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CytRx Announces Initial Results of Phase 3 Trial of Aldoxorubicin in Patients with Second-Line Soft Tissue Sarcoma; Subsequent Analysis to Be Announced Fourth Quarter 2016

- Study Shows Near Doubling of Response and Disease Control Rates -
- Company to Host Conference Call at 5:00 p.m. EDT/2:00 p.m. PDT Today -
LOS ANGELES, July 11, 2016 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced the results of an analysis of its global, randomized, Phase 3 clinical trial of aldoxorubicin compared to investigator's choice therapy in patients with relapsed or refractory soft tissue sarcomas (STS).

In accordance with the FDA-granted special protocol assessment, the current analysis occurred following 191 progression events. Because enrollment was interrupted by a partial clinical hold in November 2014, this analysis did not provide for sufficient follow-up for the nearly two-thirds of patients who entered the Phase 3 study after the hold was resolved and enrollment resumed. This resulted in nearly half of all patients being censored (excluded) from the current progression free survival (PFS) evaluation. CytRx expects to conduct a second analysis, which will include longer patient follow-up and allow for greater maturation of all endpoints. The Company expects to announce the results of this evaluation and hold an end-of-Phase 3 meeting with the Food and Drug Administration (FDA) in the fourth quarter of 2016. The partial clinical hold was related to a single patient enrolled in a compassionate use study, which was subsequently resolved successfully.

For the current evaluation, the study did not show a significant difference between aldoxorubicin and investigator's choice therapy for PFS, with a median of 4.17 months and 4.04 months, respectively, for the study's primary endpoint (hazard ratio: 0.91). However, the most immediate indications of therapeutic activity, objective response rate (ORR) and disease control rate (ORR + stable disease ≥ 4 months), showed a near doubling in the aldoxorubicin arm compared to investigator's choice, including in patients who previously received treatment with doxorubicin. Disease control rate for aldoxorubicin was significantly greater than investigator's choice therapy in the intent-to-treat population (p=0.048) as well as in patients who received prior doxorubicin (p=0.0415). Patients continue to be followed for overall survival (OS), a secondary endpoint of the trial.

"While results from this current analysis are immature, a near doubling of response rates with aldoxorubicin suggests a highly active therapy which may benefit certain patients with soft tissue sarcoma," said Sant Chawla, M.D., F.R.A.C.P., Principal Investigator and the Director of the Sarcoma Oncology Center in Santa Monica, California. "Because enrollment was interrupted by a clinical hold, both PFS and response data need to be analyzed at a future date to account for patients enrolled later in the trial. I look forward to this subsequent analysis providing a more complete understanding of aldoxorubicin's potential in this very challenging disease."

Treatment-related adverse events for aldoxorubicin were consistent with those observed in prior studies. Aldoxorubicin was not associated with clinically significant cardiac, kidney or liver toxicities. The Company plans to present updated results of the study at an upcoming medical meeting.

"The complexity, in terms of tumor diversity and primary location, makes soft tissue sarcoma extremely difficult to treat, especially in the relapsed and refractory setting, resulting in few treatment advances over the last four decades," said Daniel Levitt, M.D., Ph.D., Executive Vice President and Chief Medical Officer of CytRx. "This first-of-its-kind study in STS included a comparator arm with multiple regimens, allowing for treatments to be matched to specific sarcoma subtypes. Despite a requirement for this challenging study design, aldoxorubicin demonstrated markedly greater activity over investigator's choice therapy. That said, the unforeseen clinical hold that interrupted this study impacted the outcome of the current evaluation, underscoring a need for a subsequent analysis."

"In over 550 patients treated to date, aldoxorubicin has demonstrated anti-tumor activity in multiple tumor types and has shown a manageable safety profile," said Steven A. Kriegsman, CytRx's Chairman and CEO. "With approximately $68.2 million in cash and equivalents as of our last 10-Q filing, CytRx is funded through the next Phase 3 STS trial analysis and through a readout of our global Phase 2b trial of aldoxorubicin in small cell lung cancer. We are deeply grateful for the continued support and commitment of the patients, their families, the investigators and clinical support professionals participating in the Phase 3 trial."

