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CytRx Corporation

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Announce overall survival data from the ongoing Phase 2 glioblastoma trial in the second half of 2016
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Source: press release, 3/11/16. 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 Corporation Doses First Patient in Phase 2 Clinical Trial with Aldoxorubicin for the Treatment of Unresectable Glioblastoma Multiforme (Brain Cancer)
LOS ANGELES--(BUSINESS WIRE)--Jan. 14, 2014-- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that the first patient has been dosed in the Company’s Phase 2 clinical trial with aldoxorubicin for the treatment of unresectable glioblastoma multiforme (GBM), a deadly form of brain cancer. The open-label, multisite trial is designed to investigate the preliminary efficacy and safety of aldoxorubicin in patients whose tumors have progressed following prior treatment with surgery, radiation and temozolomide.

“With the dosing of the first patients we are on schedule with this important Phase 2 GBM trial, and look forward to reporting preliminary results in the second half of this year,” said CytRx President and CEO Steven A. Kriegsman. “Aldoxorubicin has been shown to have the unique ability to cross the blood-brain barrier in animal models of human glioblastoma, potentially creating a new approach to attacking brain tumors. Should the data from this trial be positive, we will pursue the rapid development of aldoxorubicin for unresectable GBM, including filing for ‘breakthrough therapy’ designation with the U.S. Food and Drug Administration, which could expedite marketing approval.”

The primary objective of this Phase 2 trial is to determine progression-free survival (PFS) and overall survival (OS) according to RANO Working Group Criteria. The principal secondary objective is to evaluate the safety of aldoxorubicin in study patients as assessed by the frequency and severity of adverse events. The clinical trial is expected to enroll up to 28 patients randomly assigned equally to receive either 350 mg/m2 (260 mg/m2 doxorubicin equivalent) or 250 mg/m2 (185 mg/m2 doxorubicin equivalent) of aldoxorubicin intravenously on Day 1, and every 21 days thereafter until evidence of tumor progression, unacceptable toxicity or withdrawal of consent. Tumor response will be monitored every 6 weeks by MRI until disease progression occurs. The trial is being conducted at the John Wayne Cancer Center/Sarcoma Oncology Center in Santa Monica, Calif., City of Hope in Duarte, Calif. and the Louisiana State University Health Sciences Center in New Orleans.

This Phase 2 study follows positive confirmatory results reported in 2013 from a preclinical study in which aldoxorubicin demonstrated statistically significant efficacy (p<.0001) in the treatment of rapidly growing human brain (glioblastoma) cancer in the brains of animals. In that study, animals treated with aldoxorubicin had median survival of more than 63 days, compared with approximately 25 days for animals treated with doxorubicin or saline. In addition, because aldoxorubicin uptake was confined to the tumor in the brain rather than normal brain tissue, the principal investigator concluded that aldoxorubicin has the potential to safely shrink glioblastoma tumors, which could dramatically prolong patient survival.
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Source: press release, 1/14/14. http://www.cytrx.com/press_releases

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An Open-Label Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of Aldoxorubicin in Subjects With Unresectable Glioblastoma Whose Tumors Have Progressed Following Prior Treatment With Surgery, Radiation and Temozolomide

Estimated Enrollment: 28
Study Start Date: March 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT02014844?term=aldoxorubicin&rank=2

Compound/DeviceSpecialtyIndicationCompound ClassTarget
Aldoxorubicin (INNO-206) (DOXO-EMCH) GBMOncologyGlioblastoma Multiforme (GBM)Anthracycline 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: II

Event Type: Data: Phase II trial results

Dates: 2016-07-01 - 2016-12-31

Results:

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Aldoxorubicin Continues To Demonstrate Positive Clinical Activity In Phase 2 Glioblastoma Trial
OVERALL SURVIVAL NOT YET REACHED; 57% OF PATIENTS CONTINUE TO BE FOLLOWED
CYTRX PLANS TO DISCUSS PIVOTAL TRIAL DESIGN WITH THE FDA
LOS ANGELES, Nov. 23, 2015 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that it has achieved its target enrollment of 28 patients with unresectable glioblastoma multiforme (GBM), a deadly form of brain cancer, in its Phase 2 trial with aldoxorubicin. To date, aldoxorubicin has shown evidence of tumor shrinkage, and overall survival has not yet been reached. Additionally, an advisory board of neuro-oncologists recently met to review the updated Phase 2 results and concluded that aldoxorubicin should be evaluated in combination with Avastin® in what could potentially be a pivotal trial in patients with late-stage GBM.

