive factors, technological
developments, costs of developing, producing and selling
Zevalin, OPAXIO, pixantrone and brostallicin, the risk
that Novartis may not elect to participate in the
development and marketing of OPAXIO or may not exercise
its option with regard to 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 Italian law, CTI is under no
obligation to (and expressly disclaims any such
obligation to) update or alter its forward-looking
statements whether as a result of new information,
future events, or otherwise.
Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
F: 206.272.4434
E: media@ctiseattle.com
http://www.celltherapeutics.com/media.htm
Investors Contact:
Ed Bell
T: 206.282.7100
Lindsey Jesch
T: 206.272.4347
F: 206.272.4434
E: invest@ctiseattle.com
http://www.celltherapeutics.com/investors.htm
SOURCE Cell Therapeutics, Inc.
http://www.celltherapeutics.com
