CytRx Corporation : CytRx's Tamibarotene Continues to Protect Touring Professional Musician and Former NBA Player Ray Johnston from Leukemia
07/17/2012| 08:35am US/Eastern
Johnston celebrates more than two years leukemia-free following total
disease eradication with CytRx drug candidate tamibarotene
Leads active life of country/rock musician with The Ray Johnston Band -
For more than two years, former Dallas Maverick basketball player Ray
Johnston has been cancer-free. His advanced, highly aggressive acute
promyelocytic leukemia (APL) was totally eradicated in 2010, just four
months after beginning treatment with CytRx Corporation's (NASDAQ:CYTR)
cancer drug candidate tamibarotene. Since then, Mr. Johnston has
continued taking tamibarotene tablets every other month to guard against
"Every day without leukemia is a celebration," said Mr. Johnston, who
leads a very active lifestyle with the band he formed following his
diagnosis. The Ray Johnston Band is booking about 100 shows across the
U.S. this year with a sound described by Johnston as halfway between Zac
Brown and Dave Matthews.
Tamibarotene was developed to be more potent and avoid some of the toxic
side effects of all trans-retinoic acid (ATRA)--the current first-line
treatment for APL. CytRx is currently testing tamibarotene as a
third-line treatment for this form of leukemia.
CytRx also is evaluating tamibarotene in combination with other
chemotherapeutic agents in a late-stage, global Phase 2b clinical trial
as a first-line treatment for non-small cell lung cancer (NSCLC).
Positive signs of efficacy in patients with APL such as Ray Johnson
further bolster the case for tamibarotene's drug activity, providing
hope for its success in patients with lung cancer, which is responsible
for more deaths than breast, prostate and ovarian cancers combined. Last
month an independent group of oncologists and biostatistitions who
comprise the Data Safety Monitoring Board for this global trial
recommended moving forward with clinical testing following an interim
review of safety data. The Company expects to report trial results next
Mr. Johnston was diagnosed with APL at the age of 24, ending his brief
career as a professional basketball player with the Dallas Mavericks.
For the following six years, he was treated with multiple therapies for
APL approved by the U.S. Food and Drug Administration (FDA), including
ATRA, as well as anthracycline chemotherapy, Mylotarg® and arsenic
trioxide (ATO). He even underwent a blood stem cell transplant. Although
his leukemia went into remission several times, it always came back with
a vengeance. In fact, a PET scan performed just prior to his treatment
with tamibarotene showed more than 30 tumors throughout his body.
In December 2009, his physician, Dr. Robert Collins at the University of
Texas Southwestern Medical Center, requested tamibarotene from CytRx on
a compassionate use basis. The FDA and CytRx granted the request.
"Two years ago when I was 31, I asked Dr. Collins if I'd reach 33. His
answer then was 'unless we find a new drug, I don't think so.' But here
I am," said Mr. Johnston.
"We are delighted that Ray continues to show no signs of leukemia," said
Steven A. Kriegsman, CytRx President and CEO. "Our corporate goal is to
improve treatments for people with cancer. We are grateful to be a part
of the success that Ray has achieved and hope that tamibarotene can help
those suffering from NSCLC."
Mr. Johnston has also achieved success with his band. The Ray Johnston
Band has been featured on Dallas Mavericks' owner Mark Cuban's HDNet
reality series, The Ray Johnston Band Road Diaries, and has opened for
world renowned performers such as Jimmy Buffet, Cheap Trick, The Cure,
The Fray, and Los Lonely Boys.
Tamibarotene is an orally available, rationally designed, synthetic
retinoid compound. CytRx holds the North American and European rights to
tamibarotene as a treatment for APL and certain other cancers.
Tamibarotene was approved in Japan in 2005 where it is marketed as a
second-line treatment for APL.
In December 2010, CytRx initiated a global Phase 2b clinical trial in
patients with advanced NSCLC. In this randomized clinical trial,
patients with advanced NSCLC are treated with paclitaxel plus
carboplatin and either tamibarotene or placebo. The primary objective of
this trial is to determine the objective response rate (complete and
partial responses) and progression-free survival. Secondarily, the trial
will evaluate overall survival, quality-of-life and examine the
pharmacokinetics of tamibarotene in this population, among other
The efficacy and safety of tamibarotene as a third-line treatment for
APL is currently being evaluated in the Phase 2 STAR-1 registration
trial, which is being conducted under a Special Protocol Assessment
(SPA). In June 2009 CytRx reported that, of the 11 patients enrolled in
the STAR-1 trial at that time, three (27%) achieved a hematologic
complete response, and four (36%) a morphologic leukemia-free state. In
December 2009, favorable preliminary results from the STAR-1
registration trial were presented at the Annual Meeting of the American
Society of Hematology (ASH).
The FDA has granted Orphan Drug Designation for APL and Fast Track
Designation for the use of tamibarotene in patients with relapsed or
refractory APL following treatment with ATRA and ATO. In addition,
tamibarotene has been granted orphan medicinal product status by the
European Medicines Agency for the treatment of APL.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development
company specializing in oncology. The CytRx oncology pipeline includes
three programs in clinical development for cancer indications: aldoxorubicin
(formerly known as INNO-206), tamibarotene
With its tumor-targeted doxorubicin conjugate aldoxorubicin, CytRx has
initiated an international Phase 2b clinical trial as a treatment for
soft tissue sarcomas, has completed its Phase 1b/2 clinical trial
primarily in the same indication, recently initiated a Phase 2 trial for
patients with advanced pancreatic ductual adenocarcinomas, and plans to
meet with the FDA in the second half of 2012 to discuss a potential
Phase 3 pivotal trial as a therapy for patients with soft tissue
sarcomas whose tumors have progressed following treatment with
chemotherapy. CytRx's pipeline also includes tamibarotene, which it is
testing in a double-blind, placebo-controlled, international Phase 2b
clinical trial in patients with non-small-cell lung cancer, and which is
in a Phase 2 clinical trial as a treatment for acute promyelocytic
leukemia (APL). The Company completed its evaluation of bafetinib in the
ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic
leukemia (B-CLL), and plans to seek a partner for further development of
bafetinib. For more information about the Company, visit www.cytrx.com.
This press release contains forward-looking statements within the
meaning of Section 21E of the Securities Exchange Act of 1934, as
amended. Such statements involve risks and uncertainties that could
cause actual events or results to differ materially from the events or
results described in the forward-looking statements, including risks
relating to possible reappearance of cancer in the patient described in
this press release, the failure of other patients to response to our
drug candidate or possible unreported cases of adverse patient outcomes,
the ability to obtain regulatory approval for clinical testing of
tamibarotene, including additional clinical trials for patients with
APL, the scope of clinical testing that may be required by regulatory
authorities and the timing and outcome of further clinical trials, the
risk that any future human testing of tamibarotene might not produce
results similar to those seen in animals, risks related to CytRx's
ability to manufacture tamibarotene and its other drug candidates in a
timely fashion, cost-effectively or in commercial quantities in
compliance with stringent regulatory requirements, risks related to
CytRx's need for additional capital or strategic partnerships to fund
its ongoing working capital needs and development efforts, including any
future clinical development of tamibarotene, and the risks and
uncertainties described in the most recent annual and quarterly reports
filed by CytRx with the Securities and Exchange Commission and current
reports filed since the date of CytRx's most recent annual report. All
forward-looking statements are based upon information available to CytRx
on the date the statements are first published. CytRx undertakes no
obligation to publicly update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
Legend Securities, Inc.
© Business Wire 2012