"The initial findings strongly indicate that aldoxorubicin has significant anti-tumor activity in patients with GBM," said Morris D. Groves, M.D., Neuro-Oncologist, Texas Oncology-Austin Brain Tumor Center and co-principal investigator of the trial. "Pseudo-progression prevented us from determining the true efficacy of this agent since subjects may have been removed from aldoxorubicin treatment prematurely. Adding Avastin® to aldoxorubicin may increase the uptake of this drug into tumors leading to improved efficacy. "

The open-label, multisite single-arm trial is investigating the preliminary efficacy and safety of aldoxorubicin in patients whose tumors have progressed following prior treatment with surgery, radiation and temozolomide. Patients to date received from 1 to 20 cycles of either 350 mg/m2 (260 mg/m2 doxorubicin equivalents) (n=6) or 250 mg/m2 (185 mg/m2 doxorubicin equivalents) (n=22) of aldoxorubicin intravenously on Day 1, and every 21 days thereafter until discontinuation. Median overall survival (range: 1 to 16+ months) has not yet been reached. Fifty-seven percent (16 of 28) of patients continue to be followed for survival with six patients still receiving aldoxorubicin treatment. Clear evidence of pseudo-progression was demonstrated in the tumor lesions of at least 4 subjects either after surgical debulking or by Dynamic Susceptibility Contrast MRI. Other subjects demonstrated extensive tumor necrosis on pathology with small amounts of residual tumor. Pseudo-progression refers to post-treatment imaging changes in the tumor where the tumor appears larger compared to the pre-treatment baseline images. These changes can be misleading in that the tumor appears to get worse (true progression), when in fact the changes may be the result of tumor destruction and related swelling around the tumor bed.

Aldoxorubicin was well tolerated at both dose levels, with all adverse events consistent with known doxorubicin toxicities. No subject has had a decrease in their cardiac function. At the 250 mg/m2 dose, the most common grade 3 or 4 adverse events included neutropenia, fatigue, thrombocytopenia and mucositis. All adverse events resolved prior to the subsequent dose of aldoxorubicin. Only four patients have had aldoxorubicin-related serious adverse events and all have been resolved successfully.

An Advisory Board of neuro-oncology experts recently reviewed the data from this trial. They concluded that aldoxorubicin clearly demonstrated anti-tumor activity with a favorable safety profile and that a randomized, comparative pivotal trial combining aldoxorubicin with Avastin® compared to Avastin® in patients who have relapsed after initial therapy was warranted.

"By adding Avastin® to a treatment regimen with aldoxorubicin, we may be able to improve upon the activity of the agents in these very needy patients," said Daniel Levitt, M.D., Ph.D., CytRx Executive Vice President and Chief Medical Officer. "We plan to develop a protocol for a comparative potential pivotal trial based on the positive feedback from our advisors. We look forward to discussing the protocol with regulatory agencies, like the FDA, once we have the final data from the Phase 2 trial."

This Phase 2 study follows positive confirmatory results reported in 2013 from a preclinical study in which aldoxorubicin demonstrated statistically significant efficacy (p<.0001) in the treatment of rapidly growing human brain (glioblastoma) cancer in the brains of animals. In that study, animals treated with aldoxorubicin had median survival of more than 63 days, compared with approximately 25 days for animals treated with doxorubicin or saline. In addition, because aldoxorubicin uptake was confined to the tumor in the brain rather than normal brain tissue, the principal investigator concluded that aldoxorubicin has the potential to safely shrink glioblastoma tumors, which could dramatically prolong patient survival.
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Source: press release, 11/23/15. http://www.cytrx.com/press_releases

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CytRx Reports Positive Updated Phase 2 Aldoxorubicin Clinical Trial Results in Glioblastoma Multiforme (Brain Cancer)

Aldoxorubicin Has Now Shown Two Complete Responses, In Addition to Tumor Shrinkage, Prolonged Stable Disease, and Favorable Tolerability in Patients

Addition of Avastin® Following or Combined with Aldoxorubicin Treatment Could Prolong Survival

Investigator Meeting at ASCO to Consider Pivotal Trial of Aldoxorubicin and Avastin®

LOS ANGELES, May 21, 2015 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced positive updated results from its ongoing Phase 2 clinical trial with aldoxorubicin for the treatment of unresectable glioblastoma multiforme (GBM), a deadly form of brain cancer. The open-label, multisite trial is designed to investigate the preliminary efficacy and safety of aldoxorubicin in patients whose tumors have progressed following prior treatment with surgery, radiation and temozolomide.

