MissionIR Releases Exclusive Audio Interview With CytRx Management
ATLANTA, GA -- (Marketwired) -- 11/07/13 -- MissionIR today
announces the online availability of its interview with CytRx Corp.
(NASDAQ: CYTR) President and Chief Executive Officer Steven
Kriegsman, as well as the company's Vice President of Business
Development and Investor Relations David Haen. The full audio
interview is available at: http://cytr.missionir.com/interview.html.
CytRx is a biopharmaceutical R&D company developing cancer drugs for
several indications. The company's primary focus is on its
proprietary delivery technology for potent oncology therapies.
The company's lead candidate, aldoxorubicin, is an improved version
of the widely used chemotherapy agent, doxorubicin. A pivotal Phase 3
trial with a special protocol assessment is scheduled to begin in the
first quarter of 2014 and top-line Phase 2b results are expected in
December 2013. These are just a few developments in the company's
pipeline, which are further detailed in the interview.
"We have a technology that allows us to optimize chemotherapy agents
as well as other anti-cancer agents," Haen stated in the interview,
describing aldoxorubicin and reinforcing Kriegsman's statements.
"We're not seeing nearly the systemic toxicity one typically thinks
of when you hear of chemotherapy... here we think we have a way to
optimize it. Aldoxorubicin is really the proof of principal and the
goal is to work with our collaborators in Freiburg, Germany, to
develop additional molecules based on other chemotherapy payloads.
Kriegsman and Haen discuss their own backgrounds and experience in
the industry, as well as detail the rest of the company's management
Wrapping up the interview, Kriegsman highlights 2013 achievements and
provides insight to recent company news and important upcoming
Welcome one, welcome all, to this online business
briefing where we shine a spotlight on today's smartest plays in the
market. Today we are speaking with CytRx Corporation. The company is
traded on the NASDAQ CM market under the ticker symbol CYTR. We are
joined by two guests from the company. The President and CEO of the
company, Steven Kriegsman, as well as David Haen. He's the Vice
President of Business Development and Investor Relations. Let's go
ahead and welcome Steven. First Steven, how you doing today?
Very well, Stuart.
Thank you so much for taking your time. And David,
let's hear from you. How are you doing out there in Los Angeles
Doing well, thank you sir.
Alright. Great. Thank you, gentlemen for taking time
from your busy schedule to stop by and speak to your shareholders as
well as the listeners to this program. For those listeners that may
not be familiar with your company yet. Steven, if you would, tell us
a little bit about the company's business model and market.
Well, we're a pure play oncology company. We
develop cancer drugs for a number of different indications. And we
have focused on the enhanced delivery of potent oncology therapies.
We have a proprietary delivery technology with demonstrated efficacy.
You know, that's a platform for many different drugs and many
different cancers, both hematological cancers, and solid tumors. We
have a late stage clinical program with Phase 2B data globally coming
in the fourth quarter of 2013.
First let's talk about our novel oncology delivery platform. It can
be used with a variety of oncology compounds. It most importantly
concentrates drug release at the tumor, and it provides partnership
opportunities for anticancer agents that are losing patent
protection. We are a late stage technology validating pipeline
company. Our lead program is a drug called Aldoxorubicin. It's in a
Phase 3 with a special protocol assessment to start in the first
quarter of next year. We're gearing up for that. We also will have
Phase 2B top line progression-free survival results, and they're
expected in December 2013.
And we have two Phase 2 clinical trials starting this quarter. One in
glioblastoma multiforme, more easily referred to as brain cancer, and
the other one an HIV-related Kaposi's sarcoma.
What's great about CytRx is we have a risk-mitigated strategy, and
our strategy is to create potential blockbuster oncology therapies
from known chemotherapy payloads reducing both development and
Stuart, let me take you through our pipeline. We have a second line
soft tissue sarcoma pivotal trial under a special protocol assessment
agreement with the FDA beginning in the first quarter of 2014. We
have a first line soft tissue sarcoma trial, a Phase 2B global trial
with top line data coming in the fourth quarter of 2013. We have
glioblastoma multiforme trial beginning this quarter, and a Kaposi's
sarcoma trial also beginning this quarter. Both of them will be Phase
2 trials. And finally we have a pharmacokinetics study going on at
Cedars-Sinai Medical Center. It's a Phase 1 ongoing study, and that
study is wrapping up.