Conference Call and Webcast
CytRx management will be hosting a conference call and webcast today beginning at 5:00 p.m. Eastern time/2:00 p.m. Pacific time. To access the conference call, dial 844-776-7849 (U.S. and Canada) or 661-378-9544 (international callers) and enter the conference ID number: 47877672. A webcast will be available in the investor relations section of the company's website, www.cytrx.com. A replay of the call and webcast will begin approximately two hours after the live call has ended. To access the replay, dial 855-859-2056 (U.S. and Canada) or 404-537-3406 (international callers) and enter the conference ID number: 47877672.
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Source: press release, 7/11/16. http://www.cytrx.com/press_releases

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CytRx Global Pivotal Phase 3 Clinical Trial with Aldoxorubicin Achieves 191 Target Events Triggering Statistical Data Analysis
Top-line Progression-Free Survival Data Expected in June 2016

LOS ANGELES, April 4, 2016 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that it has reached the target number of progression events in its pivotal, global phase 3 clinical trial with aldoxorubicin as a treatment for patients with second-line soft tissue sarcomas. In accordance with the statistical analysis plan which is incorporated in the Special Protocol Assessment (SPA) granted by the FDA, 191 events were required to trigger the analysis of the primary endpoint of progression-free survival (PFS). The events were reviewed and verified by an independent, blinded radiology organization contracted by CytRx to analyze all of the scans for the Phase 3 pivotal clinical trial.

"Reaching the number of events is an important milestone for the aldoxorubicin Phase 3 trial," said Daniel Levitt, M.D., Ph.D., CytRx's EVP and Chief Medical Officer. "Now we, along with our contract research organization, are in the process of collecting, verifying and analyzing all of the trial data from the 79 sites around the globe. While this is a large undertaking, we expect to have top-line results at the end of this quarter. We are continuing to actively treat and follow patients who have not progressed and are analyzing data to determine the overall survival and safety."

"Aldoxorubicin represents an important new drug for treating patients with advanced soft tissue sarcomas," commented Sant Chawla, M.D., F.R.A.C.P., Principal Investigator and the Director of the Sarcoma Oncology Center in Santa Monica, California. "The Phase 3 trial design is unique in that it is the first trial in soft tissue sarcoma to compare a single agent to five of the most commonly used treatment options. Like many in the sarcoma community, I eagerly look forward to the top-line results with aldoxorubicin."

CytRx plans to discuss with the FDA initiating a rolling New Drug Application by the end of 2016, subject to the outcome of the Phase 3 pivotal trial. Pursuant to FDA approval, CytRx expects to launch aldoxorubicin in the United States as a treatment for patients with second-line soft tissue sarcoma in the second half of 2017.
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Source: press release, 4/04/16. http://www.cytrx.com/press_releases

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Announce top-line data from the global, pivotal Phase 3 clinical trial of aldoxorubicin as second-line treatment in patients with soft tissue sarcomas in the next quarter ending June 30, 2016. Subject to FDA approval, the Company projects aldoxorubicin's market launch in 2017
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Source: press release, 3/11/16. http://www.cytrx.com/press_releases

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CytRx Announces the Completion of Enrollment in Pivotal Global Phase 3 Trial Ahead of Schedule

Top-line progression-free survival data now expected in the first half of 2016

LOS ANGELES, Dec. 1, 2015 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that it has reached its enrollment target of 400 patients for the company's pivotal global Phase 3 clinical trial of aldoxorubicin in patients with previously treated soft tissue sarcoma (STS). Enrollment was originally estimated to be completed in Q1 2016. The Phase 3 trial is a randomized, comparative trial being conducted under a Special Protocol Assessment from the FDA at 79 sites in the United States, Canada, Israel, Australia, Western & Eastern Europe and Chile.

