CytRx Corporation's (NASDAQ: CYTR ) oncology drug, aldoxorubicin, an improved version of the chemotherapeutic agent doxorubicin, recently received FDA approval to extend the dosing in a Phase 3 clinical trial. This trial is evaluating aldoxorubicin as a second-line treatment for soft-tissue sarcomas (STS). In April 2013, the FDA granted Special Protocol Assessment (SPA) to aldoxorubicin as a second-line treatment for STS with a maximum dosing of six cycles. The drug is given by a 30 minute IV infusion once every three weeks which is one cycle. The extension of the treatment cycle was based on aldoxorubicin's superior cardiac safety and efficacy profile compared to doxorubicin in prior studies. Aldoxorubicin was found to be safer than doxorubicin, a toxic drug associated with side effects such as cardiovascular events and heart damage in cancer patients. 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 during the first quarter of 2014.
Superior efficacy in phase 2b trial
In December 2013, CytRx reported Phase 2b trial results, which evaluated the efficacy and safety profile of aldoxorubicin compared to doxorubicin as a first-line treatment of metastatic and unresectable STS. Under the investigator assessment and central laboratory review, Aldoxorubicin demonstrated 80%-100% superiority over doxorubicin in regards to PFS.
The Phase 2b trial results were highly statistically significant. Aldoxorubicin demonstrated superiority in both the investigator led assessments as well as the blinded central lab review. The investigator led assessment determined that the PFS for aldoxorubicin patients was 8.4 months compared to just 4.7 months for those treated with doxorubicin. The central lab review determined that the PFS for aldoxorubicin patients was 5.7 months compared to just 2.8 months for doxorubicin patients.
On January 8, CytRx reported additional results of this Phase 2b trial. The additional data determined hazard ratios for the primary endpoint of PFS, which is considered as an important measure regarding the reliability and uniformity of the PFS data. CytRx's aldoxorubicin also provided superior results in a Kaplan-Meier analysis. These superior results are expected to support CytRx's quest to receive FDA approval.
Addressable Market for aldoxorubicin in STS
Aldoxorubicin has significant growth potential as a first- or second-line treatment to treat STS. There are approximately 50 types of STS, and roughly 40,000 new cases are diagnosed annually resulting in nearly 13,000 deaths in the U.S. and Europe. The results of the second-line treatment study for STS are expected by mid-2016, and the company anticipates filing the NDA by the end of that year.
The success of aldoxorubicin for treating STS could generate peak sales of around $340 million during its patent life as a second-line treatment. Further, aldoxorubicin is the first and only single agent that surpassed doxorubicin as a first-li! ne treatment for STS. This will provide greater opportunities if aldoxorubicin is approved as a first-line treatment for STS.
Aldoxorubicin's capability to treat GBM
On January 14, CytRx initiated a Phase 2 trial to evaluate aldoxorubicin for the treatment of unresectable glioblastoma multiforme (GBM), a deadly form of brain cancer. It is a stage 4 brain tumor, which affects more than 12,500 U.S. residents annually. In September 2013, CytRx received approval from the FDA for initiating this Phase 2 trial. In the multiple preclinical studies, aldoxorubicin was found capable of 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 this year.
Positive results from the Phase 2 trial will support CytRx in pursuing the rapid development of aldoxorubicin for unresectable GBM. 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.
Opportunity for aldoxorubicin in treating other medical conditions
CytRx 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. CytRx will evaluate the preliminary efficacy and safety of aldoxorubicin in treating this indication. Currently, the standard-of-care drug for KS is liposomal doxorubicin-"Doxil." If the results are positive, CytRx plans to discuss with the FDA what they would require to file an NDA for Kaposi's sarcoma. The phase 2 results are expected during the second quarter of 2015.
If aldoxorubicin is successful in treating Kaposi's sarcoma, then it could capture market sha! re from J! anssen, a subsidiary of Johnson & Johnson (NYSE: JNJ ) , and , Sun Pharmaceutical, which is manufacturing the FDA-approved generic version of Doxil. Sun Pharmaceutical has a 50% market share of generic Doxil in the U.S. Furthermore, aldoxorubicin has opportunities in treating multiple indications, which include breast, ovarian, small-cell lung, multiple melanoma, and acute myelocytic leukemia. This will further strengthen its position in the oncology sector.
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.
Since 2010, CytRx has built a state-of-the-art research and development program. CytRx's focus on R&D to develop aldoxorubicin will help enhance the company's future growth prospects. Further, the positive results of aldoxorubicin in future studies will significantly increase shareholder confidence and boost the company's valuation.
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