In addition we have preclinical work that we're doing in
delivery-enhanced platinum, another chemotherapeutic, and
delivery-enhanced Topotecan. They're in ovarian cancers, small cell
lung cancer, and colorectal cancer.
And to take you through our technology platform and how it operates,
I'm going to have David Haen, our VP of Business Development and
Investor Relations, explain that so that the listeners will have an
opportunity to understand how powerful our platform is with delivery
of enhanced chemotherapeutics.
Very good. Well, David, let's hear from you then.
Okay. Great. So as Steve mentioned, we have a
technology that allows us to optimize chemotherapy agents as well as
other anticancer agents. And what we do is we put a linker onto the
molecule and we're starting with well known cancer agents that have
decades of experience of use in most cases, so we know which types of
tumors respond to treatment with them. We also have a sense of the
safety and what we should be looking for for side effects. And then
with our linker, what we're able to do is infuse the equivalent of 2
1/2 to four times the standard amount of that drug. And really the
lead program Aldoxorubicin, besides being a very broad acting drug in
and of itself, it's really proving the principle of this platform. So
once we have our molecule and it's infused into the patient, it binds
to a protein that's already in the bloodstream. That protein helps
transport it to the tumor, and it's taken into the tumor, and then
due to the environment within that cancer cell, you get release of
our linker, and now we've preferentially released the drug at the
tumor site. And we're not seeing nearly the systemic toxicities that
one typically thinks of when you hear of chemotherapy and someone
being diagnosed with cancer. I think everyone's first thought is I'm
in for some rough treatment, and that is the case, but here we think
we have a way to optimize it. Aldoxorubicin is really the proof of
principle, and the goal is to work with our collaborators in
Freiburg, Germany and continue to develop additional molecules based
on other chemotherapy payloads.
Well David, thank you so much for that. In our next
section we'd like to learn about the leadership of the company, and
you're our guest today as the Vice President of Business Development
and Investor Relations, let's learn a little bit about your
background before we learn about the rest of the team from Steven. Go
Thank you. I've been with CytRx now since 2003 and
helped get us to where we are today through some of the various
iterations. And I think you know, again the company's in the
strongest place it's been in the time that I've been associated with
the company. Prior to that I did work in an investment banking
advisory firm here in Los Angeles focused primarily in healthcare
companies as well as some other industries as well.
Well, thank you, David. Steven, you're the President
and CEO. Let's learn a little bit more about you, the rest of the
management team, and let's also talk a little bit about the board
that you've assembled there as well. Go ahead, Steven.
Well, you know, first turning to the management
team and the board. We have a very, very experienced management team,
particularly as it relates to developing cancer drugs. Dr. Dan
Levitt, who's our Executive Vice President and Chief Medical Officer,
ran worldwide oncology at Sandoz and U.S. oncology at
Hoffmann-LaRoche, and then he was President of Protein Design Lab's
research and development. So he has developed five cancer drugs, and
one transplant drug, and one kidney drug. He's had seven approvals
already, which is quite amazing. In addition, he's supported by a
clinical and regulatory team that has a great deal of experience
working at big pharma, big biotech, and smaller companies like ours.
We do everything in-house, so we have a Chief Counsel, Benjamin
Levin. We have a CFO, John Caloz. We have an accounting department, a
legal department. We have clinical and regulatory. We have investor
relations, business development, and Human Resources. The only
functions that we outsource are manufacturing. Our main manufacturer
is Baxter Oncology based outside Dusseldorf, Germany. And we also
have preclinical in Freiburg, Germany. And then finally we outsource
the CRO function for clinical trials because we're doing trials
So we're able to manage this company on a worldwide basis with
approximately seventeen employees, and outsource what otherwise
requires probably another 100 employees. So we've got a unique team.
Most of the people have been with us for at least five to ten years.
And the key to any organization not only are the drugs which we
believe we have, but the team that works together to build CytRx into
a major oncology company -- and that we have.
In addition supporting that team is a very blue chip Board of
Directors that's been together for approximately ten years. Our
Chairman of the Board is Dr. Max Link. He was Chairman and CEO of
Sandoz-Novartis. And Dr. Link is on the Board of Alexion. He's
chaired Centerpulse in the past, and a number of other prominent
companies including Protein Design Labs and Human Genome Sciences. He
is a legendary executive in the pharma field, and brings tremendous
experience to the board.
