Nuvelo Initiates Phase II Clinical Trial in Acute Peripheral Arterial Occlusion
Tuesday June 24, 6:30 am ET
SUNNYVALE, Calif., June 24 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq:
NUVO - News) today announced the commencement of dosing in a Phase II
trial with its lead product candidate, alfimeprase, for the treatment of acute
peripheral arterial occlusion (PAO).
The multi-center,
open-label, dose-escalation
study will evaluate the
safety and efficacy of
alfimeprase in patients
suffering from acute PAO.
Dr. Kenneth Ouriel,
chairman of the department
of vascular surgery at the
Cleveland Clinic, and Dr.
Jacob Cynamon, professor
of clinical radiology and
director of the division of
vascular and interventional
radiology at the Montefiore
Medical Center, will serve
as the principal
investigators of the study
that will compare three different doses of alfimeprase in approximately 100
patients across twenty centers in the United States, Europe and South Africa.
"Current treatment options are limited for patients suffering from PAO," stated
Dr. Ouriel. "One established treatment, bypass surgery, is associated with a
significant risk to the patient's life as PAO generally occurs in elderly or
medically compromised individuals, poorly able to withstand a major operation.
Thrombolytic therapy provides a less-invasive alternative, with the potential to
re-open the blood vessel without the need for open surgery."
"Our clinical development program with alfimeprase is right on track," stated
Dr. Ted W. Love, president and chief executive officer of Nuvelo. "The Phase II
study design is intended to demonstrate clear patient benefit with the rapid
dissolution of clots, in addition to enabling us to further establish the safety of
alfimeprase. We will continue to support the advancement of this compound
through the clinic and onto the market in addition to further advancing Nuvelo's
internal development programs in secreted proteins and immunotherapeutics."
Nuvelo is also currently conducting an additional Phase II trial to evaluate
safety and efficacy of alfimeprase in catheter occlusion. This trial began earlier
this month and the company expects to complete at least one of these Phase II
trials by the end of 2003.
About Alfimeprase
Alfimeprase is a modified fibrolase that directly degrades fibrin when delivered
through a catheter at the site of a blood clot. Compared to traditional
plasminogen activators, pre-clinical studies have shown alfimeprase to be up
to six times faster in dissolving clots. In addition, alfimeprase's novel
mechanism of action dramatically limits the molecule's systemic activity,
reducing the risk of bleeding complications, a common side-effect of current
therapies.
Alfimeprase was identified through Amgen's research program and partnered
with Nuvelo in January 2002 for development and commercialization. Under the
terms of the collaboration, Nuvelo will lead all clinical development activities
and Amgen will have the first right to manufacture alfimeprase. Amgen will
have the option to lead the commercialization efforts in which both companies
may participate. Both Amgen and Nuvelo share worldwide commercial rights.
About PAO
PAO affects more than 100,000 people annually in the U.S. alone and occurs
when arterial blood flow is blocked to an extremity of the body by a clot. PAO
usually occurs in the leg and is the result of underlying peripheral arterial
disease (PAD), in which chronic fatty plaque buildup restricts blood flow. The
classic early symptom of PAD is leg pain or fatigue during activity that subsides
with rest. Acute PAO is due to an occlusive blood clot which results in the total
blockage of flow. If blood flow is not restored, this can lead to ulcers,
gangrene, tissue death and ultimately to foot or leg amputation.
Bypass surgery and angioplasty are established treatments for PAO; however
treatment with thrombolytic drugs has presented a less-invasive and more
cost-effective alternative. There are currently no products on the market widely
used to treat PAO. With the limited treatment options currently available,
alfimeprase has received orphan drug designation for the PAO indication.
About Catheter Occlusion
Catheter occlusion is the obstruction of flow through a central venous catheter
by a blood clot. This impairs the ability to infuse medications or other fluids
through the catheter. It is estimated that about five million catheters are placed
in patients each year in the U.S., of which approximately 20-25% become
occluded. As these catheters are primarily inserted in patients receiving
life-saving medications such as chemotherapy, it is critical to restore flow
through the catheter in a timely and cost-effective manner with minimal risk to
the patient. In many cases, restoring flow is preferred over replacement of the
catheter for several reasons including: limited interruption of therapy, reduced
risk of trauma to the patient, reduced risk of complications and decreased
cost. Treatment with thrombolytic drugs represents a less-invasive and more
cost-effective alternative to replacement. Current treatment options include
surgery to replace the catheter or treatment with Cathflo®Activase®, a
recombinant form of a naturally-occurring enzyme, t-PA.
About Nuvelo
Nuvelo, Inc., formed by the merger of Hyseq Pharmaceuticals, Inc. and
VARIAGENICS, Inc., is engaged in the discovery, development and
commercialization of life improving therapeutics for the treatment of human
disease. Nuvelo's lead product candidate, alfimeprase, is partnered with
Amgen and has entered two Phase II trials in both peripheral arterial occlusion
and catheter occlusion. Additional programs include drug discovery focused
on immunotherapeutics and secreted proteins.
Information about Nuvelo is available at our new Web site at www.nuvelo.com
or by phoning 408-215-4000.
Statements contained in this press release which are not historical in nature,
are intended to be, and are hereby identified as "forward-looking statements"
for purposes of the safe harbor provided by the Private Securities Litigation
Reform Act of 1995. Forward-looking statements may be identified by words
such as "believe," "expect," "anticipate," "should," "may," "estimate," "goals,"
and "potential," among others. Such statements are based on our
management's current expectations and involve risks and uncertainties. Actual
results and performance could differ materially from those projected in the
forward-looking statements as a result of many factors, including, without
limitation, the risk that we may not successfully integrate the VARIAGENICS
business following our recent merger, uncertainties relating to drug discovery,
clinical development processes and the development and commercialization of
our molecular diagnostics technology, changes in relationships with strategic
partners and dependence upon strategic partners for the performance of
critical activities under collaborative agreements, the impact of competitive
products and technological changes, uncertainties relating to patent protection
and regulatory approval and uncertainties relating to our ability to obtain
substantial additional funds required for progress in drug discovery and
development. These and other factors are identified and described in more
detail in Nuvelo, Hyseq and VARIAGENICS filings with the SEC, including and
without limitation, Nuvelo's annual report on Form 10-K and the related Form
10-K/A for the year ended December 31, 2002. We disclaim any intent or
obligation to update these forward-looking statements. |