"It is a true testament to the dedicated work of our clinical team, the enthusiasm of our participating physicians, and the willingness of patients to participate in our study that enrollment in our global pivotal Phase 3 clinical trial was completed ahead of schedule," said Steven A. Kriegsman, Chairman and CEO of CytRx. "We now expect to report the primary endpoint of top-line progression-free survival (PFS) in the first half of 2016, and pre-commercial launch activities are underway."

"As a member of the sarcoma research community, I am very excited to see the overwhelmingly positive response from my colleagues to this pivotal trial," said Sant P. Chawla, M.D., F.R.A.C.P., Principal Investigator and Director of the Sarcoma Oncology Center. This trial is the first to compare a single agent, aldoxorubicin, to five of the most commonly used treatment options for STS patients that have received prior chemotherapy. The rapid timeframe in which this Phase 3 trial reached its targeted enrollment reflects the desire of practitioners for more efficacious therapies."

Trial Design

This is a multicenter, randomized, open-label Phase 3 clinical trial designed to enroll approximately 400 late-stage patients with metastatic, locally advanced or unresectable soft tissue sarcomas who have either not responded to, or who have progressed following treatment with one or more systemic regimens of nonadjuvant chemotherapies. Trial patients are randomized 1:1 to be treated with aldoxorubicin or the investigator's choice of an approved chemotherapeutic regimen, including doxorubicin, ifosfamide, dacarbazine, pazopanib (Votrient®), or gemcitabine plus docetaxel. The primary endpoint of the study is PFS and will be calculated after 191 events occur. Secondary endpoints include overall survival, response rates and safety. In January 2014, CytRx announced that it received approval from the FDA to amend the Phase 3 protocol to continue dosing patients with aldoxorubicin until disease progression as defined by RECIST 1.1 criteria. The ability to dose until disease progression creates the potential for substantially improved Phase 3 efficacy results.
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Source: press release, 12/01/15. http://www.cytrx.com/press_releases

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Complete enrollment in the ongoing pivotal global Phase 3 clinical trial of aldoxorubicin as a second-line treatment for STS by year-end 2015, with PFS data announced in mid-2016. Subject to FDA approval, the Company projects market launch in 2017.
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Source: press release, 3/10/15. http://www.cytrx.com/press_releases

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CytRx Announces FDA's Removal of Partial Clinical Hold for Aldoxorubicin Clinical Trials Permitting Immediate Enrollment of New Patients

Company does not expect estimated timelines to materially change

LOS ANGELES, Jan. 20, 2015 /PRNewswire/ -- CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that the United States Food and Drug Administration (FDA) has removed the partial clinical hold on the Company's aldoxorubicin clinical trials. Enrollment and dosing of new patients is now permitted after study sites' Institutional Review Boards (IRBs) approve the revised trial protocols.

"CytRx developed modified study parameters intended to avoid potential risks, while allowing the company to evaluate the therapeutic impact of aldoxorubicin for patients with soft tissue sarcoma, glioblastoma, Kaposi's sarcoma, and small cell lung cancer, among other trials," said Steven A. Kriegsman, Chairman and CEO of CytRx. "Our staff worked closely with the FDA Oncology Division to resolve all partial clinical hold issues as rapidly as possible. We expect enrollment and dosing in the ongoing clinical trials to be back underway soon."

CytRx currently believes that enrollment rates and timelines for its trials will remain materially unchanged. The Company expects to complete enrollment in its ongoing pivotal global Phase 3 trial in second-line soft tissue sarcoma by the end of 2015 and unblind the clinical data by mid-2016. Subject to FDA approval, CytRx's market launch of aldoxorubicin for second line soft tissue sarcoma is projected to commence in 2017.
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Source: press release, 1/20/15. http://www.cytrx.com/press_releases

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CytRx Receives Written FDA Communication Regarding Partial Clinical Hold for Aldoxorubicin Clinical Trials

Company Continues to Expect Clinical Trial Timelines to Remain Materially Unchanged and Expeditiously Resolved

LOS ANGELES, Dec. 3, 2014 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that the Company has received written notice from the United States Food and Drug Administration (FDA) that its clinical trials for aldoxorubicin have been placed on partial clinical hold. The news supplements and is consistent with the prior verbal communications from the FDA.