In addition, we have Dr. Joe Rubinfeld who's a cofounder of Amgen and
SuperGen, and previously help build the oncology business at
We have the only Nobel laureate in the history of UCLA in physiology
and medicine, Dr. Louis Ignarro, who won the prize in 1998 for
oncology. And in addition, rounding out the board is Mr. Marvin
Selter, who was a pioneer in employee leasing, and sold his company
to a Goldman-Sachs-backed organization. And Richard Wennekamp, who
was President Ford's assistant in the White House, and then was a
senior banking executive of Bank of America, and represents and has
represented the Ford family since he was with President Ford. That's
Very good. Well, it sounds like a well established
esteem board as well as such a massive management team within your
own house. That's great. One way to streamline and keep those
expenses down, that's for sure.
Well Steven, again thank you for that segment. Let's talk a little
bit now about the achievements for the company so far here in 2013.
Well so far in 2013 we achieved a special
protocol assessment in a negotiation with the FDA granting us the
right to do a global pivotal Phase 3 trial in second line soft tissue
sarcoma. Then in addition, we provided additional information on our
drug Aldoxorubicin, additional clinical data at the large ASCO
conference in June in Chicago. We also announced some compelling
preclinical glioblastoma multiforme data which was announced in July
2013. We had three posters presented at ESMO, the equivalent of ASCO
in Europe, and this week we will announce in addition to our second
quarter earnings release we will announce the results of our poster
at CTOS, the Connective Tissue conference which will be going on in
New York beginning on Thursday.
Well Steven, now let's get your vision for the
company here for the remainder of 2013. We're just about to enter
November, so if you want to touch a little bit about Q1, calendar Q1
in 2014, that's fair game as well. Go ahead, Steven.
So in the fourth quarter of 2013, we're going to
start the Phase 2 brain cancer trial with our drug Aldoxorubicin.
It'll be at three centers. It'll be at LSU center in Louisiana. It'll
be at the John Wayne Cancer Center in Los Angeles. And it'll be at
the City of Hope in Los Angeles.
And in addition we will start our Phase 2 HIV Kaposi's sarcoma trial,
and that'll be at LSU. Finally and most importantly we will have in
the fourth quarter of 2013, probably around mid-December, top line
results. That'll be progression-free survival from our Phase 2B
global trial and first line soft tissue sarcoma.
Well listeners, let's jump into some of the recent
news for the company. The company had a press release out. You want
to use that ticker symbol CYTR. It came out on October 23rd, global
Phase 2 clinical data for CytRx's Aldoxorubicin to be featured at the
connective tissue oncology society's annual meeting. David, give us
your insight into this press release.
Well, the press release was to announce that we are
presenting data from the ongoing Phase 2B clinical trial with
Aldoxorubicin. This is the head-to-head comparison of our drug,
Aldoxorubicin, versus generic Doxorubicin. And the patients we're
treating are first line soft tissue sarcoma patients. We had
previously announced at the end of September a difference in the
response rates between the two arms treated in this study, and at
that time the response rate was 22% of the patients receiving our
drug, Aldoxorubicin, had a partial response whereas those receiving
Doxorubicin 0% had any response at that time.
So the data that's being presented at the CTOS meeting on Thursday,
this will be an update of both the response rates as well as giving a
broader picture of the data from that study, including adverse events
as well as number of cycles completed. So you know, this is leading
up to the real data that Steve mentioned, which is coming in December
which is the progression-free survival which is the primary endpoint
for this trial. All of this will be a way to educate the follower of
the drug as well as potential and existing shareholders on the
activity of the drug in the trial.
Hey David, you mentioned a partial response. For the
listeners that may not be familiar, and including myself, tell us a
little bit. What does that mean?
Great. A partial response is defined as a tumor
shrinkage of greater than 30%. So again, you can have a little bit of
fluctuation from various times when the patient comes in to receive
their treatment, and they get scanned to see you know, how the tumors
are going. Are they shrinking? Are they growing? And as we said, in
the trial we saw a 22% partial response rate with our drug versus 0%
with the comparative drug.
And those were data that the scans had been sent to an independent
review which was blinded so the reviewers there didn't know who was
receiving which drug. So therefore, we think that the data are very
robust and solid data, you know, and eliminating any bias potentially
from the clinical site.
Well David, thank you so much on explaining about
partial response. Now you also mentioned earlier about a reduction in
the side effects, and I know you're presenting on that as well. Why
don't you talk to me a little bit about that reduction of side
effects and any other ancillary benefits that we can talk about here.
Go ahead, David.