Study subjects (n=18) have received between 1 and 14 cycles of aldoxorubicin, with 4 subjects continuing to receive aldoxorubicin treatment. Subjects received either 350 mg/m2 (260 mg/m2 doxorubicin equivalent) (n=6) or 250 mg/m2 (185 mg/m2 doxorubicin equivalent) (n=12) of aldoxorubicin intravenously on Day 1, and every 21 days thereafter until discontinuation. Notably, 2 subjects (11%) diagnosed with tumor progression following aldoxorubicin treatment (1 and 5 cycles, respectively) demonstrated no microscopic evidence of tumor tissue, a pathological complete response, when tissue was examined after resection. Fourteen of 18 subjects discontinued aldoxorubicin treatment, although there is a significant possibility that some of the patients experienced pseudo-progression. Pseudo-progression refers to post-treatment imaging changes in the tumor where the tumor appears larger compared to the pre-treatment baseline images. These changes can be misleading in that the tumor appears to get worse (true progression), when in fact the changes may be the result of tumor destruction and related swelling around the tumor bed. Following discontinuation of aldoxorubicin treatment, 10 of 14 subjects received treatment with bevacizumab (Avastin®) for 1 to 14 cycles. Deaths have occurred in only 4 of 18 subjects (22%) to date, with survival duration so far of up to 10 plus months.

Aldoxorubicin was well tolerated at both dose levels with all adverse events consistent with known doxorubicin toxicities, but not cardiotoxity. Grade 3 or 4 adverse events were comprised primarily of neutropenia, anemia and fatigue and occurred mainly in the 350 mg/m2 dose group and were resolved before the next dose. Only two aldoxorubicin-related serious adverse events have occurred in the trial, and both resolved successfully.

"GBM is the most common and aggressive malignant primary brain cancer in humans and carries an extremely poor prognosis for the vast majority of diagnosed patients. Prognosis at recurrence is especially poor," said Morris D. Groves, M.D., Neuro-Oncologist, Texas Oncology-Austin Brain Tumor Center and co-principal investigator of the trial. "Pseudo-progression is commonly seen in CNS malignancies undergoing radiation therapy, and it mimics tumor progression, but it is thought to be a treatment-related reaction that could represent an active, inflammatory response against the tumor. The findings from this trial are early but exciting; the finding of no tumor cells in the resected GBM tumor samples after treatment with aldoxorubicin is worth further investigation. This suggests, somewhat paradoxically, that by binding to albumin, aldoxorubicin may allow doxorubicin to cross the blood:brain barrier and into the malignancy."

"These results suggest the possibility that the administration of Avastin® after treatment with aldoxorubicin could prolong survival in patients with relapsed GBM, and patient follow up is currently ongoing," said Daniel Levitt, M.D., Ph.D., CytRx Executive Vice President and Chief Medical Officer. "At the upcoming 2015 American Society of Clinical Oncology (ASCO) Annual Meeting, we will be convening with the study investigators to discuss the potential for a pivotal trial evaluating aldoxorubicin in combination with Avastin® for the treatment of relapsed GBM, with survival as the primary endpoint. We also look forward to submitting the results from this ongoing Phase 2 clinical trial for presentation at a neuro-oncology-focused medical meeting in 2015."

The primary objective of this Phase 2 trial is to determine progression-free survival (PFS) at 6 months and overall survival (OS) in patients with recurrent glioblastoma multiforme. The principal secondary objective is to evaluate the safety of aldoxorubicin in study patients as assessed by the frequency and severity of adverse events. Only patients who have not received prior treatment with bevacizumab (Avastin®) are eligible to participate in the trial. The clinical trial is expected to enroll up to 28 patients randomly assigned equally to receive either 350 mg/m2 (260 mg/m2 doxorubicin equivalent) or 250 mg/m2 (185 mg/m2 doxorubicin equivalent) of aldoxorubicin intravenously on Day 1, and every 21 days thereafter until evidence of tumor progression, unacceptable toxicity or withdrawal of consent. Tumor response is monitored every 6 weeks by MRI until disease progression occurs. The trial is being conducted at the John Wayne Cancer Center/Sarcoma Oncology Center in Santa Monica, CA, City of Hope in Duarte, CA, the Louisiana State University Health Sciences Center in New Orleans, LA, and Texas Oncology in Austin, TX.

