ATLANTA, GA--(Marketwired - Nov 7, 2013) - MissionIR today announces the online availability of its interview with CytRx Corp. (
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 team.
Wrapping up the interview, Kriegsman highlights 2013 achievements and provides insight to recent company news and important upcoming developments.
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 today?
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 regulatory risks.
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 ahead, David.
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 globally.
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 Bristol-Myers.
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 the group.
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. Go ahead.
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 the future.
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.
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About CytRx Corp.
CytRx Corporation (
For additional information, please visit the Company's corporate Website: www.Cytrx.com
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.
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