As previously announced, all currently enrolled patients can continue receiving aldoxorubicin treatment, or comparator drugs, as per study protocols, but no new patients can be enrolled until the clinical hold is lifted. At the FDA's request, the Company will amend all aldoxorubicin study protocols to include an appropriate inclusion/exclusion criteria, an additional patient screening assessment and an evaluation of serum electrolytes prior to aldoxorubicin administration. CytRx is working diligently in collaboration with the FDA to seek the release of the clinical hold and resume enrollment in its clinical studies.

CytRx currently believes that the partial hold issue will be expeditiously resolved and that enrollment rates and timelines for its ongoing trials will remain materially unchanged, subject to FDA timing. The Company currently expects to announce preliminary results from the ongoing Phase 2 clinical trial of aldoxorubicin in Kaposi's Sarcoma in the first half of 2015 and preliminary results from the ongoing Phase 2 clinical trial of aldoxorubicin in glioblastoma multiforme in the first half of 2015. CytRx remains committed to completing enrollment of its ongoing pivotal global Phase 3 trial in second-line soft tissue sarcoma by the end of 2015.
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Source: press release, 12/03/14. http://www.cytrx.com/press_releases

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CytRx Announces Partial Clinical Hold Affecting Aldoxorubicin Clinical Trials

All Currently Enrolled Patients Can Continue Receiving Aldoxorubicin Therapy or Comparator Drugs; One Inclusion/Exclusion Criteria to be Amended for New Trial Patients to Add Additional Safety Measure

Company Expects Trial Timelines to Remain Materially Unchanged

LOS ANGELES, Nov. 18, 2014 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that the Company has received notice from the United States Food and Drug Administration (FDA) that its clinical trials for aldoxorubicin have been placed on partial clinical hold. All currently enrolled patients can continue receiving aldoxorubicin treatment, or comparator drugs, as per study protocols, but no new patients can be enrolled until the clinical hold is lifted.

The FDA has indicated that the partial clinical hold is due to the reported death of a patient with advanced-stage cancer who did not qualify to participate in any of the ongoing aldoxorubicin clinical trials, but had received aldoxorubicin under the Company's expanded access ("compassionate use") program. At the FDA's request, the Company will amend all aldoxorubicin study protocols to include an appropriate inclusion/exclusion criteria, an additional patient screening assessment and an evaluation of serum electrolytes prior to aldoxorubicin administration. CytRx is working diligently in collaboration with the FDA to seek the release of the clinical hold and resume enrollment in its clinical studies as expeditiously as possible.

CytRx currently believes that the partial hold issue will be expeditiously resolved and that enrollment rates and timelines for its ongoing trials will remain materially unchanged. The Company currently expects to announce preliminary results from the ongoing Phase 2 clinical trial of aldoxorubicin in Kaposi's Sarcoma in the second quarter of 2015 and preliminary results from the ongoing Phase 2 clinical trial of aldoxorubicin in glioblastoma multiforme in the first half of 2015. CytRx remains committed to completing enrollment of its ongoing pivotal global Phase 3 trial in second-line soft tissue sarcoma by the end of 2015.
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Source: press release, 11/18/14. http://www.cytrx.com/press_releases

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CytRx Initiates Pivotal Global Phase 3 Clinical Trial with Aldoxorubicin for Second-Line Treatment of Soft Tissue Sarcoma
Trial to be Conducted under a Special Protocol Assessment with the FDA

LOS ANGELES--(BUSINESS WIRE)--Mar. 24, 2014-- CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced it has initiated a pivotal global Phase 3 clinical trial to evaluate the efficacy and safety of aldoxorubicin as a second-line treatment for patients with soft tissue sarcoma (STS) under a Special Protocol Assessment with the FDA. Aldoxorubicin combines the chemotherapeutic agent doxorubicin with a novel linker-molecule that binds specifically to albumin in the blood to allow for delivery of higher amounts of doxorubicin (3.5 to 4 times) without several of the major treatment-limiting toxicities seen with administration of doxorubicin alone.

