CytRx Corporation CYTR, a biopharmaceutical research and development
company specializing in oncology, announced the issuance of its annual Letter
to Stockholders from President and CEO Steven A. Kriegsman. The Letter
provides an overview of the Company's business plan and is available on the
Company's website at www.cytrx.com. Excerpts from the Letter are as follows:
To Our Valued Stockholders and Friends:
The coming year promises to be highly eventful as we look forward to reporting
data from three clinical trials and prepare to initiate our first-ever
international pivotal Phase 3 trial for soft tissue sarcomas with our novel
cancer therapy aldoxorubicin. We reached these important inflection points in
just a few years after transitioning our business focus to oncology drug
development and are now significantly closer to our goal of commercializing
innovative, effective treatments for people with cancer.
Cancer is a worldwide issue of epidemic proportions. There is no question of
the need for new drugs that expand the choice of treatments for patients with
cancer and ultimately improve lives. We have the potential to create a robust
pipeline of drug candidates addressing numerous cancers. Aldoxorubicin, our
dramatically improved version of the widely used chemotherapeutic agent
doxorubicin, is its own pipeline, having shown to be superior to doxorubicin
in an array of animal models of cancer. This is just the first drug candidate
we are developing based on a novel linker technology that has the proven
ability to allow attachment of multiple chemotherapeutic agents and is
designed to mitigate the toxicity that limits these agents' use.
In April 2013 we announced that we reached agreement with the U.S. Food and
Drug Administration (FDA) to conduct our first Phase 3 trial with
aldoxorubicin under a special protocol assessment (SPA). The international,
randomized, open-label pivotal Phase 3 clinical trial will enroll
approximately 400 patients with metastatic, locally advanced or unresectable
soft tissue sarcomas who have either not responded to or have progressed
following treatment with one or more systemic regimens of chemotherapies. The
ability to conduct the clinical trial under an SPA could save significant time
compared with a standard regulatory pathway.
We expect to report data from three clinical trials with aldoxorubicin this
year, as follows:
* Aldoxorubicin and Doxorubicin Comparator Clinical Trial: Highly
anticipated progression-free survival data from our international Phase 2b
clinical trial directly comparing aldoxorubicin and doxorubicin as a
first-line treatment for advanced soft tissue sarcoma are expected in the
second half of this year.
* Aldoxorubicin and Doxorubicin Combination Trial: We expect in the second
half of this year to report data from a single-center Phase 1b clinical
trial in 24 patients with advanced solid tumors who have failed other
therapies. Doxorubicin in this trial is being administered at 50% of its
maximum tolerated dose in combination with escalating doses of
aldoxorubicin to determine the maximum tolerated dose of the drug
combination and evaluate preliminary efficacy in this patient population.
* Pharmacokinetics of Aldoxorubicin: Data from our open-label, single-center
Phase 1b clinical trial in patients with metastatic solid tumors are
expected to be reported in the second quarter of this year. These trial
results are expected to form an important component of aldoxorubicin's
development for future regulatory submissions, as well as play a role in
partnership discussions.
We are evaluating the linker technology with a platinum-based chemotherapeutic
agent in preclinical testing. Platinum agents are the most widely used
chemotherapeutic drug class, and are used to treat colorectal, lung, ovarian,
testicular, bladder, and head and neck cancers. We also are investigating a
combination of the linker with lactosaminated albumin (LSA). This combination
has shown the ability in preclinical testing to target and destroy tumors in
the liver. The liver is the second most common site of metastases with 1.8
million cases reported each year worldwide.
I am proud of our team and our many achievements that have brought CytRx to
this transitional time, and am highly enthusiastic about the prospects for our
drugs and our future. We are firmly focused on enhancing shareholder value and
creating a better and healthier world. Thank you for your continued support.
Very truly yours,
Steven A. Kriegsman
President and Chief Executive Officer
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