Results Presented at International Cancer Meeting
VANCOUVER, British Columbia and HOUSTON, Dec. 6 /PRNewswire/ -- Inex
Pharmaceuticals Corp. (Toronto: IEX) and The University of Texas M. D.
Anderson Cancer Center announced today final results from a M. D. Anderson
phase IIa clinical trial of INEX's anti-cancer drug candidate Onco TCS that
demonstrated the drug is effective for shrinking tumors in patients with
relapsed non-Hodgkin's lymphoma (NHL), an aggressive form of blood cancer.
The Onco TCS results were reported on Saturday December 4th to physicians
and scientists attending the meeting of the American Society of Hematology in
New Orleans. The presentation was given by Dr. Andreas Sarris, lead
investigator for the phase IIa trial carried out at The University of Texas
M. D. Anderson Cancer Center in Houston.
"Onco TCS holds promise for treating relapsed aggressive and transformed
non-Hodgkin's lymphoma patients having achieved over a 40% response rate with
mild and manageable toxicities," Dr. Sarris said. "Our experience and others
have shown that other single chemotherapeutic agents are not expected to
achieve this level of response rate in similar patients without having severe
or unacceptable toxicities."
"These results support further studies and suggest that Onco TCS should be
evaluated in the first-line treatment of non-Hodgkin's lymphoma," Dr. Sarris
added.
In New Orleans, Dr. Sarris reported results from 68 total evaluable NHL
patients, 50 of whom suffered from the aggressive or transformed type of the
disease. Analysis of 38 patients with aggressive NHL and 12 patients with
transformed NHL provided a 45% and 42% response rate, respectively. The
additional 18 patients had other types of NHL and did not experience
significant response rates to the treatment.
David Main, President and CEO of INEX, said these results support INEX's
expanded development plans of Onco TCS. INEX is commencing a pivotal phase
II/III clinical trial to continue its evaluation of Onco TCS as a treatment
for second-relapsed aggressive NHL. Approximately 100 patients will be
enrolled at as many as 12 medical centers across North America, including
M. D. Anderson. The trial is designed to providnt data to seek
marketing approval in the U.S. and Canada in late 2001.
The United States Food and Drug Administration (FDA) has given Onco TCS
Investigational New Drug (IND) status and permission to proceed with the
pivotal II/III trial to include medical centers in the U.S. INEX has applied
to the Therapeutics Product Programme of Health Canada for permission to
include Canadian medical centres in the trial.
Onco TCS is a proprietary drug comprised of the widely-used off-patent
cancer drug vincristine encapsulated in the company's patented drug delivery
technology, Transmembrane Carrier Systems (TCS). The TCS technology provides
prolonged blood circulation, tumor accumulation and extended drug release at
the cancer site designed to increase the effectiveness and reduce the
toxicities of the encapsulated drug.
In each of the patients who responded to Onco TCS treatment, the size of
the tumors was reduced by at least 50%. All patients have relapsed following
an average of three prior treatments with other chemotherapeutics, including
vincristine. Vincristine has been widely used in a four drug "cocktail" as a
first-line treatment for NHL for a number of years.
In addition to the pivotal phase II/III trial in second relapsed
aggressive NHL patients, INEX and M. D. Anderson are planning a new phase I/II
clinical trial in 2000 to evaluate Onco TCS as a replacement for vincristine
in primary treatment for NHL in combination with the other front-line drugs.
NHL is the most common form of lymphoma. It is the fifth-leading cause of
cancer deaths in Canada (2,500 in 1999) and the sixth-leading cause of cancer
deaths in the United States (26,000 in 1999), according to estimates of the
national cancer institutes in Canada and the U.S. More than 300,000 people
suffer from the disease in the two countries and approximately 62,000 new
cases will be diagnosed in 1999. Approximately 50% of the newly-diagnosed
cases are categorized as the aggressive form of NHL.
M. D. Anderson Cancer Center is one of the largest and most respected
cancer centres in the United States. It is devoted to cancer patient care,
research, education and prevention.
INEX is a Canadian biopharmaceutical company that utilizes proprietary
drug delivery systems and therapeutic compounds to increase the effectiveness
and reduce side-effects of anti-cancer therapies. INEX is focused on
commercializing products for unmet needs of the oncology market.
SOURCE Inex Pharmaceuticals Corp.
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Related links:
http://www.inexpharm.com
CONTACT:
Ian Mortimer, Investor Relations for Inex
Pharmaceuticals Corp., 604-419-3200, or info@inexpharm.com; or
press, Karen Cook Boas, 604-739-7500, or kcook@hoggan.com, or
Kirsten McLellan, 604-739-7500, both of James Hoggan & Associates
Inc., for Inex Pharmaceuticals Corp.; or Kris Muller, Senior
Communications Specialist of M. D. Anderson Cancer Center,
713-792-0665
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