CytRx is a biopharmaceutical
R&D company particularly focused on the clinical development of
aldoxorubicin, the company’s improved version of widely used chemotherapeutic
agent aldoxorubicin. In a recent article entitled, “Aldoxorubicin: The Drug
CytRx Investors Should Be Watching,” the author describes supporting reasons
aldoxorubicin has the potential to replace doxorubicin, the current standard of
care in cancer treatment, and the value this could provide for shareholders.
Key points in the article,
as discussed by author James Johnson, are:
• Superior efficacy in phase 2b trial
• Addressable Market for aldoxorubicin in STS
• Aldoxorubicin’s capability to treat GBM
• Opportunity for aldoxorubicin in treating other medical
conditions
To read the full article
visit:
http://www.fool.com/investing/general/2014/02/09/aldoxorubicin-the-drug-cytrx-investors-should-be-w.aspx
CytRx recently received FDA
approval to extend the dosing in a phase 3 clinical trial to evaluate
aldoxorubicin as a second-line treatment for soft-tissue sarcomas (STS). The
extended dosing could allow CytRx to demonstrate even higher progression-free
survival (PFS) efficacy results compared to the phase 2b trial for advanced STS
with this drug. The company plans to initiate the phase 3 trial in the first
quarter of 2014.
In December 2013, CytRx
reported highly statistically significant phase 2b trial results, per
investigator assessment and central lab review. In this study, aldoxorubicin
demonstrated 80-100 percent superiority over doxorubicin in regards to PFS.
Additional phase 2b trial data determined ratios for the primary endpoint of
PFS, an important measure of the reliability and uniformity of the PFS data.
Approximately 40,000 new
cases of STS are diagnosed annually, resulting in nearly 13,000 deaths in the
United States and Europe. This provides aldoxorubicin with tremendous growth
potential as a first or second-line treatment for this disease. CytRx expects
to report the results of the second-line treatment study for STS by mid-2016.
The company anticipates filing the New Drug Application with the FDA by the end
of that year.
In January 2014, CytRx
commenced a phase 2 trial to evaluate aldoxorubicin for the treatment of
unresectable glioblastoma multiforme (GBM), a deadly form of brain cancer.
Multiple preclinical studies demonstrated aldoxorubicin’s capability in
limiting GBM tumor cell growth in the brain without affecting healthy brain
tissue. The preliminary results from this trial phase are expected during the
third quarter of 2014.
“Positive results from the
Phase 2 trial will support CytRx in pursuing the rapid development of aldoxorubicin
for unresectable GBM,” writes Johnson. “This will also allow the company to
file for the “breakthrough therapy” designation with the FDA, which is expected
to expedite aldoxorubicin’s marketing approval. This will enable CytRx to
enhance its presence in the oncology drug market to treat GBM, and strengthen
its financial position. The approval of aldoxorubicin for GBM could generate
revenue of roughly $300 million during its peak sales period.”
CytRx also recently
initiated a phase 2 clinical trial for the treatment of HIV-infected patients
suffering from Kaposi’s sarcoma (KS), a common HIV-related tumor. In this
study, CytRx will evaluate the preliminary efficacy and safety of aldoxorubicin
in treating this indication. If positive results are achieved, the company
plans to discuss with the FDA the necessary requirements to file an NDA for
Kaposi’s sarcoma. The phase 2 results are expected during the second quarter of
2015.
Johnson writes in
conclusion, “Aldoxorubicin, with its superior efficacy and safety profile,
could be the blockbuster drug for CytRx. It will generate higher growth
opportunities for CytRx and allow the company to deepen its footprint in the
oncology space. In light of this, several analysts raised their price target on
CytRx shares. The most recent upgrade came from Aegis, which raised their
target from $9 to $12. … Further, the positive results of aldoxorubicin in
future studies will significantly increase shareholder confidence and boost the
company’s valuation.”
For more information, visit
www.cytrx.com
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