This multicenter, randomized, open-label Phase 3 clinical trial is designed to 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 non-adjuvant chemotherapies. Trial patients will be randomized 1:1 to be treated with aldoxorubicin or the investigator’s choice of an approved chemotherapeutic regimen, including doxorubicin, ifosfamide dacarbazine, pazopanib (Votrient®), or gemcitabine plus docetaxel, with up to three comparator regimens to be selected by the investigator at each clinical site. The primary endpoint of the study is progression-free survival (PFS), and secondary endpoints include overall survival, response rates and safety. In January 2014, the Company announced it has received approval from the FDA to amend the Phase 3 protocol to continue dosing patients with aldoxorubicin until disease progression (defined as an increase in the size of measurable tumors by 20% or the development of a new tumor lesion), which creates the potential for substantially improved Phase 3 efficacy results. The Company expects to complete trial enrollment in 2015.

In a phase 1b/2 study, partial responses were observed in 5 of 13 patients with metastatic soft tissue sarcomas who had progressed following initial chemotherapy. Eight of 13 patients showed evidence of tumor shrinkage; 5 of the 8 patients had received prior doxorubicin chemotherapy and had not demonstrated tumor reduction. Updated analysis of median progression-free survival in patients has reached over 17 months without subsequent treatments.
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Source: press release, 3/24/14. http://www.cytrx.com/press_releases

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CytRx Announces Agreement with FDA on Special Protocol Assessment for Global Pivotal Phase 3 Clinical Trial with Aldoxorubicin for Soft Tissue Sarcoma

SPA provides clear pathway through the regulatory process

Preparations underway to commence enrollment

LOS ANGELES--(BUSINESS WIRE)--Apr. 23, 2013-- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announced today that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under a special protocol assessment (SPA) for a global pivotal Phase 3 trial with aldoxorubicin as a treatment for patients with soft tissue sarcomas who have relapsed or were refractory following prior treatment with chemotherapy. The SPA is a written agreement between the Company, as the trial’s sponsor, and the FDA regarding the design, endpoints and planned statistical analysis approach of the Phase 3 clinical trial to be used in support of a potential New Drug Application (NDA) for aldoxorubicin. The Company is actively making preparations for the pivotal Phase 3 trial.

“By reaching an agreement on an SPA, the FDA deems that results from this single Phase 3 clinical trial will be acceptable to support the regulatory approval of aldoxorubicin as a second-line treatment for patients with soft tissue sarcoma, with final marketing approval dependent on the results of the trial and other accomplishments,” said Steven A. Kriegsman, CytRx President and CEO. “The ability to conduct the clinical trial under an SPA could save significant time compared with a standard regulatory pathway. Our optimism about aldoxorubicin’s prospects in this difficult-to-treat indication is predicated on positive results from a Phase 1b/2 trial in which this novel agent was associated with objective responses and prolonged progression-free survival in several patients with advanced soft tissue sarcoma who had relapsed or not responded to prior treatments, as well as on additional clinical and preclinical data.”
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Source: press release, 4/23/13. http://www.cytrx.com/press_releases

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A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator's Choice in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy
Enrollment: 433
Study Start Date: January 2014
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT02049905?term=Aldoxorubicin&rank=5

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Aldoxorubicin (INNO-206) (DOXO-EMCH) SarcomaOncologySarcomaAnthracycline antibioticDNA

