CytRx Corp. (CYTR) Massive Potential of Aldoxorubicin in Multiple Soft Tissue Sarcomas Clear from Recent Clinical Data

CytRx has really been turning heads on the street since the company’s lead indication, Aldoxorubicin, a tumor-targeted doxorubicin (an established anthracycline commonly used to treat cancer) conjugate that utilizes a novel acid-sensitive linker molecule to greatly improve overall efficacy and tolerability, returned positive top-line results from a key, global Phase 2b (multicenter, open-label and randomized) clinical trial in soft tissue sarcomas (STS) in the middle of last month (Dec 11).

The added functionality of aldoxorubicin from the linker agent allows for selective binding to albumin in the blood, increasing the chemotherapeutic impact of doxorubicin by as much as four times and simultaneously allowing for a higher dosage that would never be possible with doxorubicin alone due to its toxicity. This statistically significant result for aldoxorubicin versus doxorubicin in a first-line clinical trial, showing incredible numbers like a 63% reduction of disease progression in the investigator review and a 41% reduction in the much more exacting central lab review, has accelerated CYTR’s performance, as well as investor awareness. With the progression-free survival primary endpoints showing extremely low hazard ratios, CYTR is now emboldened by the 95% confidence interval achieved for CT scans read by the investigator and central lab alike, ready to go into the next Phase of trails with renewed vigor.

With these new statistically significant analyses to follow up such superb results released just days ago, the global Phase 2b clinical trial of aldoxorubicin in metastatic, locally advanced or unresectable (non-addressable via surgery) soft tissue sarcomas is looking even better to markets than before. The Kaplan-Meier (per-patient tumor progression interval mapping) curves generated from the trial data further underscore boldly the advantages of aldoxorubicin over doxorubicin and CYTR will be enthusiastically presenting the Kaplan-Meier analysis at the upcoming 50th Annual American Society for Clinical Oncology Meeting, a major industry event which brings together over 25k of the top people in the oncology field. The secondary endpoint data on overall survival should emerge sometime in the third quarter this year and markets have already reacted sharply to the statistically-significant differentiation made possible by this study, clearly excited over the long-term commercial potential of aldoxorubicin across multiple cancer types, especially considering how it overcomes the toxicity concerns that limit large doses of doxorubicin.

This latest burst of data has compelled securities analysts like NY-based full service broker-dealer Aegis Capital to double-down on their buy rating, with an upwardly revised 12-month price target of $9.00 (the Jan 9 close of CYTR was $6.78). An even more bullish buy rating from corporate finance and strategy-focused investment bank, H. C. Wainwright & Co., which has set a $10.00 price target, just adds more fuel to the fire here. Wainwright is assuming that the planned FDA Special Protocol Assessment-enabled Phase 3 work pans out, resulting in a commercial launch of aldoxorubicin in the U.S. and EU in 2017 (peak market penetration by 2022 assumed to be around 28% in second-line and 20% in first-line STS). Wainwright is pegging success for aldoxorubicin at 80% and Aegis bumped their success probability up from 80% to 90%; figures which come into even sharper focus when one considers the American Cancer Society data that indicates some 40k new cases and 13k deaths from the over 50 types of STS, in just the U.S. and EU markets alone.

A massive unmet demand exists globally for a safer, more effective solution than the standard of care doxorubicin. Given the severity of demand from particular cancers like glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer, CYTR could really have their hands on a serious contender here, especially if their Phase 2 clinical trial in unresectable GBM goes well. This open-label and multi-center study will look at some 28 anticipated patients every six weeks via MRI scan to validate efficacy and safety, with the patient class being comprised of individuals whose tumors have progressed following surgery, radiation and temozolomide (the standard oral chemotherapy drug for brain cancer). Success for CYTR in GBM would be a real one-two punch considering the recently reinforced Phase 2b results in STS, and the company could see a direct pathway emerge for approval of aldoxorubicin if similarly positive data is generated for GBM and then coupled with even a single positive pivotal study.

Drilling a bit further into the most recent Phase 2b data review, median progression-free survival for aldoxorubicin patients in an intent-to-treat analysis was nearly double that of doxorubicin (8.4 versus 4.7 months respectively) as assessed by the investigators, with the blind central lab showing 5.7 versus 2.8 months. Furthermore, percentages of patients for whom the disease had not progressed at the 6-month mark were equally impressive, with 67.1% versus 36.1% in the investigator set and 46.8% versus 23.7% in the central lab set.

Given an unambiguous 80% to 100% improvement in progression-free survival from the investigator and central lab alike, President and CEO of CYTR, Steven Kriegsman, has recently had the chance to speak very proudly of the company’s linker technology and the potential of aldoxorubicin to address widespread unmet demand in a variety of STS and other cancers. The targeted payload capability of this technology is able to deliver doxorubicin directly to the cancer cells and CYTR is even eyeballing a Phase 2 clinical trial in HIV-related Kaposi’s sarcoma, a type of connective tissue cancer associated with AIDS (as well as a Phase 2 trial for advanced ductual adenocarcinomas, the most common form of pancreatic cancer). Because protein-hungry tumors by their very nature concentrate albumin, CYTR’s linker technology could quickly emerge as a leading first-line weapon against a whole host of STS, while reducing toxic side effects dramatically over the current indication. It should be noted that in none of the extant study data was there ever clinically significant impact to heart muscle, even at cumulative doses of 2,000 milligrams per square meter, well in excess of the 500 milligrams per square meter (Phase 2b dosage for Aldoxorubicin was 350 milligrams per square meter) typically considered the threshold for doxorubicin before damage to heart muscle occurs (a well-known side effect).

Get a closer look at CytRx Corp. by visiting their website at www.CytRx.com

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