NeoRx Refocusing Resources to Expedite Development of Picoplatin
06 Mayo 2005 - 4:15PM
PR Newswire (US)
NeoRx Refocusing Resources to Expedite Development of Picoplatin
Management to Host Conference Call Monday May 9th at 8:00 a.m.
Eastern SEATTLE, May 6 /PRNewswire-FirstCall/ -- NeoRx Corporation
(NASDAQ:NERX) today announced that it is implementing a strategic
restructuring to refocus its resources to expedite development of
picoplatin (NX 473), a next- generation intravenous platinum
chemotherapeutic agent specifically designed to improve on the
safety and efficacy of existing platinum therapeutics for cancer.
As a result of this restructuring, NeoRx has discontinued the
clinical development of STR for multiple myeloma and other
indications, and will reduce its workforce by approximately 40
percent. The Company also announced plans to cease operations at
its facility in Denton, Texas, where STR was being manufactured.
The Company will redirect its resources to its picoplatin
development program, including the initiation of its planned Phase
II trial of picoplatin in small cell lung cancer in mid-2005, as
well as the initiation of a clinical program in colorectal cancer
by early 2006 and potentially other indications. "While we believe
STR is an innovative cancer therapeutic, a variety of factors
contributed to our decision to discontinue the program and apply
our resources to the development of picoplatin," said Jerry
McMahon, Ph.D., chairman and CEO of NeoRx. "We have recently been
in informal discussions with the FDA to modify the patient
eligibility criteria as a possible means of increasing the slower
than anticipated enrollment in our Phase III trial. Based on these
discussions and other external factors, we concluded that
continuation of STR development would not be economically feasible.
The FDA indicated that it wanted to renegotiate the special
protocol assessment for the current Phase III trial. The changes
mentioned by the FDA would have extended the endpoints of the
trial, increasing the number of patients and the length of follow
up, and thus substantially increasing the time and cost to complete
the trial. This uncertain regulatory situation combined with the
changing treatment landscape have made negotiations with potential
STR partners more challenging than anticipated and finding a
funding partner unlikely." "We believe that picoplatin represents
an exciting and financially attractive product development
opportunity based on its anti-tumor activity to date, the success
of approved platinum agents currently on the market, such as
oxaliplatin and carboplatin, and the relatively well-understood
clinical endpoints and approval pathway for this class of drug,"
said Dr. McMahon. "In addition, encouraging recent data showing the
promise of platinums in combination with targeted cancer agents
provides us with further confidence in our decision to move
picoplatin forward." Earlier this week, the Company signed a
manufacturing and supply agreement with Hyaluron, Inc. for the
production of picoplatin drug product for clinical trials. The
Company currently estimates that it will incur restructuring
charges of approximately $2 million during 2005 and 2006 associated
with the reduction in force and the termination of contracts and
other obligations related to the STR program. This does not include
any potential asset impairment charges and is subject to change as
further analysis is conducted. The Company expects to have a
post-restructuring workforce of approximately 29 employees. As of
March 31, 2005, NeoRx had cash and investment securities of
approximately $16.1 million, and the Company believes that cash is
sufficient to fund operations through 2005. The Company is
continuing to evaluate other areas where additional expenses can be
reduced and is reviewing alternatives with respect to the STR
related assets. The Company will seek additional funding to support
the development of picoplatin. "This decision was difficult because
there are so many talented and dedicated colleagues associated with
the STR program. While many will remain to develop picoplatin, we
want to acknowledge those individuals who will be leaving and thank
them for their important contributions," continued Dr. McMahon.
About Picoplatin Picoplatin is a next-generation platinum compound
specifically designed to improve on the safety and efficacy of
existing platinum therapeutics for cancer. To date, picoplatin has
been evaluated in more than 500 patients in Phase I and II studies
in which picoplatin demonstrated anti-tumor activity in a variety
of solid tumors, including lung, ovarian and hormone refractory
prostate cancer, and showed a manageable safety profile. A Phase II
trial is scheduled to begin in mid-2005 and will evaluate the
single-agent activity of picoplatin in patients with
platinum-resistant small cell lung cancer, the most aggressive and
deadly form of lung cancer. The Company also plans to develop
picoplatin for other cancer indications, initially colorectal
cancer. Conference Call Details Management will host a conference
call beginning at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time)
on Monday, May 9, 2005, to discuss this announcement and answer
questions. To participate in the live call by telephone, please
dial 866-800-8651 from the U.S., and for international callers,
please dial 617-614-2704. The passcode for the call is 10850500.
The live conference call will also be available via the Internet at
http://www.neorx.com/, and a recording of the call will be
available on the Company's Web site for seven business days
following the completion of the call. A telephone replay will be
available following the conclusion of the call by dialing
888-286-8010 from the U.S., or 617-801-6888 for international
callers, and entering passcode 96927361. About NeoRx NeoRx is a
cancer therapeutics development company. The Company currently is
focusing its development efforts on picoplatin (NX 473), a
next-generation platinum therapy that the Company plans to evaluate
in the treatment of patients with advanced lung and colorectal
cancers. For more information, visit http://www.neorx.com/. This
release contains forward-looking statements relating to the
development and commercial potential for picoplatin and STR,
statements about the expected effect of the restructuring on the
Company's future operating results and other statements about our
plans, objectives, intentions and expectations. These statements
are subject to certain risks and uncertainties that could cause
actual results to differ materially from those projected. The words
"believe," "expect," "intend," "anticipate," variations of such
words, and similar expressions identify forward-looking statements,
but their absence does not mean that the statement is not
forward-looking. These statements are not guarantees of future
performance and are subject to certain risks, uncertainties and
assumptions that are difficult to predict. Factors that could
affect the Company's actual results include the risk that we do not
realize the cost savings and other benefits expected to result from
the restructuring; the uncertainty and timing of obtaining
additional financing, obtaining required regulatory approvals,
including delays associated with any approvals that we may obtain,
the initiation, progress and costs of our picoplatin clinical
trials, generating future revenue from product sales or other
sources such as collaborative relationships and future
profitability, our dependence on patents and other proprietary
rights; and the risks and uncertainties described in NeoRx's
current and periodic reports filed with the Securities and Exchange
Commission, including NeoRx's Annual Report on Form 10-K for the
year ended December 31, 2004. Readers are cautioned not to place
undue reliance on forward-looking statements, which speak only as
of the date of this release. The Company undertakes no obligation
to update any forward- looking statement to reflect new
information, events or circumstances after the date of this release
or to reflect the occurrence of unanticipated events. NOTE: NeoRx
and STR are trademarks or registered trademarks of NeoRx
Corporation in the United States and/or foreign countries.
DATASOURCE: NeoRx Corporation CONTACT: Julie Rathbun of NeoRx
Corporation, +1-206-286-2517 Web site: http://www.neorx.com/
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