Restructuring to Place Exclusive Strategic Focus on Synthetic Biology Programs
NEW YORK, NY, USA I March 26, 2013 I ZIOPHARM Oncology, Inc. (ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced today that its Phase 3 trial of palifosfamide (ZIO-201) for the treatment of metastatic soft tissue sarcoma in the first-line setting (PICASSO 3) did not meet its primary endpoint of progression-free survival (PFS). The study’s independent data monitoring committee (IDMC) has recommended that patients be followed for overall survival (OS), the study’s secondary endpoint, however the Company does not expect to continue follow up for OS. Palifosfamide was well tolerated, with a safety profile in combination with doxorubicin observed in the study comparable with other palifosfamide clinical trials in soft tissue sarcoma. Full data from PICASSO 3 will be submitted for publication in a scientific journal.
With this outcome, ZIOPHARM has made the decision to immediately place exclusive strategic focus on its synthetic biology programs, which are being developed in partnership with Intrexon Corporation. The lead therapeutic candidate in this program is Ad-RTS IL-12, a DNA therapeutic to enable controlled delivery of therapeutic interleukin-12 (IL-12), a protein important for an immune response to cancer. This is achieved by placing IL-12 under the control of Intrexon’s proprietary biological "switch" (the RheoSwitch Therapeutic System(R), RTS(R)) to turn on/off the therapeutic protein expression. Ad-RTS IL-12 is currently being tested in two Phase 2 studies, the first for the treatment of advanced melanoma, and the second in combination with palifosfamide for the treatment of non-resectable recurrent or metastatic breast cancer.
A highly focused team within the Company will be deployed in support of these programs. As a result, a restructuring plan is immediately being put into place to align staffing to current objectives and to marshal its resources toward achieving success with its synthetic biology programs.
"We are disappointed that the PICASSO 3 study did not meet its primary endpoint of progression-free survival," said Jonathan Lewis, M.D., Ph.D., Chief Executive Officer of ZIOPHARM. "We sincerely thank the trial investigators, clinical sites and the ZIOPHARM team for conducting a highly rigorous study, and are deeply appreciative to the cancer patients and their families for their participation in this trial."
Dr. Lewis added: "It is imperative that the Company rapidly focus its resources and efforts on our highly promising synthetic biology programs, employing therapeutic motifs that represent the next-generation in biotechnology."
Conference Call and Webcast March 26, 2013, at 8:30 AM ET
ZIOPHARM will host a conference call and live audio webcast today, March 26, 2013, at 8:30 AM ET to discuss the PICASSO 3 trial. The call can be accessed by dialing (877) 303-9850 (U.S. and Canada) or (408) 427-3732 (international). The passcode for the conference call is ‘ZIOPHARM.’ To access the live audio webcast, or the subsequent archived recording, visit the "Investors – Events & Presentations" section of the ZIOPHARM website at www.ziopharm.com. The webcast will be recorded and available for replay on the Company’s website for two (2) weeks.
About PICASSO 3
The PICASSO 3 trial is an international, randomized, double-blinded, placebo-controlled study. A total of 447 patients with metastatic soft tissue sarcoma were randomized to receive either intravenous palifosfamide plus doxorubicin (150 mg/m2 3 days every 21 days for a maximum of 6 cycles followed by 75 mg/m2 1 day every 21 days for a maximum of 6 cycles) or doxorubicin alone (75 mg/m2 1 day every 21 days for a maximum of 6 cycles). The primary endpoint for the study is improvement in PFS, with overall survival as a key secondary endpoint. Other secondary endpoints include quality of life assessments, and the safety and tolerability of this combination in this patient population. PICASSO 3 was conducted at more than 150 clinical centers in North America, Europe, South America, Australia, Israel and Asia.
About ZIOPHARM Oncology, Inc.:
ZIOPHARM Oncology is a biopharmaceutical company focused on the development and commercialization of new cancer therapies. The Company’s clinical programs include:
Ad-RTS IL-12 is currently being tested in two Phase 2 studies, the first for the treatment of advanced melanoma, and the second in combination with palifosfamide for the treatment of non-resectable recurrent or metastatic breast cancer. Ad-RTS IL-12 uses synthetic biology to enable controlled delivery of therapeutic interleukin-12 (IL-12), a protein important for an immune response to cancer. ZIOPHARM’s DNA synthetic biology platform is being developed in partnership with Intrexon Corporation and employs an inducible gene-delivery system that enables controlled delivery of genes that produce therapeutic proteins to treat cancer. This is achieved by placing IL-12 under the control of Intrexon’s proprietary biological "switch" (the RheoSwitch Therapeutic System(R), RTS(R)) to turn on/off the therapeutic protein expression at the tumor site.
Palifosfamide (ZIO-201) is a potent, bi-functional DNA alkylating agent that has activity in multiple tumors by evading typical resistance pathways. Palifosfamide is in the same class as bendamustine, cyclophosphamide, and ifosfamide.
Indibulin (ZIO-301) is a novel, tubulin binding agent that is expected to have several potential benefits, including oral dosing, application in multi-drug resistant tumors, no neuropathy and a tolerable toxicity profile. It is currently being studied in a Phase 1/2 trial in metastatic breast cancer.
