|Aeterna Zentaris to Discontinue Phase 3 Trial in Multiple Myeloma; ZIOPHARM Initiates Phase 2 Study of Ad-RTS IL-12|
|By Staff and Wire Reports|
|Monday, 11 March 2013 19:27|
Aeterna Zentaris Inc. (NASDAQ: AEZS) announced an independent Data Safety Monitoring Board ("DSMB") has recommended discontinuing the ongoing Phase 3 study comparing the efficacy and safety of perifosine to placebo when combined with bortezomib (Velcade®) and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. Based on the outcome of its pre-planned interim analysis of efficacy and safety, the DSMB recommended that patient enrollment be stopped and the study discontinued. The DSMB reported that it was highly unlikely the study would achieve a significant difference in its primary endpoint, progression free survival; no safety concerns were raised.
Juergen Engel, PhD, Aeterna Zentaris President and CEO stated, "We are obviously disappointed with the outcome of the interim analysis as reported to us by the DSMB, both from a patient and Company perspective. However, we remain focused on other significant opportunities such as our Phase 3 trial in endometrial cancer and Phase 2 trials in breast, prostate and bladder cancer with AEZS-108, our NDA filing for AEZS-130 as an oral diagnostic test for growth hormone deficiency in adults, as well as our earlier-stage oncology compound, AEZS-120."
ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced the initiation of a randomized, open label Phase 2 clinical study of Ad-RTS IL-12 in combination with palifosfamide to treat patients with non-resectable recurrent or metastatic breast cancer.
The two-part, multi-center U.S. study will enroll up to 68 patients with non-resectable, recurrent or metastatic breast cancer who have visible lesions or lesions accessible by injection. The study is designed to assess the safety and efficacy of the drug combination of Ad-RTS IL-12 and palifosfamide. Ad-RTS IL-12 is a targeted and controlled DNA-based therapeutic designed to express interleukin-12 (IL-12), a protein important for an immune response to cancer. Palifosfamide is a potent bi-functional DNA alkylating agent.
Part one of the two-part study will consist of a safety assessment for Ad-RTS IL-12 and palifosfamide, alone or in combination. Part two will consist of an efficacy evaluation of the Ad-RTS IL-12 only arm and the combination arm. The primary endpoint of the study is rate of progression-free survival at 16 weeks. Secondary endpoints include objective response rate, duration of response and evaluation of pharmacodynamic tumor markers.
"Several recent breakthroughs in cancer treatment are based on the hypothesis that the immune system plays a central role in suppressing both cancer's growth and metastasis," said John Nemunaitis, M.D., lead investigator and Executive Medical Director, Mary Crowley Medical Research Center. "For breast cancer, the positive correlation of survival with immune response in the tumor elicited by non-immune treatments has only recently been elucidated, and this understanding hints at the potential for exciting new breakthroughs in this still underserved population. We look forward to participating in this study and to gaining further insight regarding the combined effect of Ad-RTS IL-12, a selectively controlled immunotherapy, and palifosfamide, a potent bi-functional DNA alkylating agent."
Jonathan Lewis, M.D., Ph.D., Chief Executive Officer of ZIOPHARM, added, "This study has exciting potential, both for this difficult-to-treat indication and for our synthetic biology platform, in which Ad-RTS IL-12 is the lead program. Building on preclinical work supporting a synergistic effect between Ad-RTS IL-12 and palifosfamide, and the clinical findings from our ongoing Phase 2 melanoma study, we believe the combination of Ad-RTS IL-12 and palifosfamide has the potential to be quite impactful in breast cancer."
Abattis Bioceuticals Corp. (CNSX: FLU) (OTC: ATTBF), announces that it will not be proceeding with its $600,000 non-brokered private placement as previously announced in its Press Release dated February 12, 2013 as it is canvassing other avenues of financing through strategic relationships to prevent any dilution for its shareholders.
Abbott (NYSE: ABT) today announced positive long-term results for the company's innovative Absorb™ Bioresorbable Vascular Scaffold (BVS).
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that an independent Data Safety Monitoring Board ("DSMB") has recommended discontinuing the ongoing Phase 3 study comparing the efficacy and safety of perifosine to placebo when combined with bortezomib (Velcade®) and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. Based on the outcome of its pre-planned interim analysis of efficacy and safety, the DSMB recommended that patient enrollment be stopped and the study discontinued.
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Micro Imaging Technology, Inc. (OTCQB: MMTC) announced that on March 7th the Travis County Texas District Court granted the Company's motion to dismiss a lawsuit filed by Alpine MIT Partners, LLC (Alpine) in May 2012.
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