Mechanism of action: Aldoxorubicin (INNO-206) (DOXO-EMCH) is a 6-maleimidocaproyl hydrazone derivative prodrug of the anthracycline antibiotic doxorubicin (DOXO-EMCH) with antineoplastic activity. Following intravenous administration, doxorubicin prodrug INNO-206 binds selectively to the cysteine-34 position of albumin via its maleimide moiety. Doxorubicin is released from the albumin carrier after cleavage of the acid-sensitive hydrazone linker within the acidic environment of tumors and, once located intracellularly, intercalates DNA, inhibits DNA synthesis, and induces apoptosis. Albumin tends to accumulate in solid tumors as a result of high metabolic turnover, rapid angiogenesis, hyervasculature, and impaired lymphatic drainage. Because of passive accumulation within tumors, this agent may improve the therapeutic effects of doxorubicin while minimizing systemic toxicity.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2016-10-01 - 2016-12-31

Results:

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CytRx Reports Statistically Significant Updated Results from Pivotal Phase 3 Trial of Aldoxorubicin in Patients with Second-Line Soft Tissue Sarcomas
- Aldoxorubicin Achieves Primary Endpoint of Statistically Significant Improvement in Progression-Free Survival in Patients with Leiomyosarcoma and Liposarcoma, the Two Most Common Sarcomas -
- Aldoxorubicin Also Achieves Primary Endpoint of Statistically Significant Improvement in Progression-Free Survival in Patients Treated in North America, and Shows a Positive 71% Improvement in Disease Control Rate -
- CytRx Plans to File an NDA with U.S. FDA in 2017 -
- Company to Host Conference Call Tuesday, November 29, 2016 at 8:30 a.m. ET / 5:30 a.m. PT -
LOS ANGELES, Nov. 29, 2016 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR) today announced positive updated results from its pivotal Phase 3 clinical trial evaluating aldoxorubicin compared to investigator's choice in patients with relapsed or refractory soft tissue sarcomas (STS). The study, which enrolled 433 patients, demonstrated a statistically significant improvement in progression-free survival (PFS) between aldoxorubicin and investigator's choice therapy in 246 patients with leiomyosarcoma and liposarcoma, (p=0.007). The hazard ratio (HR) was 0.62 (95% CI 0.44-0.88), representing a 38% reduction in the risk of tumor progression for patients receiving aldoxorubicin versus investigator's choice. Leiomyosarcoma and liposarcoma are the two most common types of STS and accounted for 57% of the patients enrolled in the trial.

Aldoxorubicin demonstrated a statistically significant improvement in PFS over investigator's choice in 312 patients treated in North America (p=0.028; HR=0.71, 95% CI 0.53-0.97). Notably, aldoxorubicin performed better than investigator's choice for the entire study population and narrowly missed statistical significance (p=0.12; HR=0.81, 95% CI 0.64-1.06). All responses were determined by an independent, blinded central lab assessment of scans.

"This data represents a major step forward for STS, a rare, highly complex and very difficult-to-treat group of cancers," commented Sant Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, California, and Principal Investigator for the Phase 3 trial. "These results are important because they demonstrate that treatment with aldoxorubicin can extend the time to progression in a clinically meaningful way. The trial design used was more stringent than any prior clinical trial in STS as it compared aldoxorubicin to real world alternatives. The control arm allowed trial investigators to select any one of the five most widely used treatments best suited for their patients' specific type of STS. Unlike other clinical trials for relapsed or refractory STS which used either dacarbazine or placebo as the control, this study was biased in favor of choosing the best therapy for the patients, a truly unique study design."

CytRx plans to submit the results of this clinical trial for presentation at an upcoming major scientific meeting.

In the entire study population, aldoxorubicin achieved a statistically significant improvement in the disease control rate (DCR; defined as objective response rate (ORR) plus stable disease for at least 4 months) of 29.4% versus 20.5% for the patients treated with investigator's choice (p=0.030). In North American patients, the benefit was even more pronounced with aldoxorubicin-treated patients exhibiting a DCR of 32.9%, compared to 19.2% for patients treated with investigator's choice (p=0.007), an overall improvement of 71%. ORR in North American patients also favored aldoxorubicin over investigator's choice, 8.7% versus 3.3% (p=0.058). Of note, no objective responses were observed in patients treated with Votrient® (pazopanib). Patients continue to be followed for overall survival (OS), a secondary endpoint, and CytRx expects the OS data to be available in 2017.

