|CytRx Receives Recommendation for Aldoxorubicin; Celgene's Apremilast Achieves Statistical Significant for Primary, Major Secondary Endpoints|
|By Staff and Wire Reports|
|Monday, 06 May 2013 19:32|
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announced the independent Data Safety Monitoring Committee (DSMC) overseeing the Company's international Phase 2b clinical trial with aldoxorubicin as a first-line treatment for patients with late-stage metastatic soft tissue sarcoma has recommended conducting the clinical trial through completion. This Phase 2b trial allows for a head-to-head clinical comparison of the commonly used chemotherapeutic agent doxorubicin with aldoxorubicin, CytRx's tumor-targeting doxorubicin conjugate. Doxorubicin is dose-limited at a level below its maximum anti-tumor capabilities due to toxicity, including cardiotoxicity. Data from the Phase 2b trial is expected in the second half of 2013.
“The recommendation to complete the Phase 2b trial indicates that the DSMC found no significant safety issues with aldoxorubicin, even though the dose of aldoxorubicin administered in this trial delivers doxorubicin at three-and-a-half times its standard dose,” said CytRx CEO Steven A. Kriegsman. “The DSMC was not charged with evaluating efficacy at this point in the study. Aldoxorubicin combines doxorubicin with our proprietary linker technology. This platform technology includes a single molecule that, when attached to a chemotherapeutic agent, allows for concentration of the agent at the tumor site, thus allowing for greater drug infusion into the tumor. We believe that safely concentrating more drug at the tumor site could improve the drug's effectiveness.
“Aldoxorubicin is the first drug we are evaluating in the clinic based on the linker technology. Doxorubicin was selected for evaluation as it is well-known and has been used by the medical community for decades; however the linker has broad potential utility with proven affinity to couple with multiple chemotherapeutic agents including paclitaxel, docetaxel, cisplatin, irinotecan and methotrexate. Each of these agents may be incorporated into our future clinical development plans,” he added.
The Phase 2b trial is enrolling a total of 105 patients with metastatic, locally advanced or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy and are ineligible for surgery. Patients in the trial are randomized into two groups, with twice as many receiving aldoxorubicin as doxorubicin. The trial's primary objective is to compare progression-free survival between each group. Secondary endpoints include evaluating tumor response and overall patient survival, and assessing the safety of aldoxorubicin compared with doxorubicin in this patient population through a number of indicators, including the frequency and severity of adverse events. Patients are being enrolled in clinical sites in the U.S., Hungary, Romania, Russia, Ukraine, India and Australia.
CytRx holds exclusive worldwide rights to aldoxorubicin, as well as option rights to the protein-binding platform technology that serves as the linker with doxorubicin.
Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) announced statistical significance was achieved for the primary endpoint of ACR 20 at week 16 for patients receiving apremilast 20 mg and 30 mg BID monotherapy in PALACE 4. PALACE 4 is the fourth randomized, placebo-controlled study evaluating the Company's novel, oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with psoriatic arthritis. This is the first Company-sponsored trial studying patients who had not previously received an oral disease-modifying antirheumatic drug (DMARD).
“Despite recent advances in the treatment of psoriatic arthritis, there remains a significant need for more oral DMARD treatment options for DMARD-naïve patients,” said Randall Stevens, VP of Clinical Research and Development for Inflammation & Immunology. “PALACE-4 is now the fourth major randomized apremilast Phase III study to provide promising results for patients with psoriatic arthritis.”
Patients on apremilast also achieved a statistically significant benefit over placebo in key secondary endpoints, as demonstrated in various measures of physical function and signs and symptoms, including enthesitis.
No new safety and tolerability signals identified, with fewer AEs and SAEs reported than in PALACE 1, 2&3. Importantly, in PALACE 4, no systemic opportunistic infections (including TB) or lymphoma were observed through week 24, and there was no increase in risk of cardiovascular events. The most common AEs in PALACE 4 (≥5%) were nausea, diarrhea and headache.
The PALACE 4 study is ongoing and the study extension remains blinded until all patients complete week 52. Full data from this phase III study will be submitted for presentation at appropriate medical meetings.
Results from PALACE 1, one of three registrational randomized, placebo-controlled phase III studies of apremilast in PsA were released at ACR in November 2012. Top-line positive results from the two additional registrational studies of apremilast in PsA (PALACE 2 and PALACE 3) were released in September 2012. Twenty-four-week topline results of PALACE 3 and 52-week results from PALACE 1 will be presented at EULAR in June 2013. Taken together, the PALACE program is the most comprehensive set of psoriatic arthritis studies to date intended for regulatory submission. Results from the PSA-001 phase II study of apremilast in psoriatic arthritis were recently published online in the journal Arthritis & Rheumatism
In addition, positive results from two large, pivotal global studies of apremilast in more than 1,200 patients with moderate-to-severe plaque psoriasis (ESTEEM 1 and 2) were released in January 2013, with full results from ESTEEM 1 presented at AAD in March. Results from PSOR-005, a phase IIb dose-range study of apremilast in psoriasis, were recently published in The Lancet
A randomized, placebo-controlled phase III study (POSTURE) of apremilast in ankylosing spondylitis (AS) began enrolling patients in April 2012. AS, a debilitating disease, which may cause fusion of the spine, arthritis, inflammation of the eye and damage to the heart and affects approximately 2.5 million people in the U.S. and Europe. The trial will randomize approximately 450 patients to receive 20mg or 30mg apremilast, or placebo BID. The primary endpoint is the proportion of patients achieving an ASAS 20 score at week 16.
These results are from an investigational phase III study. Apremilast is not approved for the treatment of psoriatic arthritis.
The NDA/NDS submissions, based on the combined data from PALACE 1, 2 &3 for PsA, were submitted to health authorities in the US and Canada in Q12013 and Q2 2013 respectively. The Company previously announced it expects to file a separate NDA in the US for psoriasis and a combined PsA/psoriasis MAA submission in Europe in the second half of 2013.
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