This Phase 2 study follows positive confirmatory results reported in 2013 from a preclinical study in which aldoxorubicin demonstrated statistically significant efficacy (p<.0001) in the treatment of rapidly growing human brain (glioblastoma) cancer in the brains of animals. In that study, animals treated with aldoxorubicin had median survival of more than 63 days, compared with approximately 25 days for animals treated with doxorubicin or saline. In addition, because aldoxorubicin uptake was confined to the tumor in the brain rather than normal brain tissue, the principal investigator concluded that aldoxorubicin has the potential to safely shrink glioblastoma tumors, which could dramatically prolong patient survival.
More
Source: press release, 5/21/15. http://www.cytrx.com/press_releases

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CytRx Announces Positive Interim Phase 2 Aldoxorubicin Results in Glioblastoma Multiforme (Brain Cancer)

Aldoxorubicin Shows a Complete Response, Tumor Shrinkage, Prolonged Stable Disease, and Favorable Tolerability in Patients

Novel Albumin-Binding Drug Candidate Appears to Allow Doxorubicin to Cross the Tumor's Blood-Brain Barrier in Humans

LOS ANGELES, Jan. 6, 2015 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced positive interim results from its ongoing Phase 2 clinical trial with aldoxorubicin for the treatment of unresectable glioblastoma multiforme (GBM), a deadly form of brain cancer. The open-label, multisite trial is designed to investigate the preliminary efficacy and safety of aldoxorubicin in patients whose tumors have progressed following prior treatment with surgery, radiation and temozolomide. Preliminary results in 12 patients show both prolonged stable disease and tumor shrinkage in several patients, including one patient who demonstrated no microscopic evidence of tumor when tissue was examined after resection, representing a complete response. These observations suggest that aldoxorubicin allows doxorubicin to cross the tumor's blood-brain barrier in humans.

"Aldoxorubicin appears to be the first anthracycline to cross the blood-brain barrier in GBM, potentially creating a new approach to attacking brain tumors," said Steven Kriegsman, Chairman, President and CEO of CytRx. "These findings are early but important, and suggest that binding to albumin may play a crucial role in transporting chemotherapies that normally cannot cross the tumor blood-brain barrier into the malignancy. They indicate that aldoxorubicin has the potential to address the unmet therapeutic needs of patients suffering from brain cancer. We currently expect to have more definitive data in the first half of this year, which we intend to submit for possible presentation at ASCO 2015."

The primary objective of this Phase 2 trial is to determine progression-free survival (PFS) at 6 months and overall survival (OS) in patients with recurrent glioblastoma multiforme. The principal secondary objective is to evaluate the safety of aldoxorubicin in study patients as assessed by the frequency and severity of adverse events. Only patients who have not received prior treatment with bevacizumab (Avastin®) are eligible to participate in the trial. The clinical trial is expected to enroll up to 28 patients randomly assigned equally to receive either 350 mg/m2 (260 mg/m2 doxorubicin equivalent) or 250 mg/m2 (185 mg/m2 doxorubicin equivalent) of aldoxorubicin intravenously on Day 1, and every 21 days thereafter until evidence of tumor progression, unacceptable toxicity or withdrawal of consent. Tumor response is monitored every 6 weeks by MRI until disease progression occurs. The trial is being conducted at the John Wayne Cancer Center/Sarcoma Oncology Center in Santa Monica, CA, City of Hope in Duarte, CA, the Louisiana State University Health Sciences Center in New Orleans, LA, and Texas Oncology in Dallas, TX.

This Phase 2 study follows positive confirmatory results reported in 2013 from a preclinical study in which aldoxorubicin demonstrated statistically significant efficacy (p<.0001) in the treatment of rapidly growing human brain (glioblastoma) cancer in the brains of animals. In that study, animals treated with aldoxorubicin had median survival of more than 63 days, compared with approximately 25 days for animals treated with doxorubicin or saline. In addition, because aldoxorubicin uptake was confined to the tumor in the brain rather than normal brain tissue, the principal investigator concluded that aldoxorubicin has the potential to safely shrink glioblastoma tumors, which could dramatically prolong patient survival.
More
Source: press release, 1/06/15. http://www.cytrx.com/press_releases

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