PFS, DCR and ORR data are summarized in the following table:

Phase 3 Aldoxorubicin Efficacy Results

N
Aldoxorubicin
Investigator's Choice
P Value
All patients with Leiomyosarcoma and Liposarcoma (PFS)

246
HR = 0.62 (95% CI 0.44-0.88)
0.007

North American1 patients (PFS)

312
HR = 0.71 (95% CI 0.53-0.97)
0.028
Disease Control Rate (DCR)2

32.9%
19.2%
0.007
Objective Response Rate (ORR)

8.7%
3.3%
0.058
All patients (PFS)

433
HR = 0.81 (95% CI 0.64-1.06)
0.120
Disease Control Rate (DCR)2

29.4%
20.5%
0.030

1Per trial statistical analysis plan, North America is defined as United States, Canada and Australia and comprises 72% of total trial patients
2DCR=ORR + stable disease for ≥4 months
Pre-specified analyses were based on sarcoma histopathology and geography. The geographic analysis includes patients from North America (defined as the United States, Canada and Australia, per the trial statistical analysis plan). The 312 patients treated in North America comprise 72% of the total trial population, including 296 patients from the United States, 8 patients from Canada and 8 patients from Australia. The 246 patients with leiomyosarcoma or liposarcoma comprise 57% of the total trial population.

Aldoxorubicin did not cause clinically significant cardiac, renal, or hepatic toxicities. For the global trial population, the most commonly reported adverse events were neutropenia and anemia consistent with prior clinical trials with aldoxorubicin. Grade 3 or higher hypertension occurred in patients receiving Votrient® (pazopanib). Grade 3 or higher adverse events were manageable with supportive care and occurred at a rate of 61% for patients receiving aldoxorubicin and 46% in patients treated with investigator's choice. Importantly, treatment-emergent adverse events leading to discontinuation occurred in 4.2% of patients treated with aldoxorubicin, compared to 6.3% for patients receiving investigator's choice. Serious adverse events, primarily febrile neutropenia that resolved and rarely led to treatment termination occurred more frequently in patients administered aldoxorubicin. Treatment-related deaths occurred in one aldoxorubicin-treated patient and in no patients receiving investigators' choice drugs.

Based on these results, CytRx expects to submit a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for aldoxorubicin as a treatment for patients with relapsed or refractory STS in 2017.

"These results show that globally leiomyosarcoma and liposarcoma patients treated with aldoxorubicin exhibited significantly longer PFS than patients treated with both FDA-approved and commonly used therapies in the second-line setting," said Daniel Levitt, M.D., Ph.D., EVP and Chief Medical Officer of CytRx. "We are also very encouraged by the statistically significant improvements observed in North American STS patients treated with aldoxorubicin who exhibited both longer PFS and superior response rates."

"We are deeply grateful for the support and commitment of the sarcoma investigators, along with the patients and families who took part in or contributed to this Phase 3 trial," stated Steven A. Kriegsman, CytRx's Chairman and Chief Executive Officer. "We look forward to sharing the data from these key patient populations with the FDA to support an NDA for aldoxorubicin as a second-line treatment for patients suffering with soft tissue sarcomas."

Conference Call and Webcast

CytRx management will be hosting a conference call and webcast today beginning at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time to discuss the results of the Phase 3 trial. To access the conference call, dial 844-358-6753 (U.S. and Canada) or 216-562-0397 (international callers) and enter the conference ID number: 27115631. A webcast will be available in the investor relations section of the company's website, www.cytrx.com. A replay of the call and webcast will begin approximately two hours after the live call has ended. To access the replay, dial 855-859-2056 (U.S. and Canada) or 404-537-3406 (international callers) and enter the conference ID number: 27115631.
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Source: press release, 11/29/16. http://www.cytrx.com/press_releases

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