Okay. As mentioned earlier, because our drug binds to a
protein in the bloodstream, we're not kind of getting the global side
effects that are traditionally seen with this class of drug. One of
the biggest limitations for Doxorubicin, which is the comparator in
our ongoing trial, and the payload from our conjugate, is that
Doxorubicin has a cumulative dose limit, meaning the patient once
they hit that threshold isn't allowed to get additional drugs because
of cardio toxicity or heart toxicity that can lead to congestive
heart failure, cardiomyopathy, et cetera.
So what we've shown, we're going several-fold above this black box
warning, this traditional limitation for this generic drug called
Doxorubicin. And in the ongoing study we're doing a head-to-head
trial looking at you know, how do the drugs look against each other
after six cycles? But in previous studies and other studies like the
PK trial, we've shown that we can go beyond this traditional
limitation in terms of number of cycles, and we've gone to eight
cycles with soft tissue sarcoma. We have one patient in the PK study
who's now approaching I think fifteen cycles. And in the Phase 2
glioblastoma trial which we're getting ready to start, we will be
able to continue dosing until progression.
Again, this might be able to keep someone's tumor either at bay or
maybe it's slowly shrinking, but it takes some time, and we might be
able to achieve these partial responses and hopefully if the drug is
very powerful, we may even be fortunate to see a complete response in
Well listeners, once again, we are speaking with
CytRx. The company is traded under the ticker symbol CYTR. You can
learn more about the company at their website.
It's Cytrx.com. That's
C Y T R X dot com. If you'd like to reach out to the company
directly, well you can reach out to our guest, David Haen. Again,
Vice President of Business Development, as well as Investor
Relations. He's available at (310) 826-5648, extension 304.
We have been speaking once again to David as well as to the CEO of
the company, and I want to thank you both for coming on. Steven,
thank you so much for your time here at SmallCapVoice.com. As
President and CEO I'm sure you're a welcome voice to your
shareholders, and potential investors as well. Thank you, Steven.
Thank you, Stuart.
And David, thank you so much for your personal time
and insight into this company's exciting story. Sounds like a
game-changer. Really loved hearing from you here today as well.
Alright, for David and Steven, this is Stuart Smith
saying thanks so much for listening.
[End of Audio]
About CytRx Corp.
CytRx Corporation (NASDAQ: CYTR) is a biopharmaceutical research and
development company specializing in oncology. CytRx currently is
focused on the clinical development of aldoxorubicin (formerly known
as INNO-206), its improved version of the widely used
chemotherapeutic agent doxorubicin. CytRx is conducting a global
Phase 2b clinical trial with aldoxorubicin as a treatment for soft
tissue sarcomas, has completed its Phase 1b/2 clinical trial
primarily in the same indication and a Phase 1b study of
aldoxorubicin in combination with doxorubicin in patients with
advanced solid tumors, and has completed a Phase 1b pharmacokinetics
clinical trial in patients with metastatic solid tumors. CytRx plans
to initiate under a special protocol assessment a potential pivotal
Phase 3 global trial with aldoxorubicin as a therapy for patients
with soft tissue sarcomas whose tumors have progressed following
treatment with chemotherapy. CytRx also is initiating Phase 2
clinical trials with aldoxorubicin in patients with late-stage
glioblastoma (brain cancer) and AIDS-related Kaposi's sarcoma. CytRx
plans to expand its pipeline of oncology candidates based on a linker
platform technology that can be utilized with multiple
chemotherapeutic agents and may allow for greater concentration of
drug at tumor sites. CytRx also has rights to two additional drug
candidates, tamibarotene and bafetinib. CytRx 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 additional information, please visit the Company's corporate
This press release may contain "forward-looking statements."
Expressions of future goals and similar expressions reflecting
something other than historical fact are intended to identify
forward-looking statements, but are not the exclusive means of
identifying such statements. These forward-looking statements may
include, without limitation, statements about our market opportunity,
strategies, competition, expected activities and expenditures as we
pursue our business plan. Although we believe that the expectations
reflected in any forward-looking statements are reasonable, we cannot
predict the effect that market conditions, customer acceptance of
products, regulatory issues, competitive factors, or other business
circumstances and factors described in our filings with the
Securities and Exchange Commission may have on our results. The
company undertakes no obligation to revise or update any
forward-looking statements in order to reflect events or
circumstances that may arise after the date of this press release.
Los Angeles, Calif.
Mission Investor Relations
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