Darinaparsin (ZIO-101) is a novel mitochondrial-and hedgehog-targeted agent (organic arsenic) currently in ongoing studies with Solasia Pharma K.K.
ZIOPHARM’s operations are located in Boston, MA, and New York City. Further information about ZIOPHARM may be found at www.ziopharm.com.
SOURCE: Ziopharm
Post Views: 65
Restructuring to Place Exclusive Strategic Focus on Synthetic Biology Programs
NEW YORK, NY, USA I March 26, 2013 I ZIOPHARM Oncology, Inc. (ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced today that its Phase 3 trial of palifosfamide (ZIO-201) for the treatment of metastatic soft tissue sarcoma in the first-line setting (PICASSO 3) did not meet its primary endpoint of progression-free survival (PFS). The study’s independent data monitoring committee (IDMC) has recommended that patients be followed for overall survival (OS), the study’s secondary endpoint, however the Company does not expect to continue follow up for OS. Palifosfamide was well tolerated, with a safety profile in combination with doxorubicin observed in the study comparable with other palifosfamide clinical trials in soft tissue sarcoma. Full data from PICASSO 3 will be submitted for publication in a scientific journal.
With this outcome, ZIOPHARM has made the decision to immediately place exclusive strategic focus on its synthetic biology programs, which are being developed in partnership with Intrexon Corporation. The lead therapeutic candidate in this program is Ad-RTS IL-12, a DNA therapeutic to enable controlled delivery of therapeutic interleukin-12 (IL-12), a protein important for an immune response to cancer. This is achieved by placing IL-12 under the control of Intrexon’s proprietary biological "switch" (the RheoSwitch Therapeutic System(R), RTS(R)) to turn on/off the therapeutic protein expression. Ad-RTS IL-12 is currently being tested in two Phase 2 studies, the first for the treatment of advanced melanoma, and the second in combination with palifosfamide for the treatment of non-resectable recurrent or metastatic breast cancer.
A highly focused team within the Company will be deployed in support of these programs. As a result, a restructuring plan is immediately being put into place to align staffing to current objectives and to marshal its resources toward achieving success with its synthetic biology programs.
"We are disappointed that the PICASSO 3 study did not meet its primary endpoint of progression-free survival," said Jonathan Lewis, M.D., Ph.D., Chief Executive Officer of ZIOPHARM. "We sincerely thank the trial investigators, clinical sites and the ZIOPHARM team for conducting a highly rigorous study, and are deeply appreciative to the cancer patients and their families for their participation in this trial."
Dr. Lewis added: "It is imperative that the Company rapidly focus its resources and efforts on our highly promising synthetic biology programs, employing therapeutic motifs that represent the next-generation in biotechnology."
Conference Call and Webcast March 26, 2013, at 8:30 AM ET
ZIOPHARM will host a conference call and live audio webcast today, March 26, 2013, at 8:30 AM ET to discuss the PICASSO 3 trial. The call can be accessed by dialing (877) 303-9850 (U.S. and Canada) or (408) 427-3732 (international). The passcode for the conference call is ‘ZIOPHARM.’ To access the live audio webcast, or the subsequent archived recording, visit the "Investors – Events & Presentations" section of the ZIOPHARM website at www.ziopharm.com. The webcast will be recorded and available for replay on the Company’s website for two (2) weeks.
About PICASSO 3
The PICASSO 3 trial is an international, randomized, double-blinded, placebo-controlled study. A total of 447 patients with metastatic soft tissue sarcoma were randomized to receive either intravenous palifosfamide plus doxorubicin (150 mg/m2 3 days every 21 days for a maximum of 6 cycles followed by 75 mg/m2 1 day every 21 days for a maximum of 6 cycles) or doxorubicin alone (75 mg/m2 1 day every 21 days for a maximum of 6 cycles). The primary endpoint for the study is improvement in PFS, with overall survival as a key secondary endpoint. Other secondary endpoints include quality of life assessments, and the safety and tolerability of this combination in this patient population. PICASSO 3 was conducted at more than 150 clinical centers in North America, Europe, South America, Australia, Israel and Asia.
About ZIOPHARM Oncology, Inc.:
ZIOPHARM Oncology is a biopharmaceutical company focused on the development and commercialization of new cancer therapies. The Company’s clinical programs include:
Ad-RTS IL-12 is currently being tested in two Phase 2 studies, the first for the treatment of advanced melanoma, and the second in combination with palifosfamide for the treatment of non-resectable recurrent or metastatic breast cancer. Ad-RTS IL-12 uses synthetic biology to enable controlled delivery of therapeutic interleukin-12 (IL-12), a protein important for an immune response to cancer. ZIOPHARM’s DNA synthetic biology platform is being developed in partnership with Intrexon Corporation and employs an inducible gene-delivery system that enables controlled delivery of genes that produce therapeutic proteins to treat cancer. This is achieved by placing IL-12 under the control of Intrexon’s proprietary biological "switch" (the RheoSwitch Therapeutic System(R), RTS(R)) to turn on/off the therapeutic protein expression at the tumor site.
Palifosfamide (ZIO-201) is a potent, bi-functional DNA alkylating agent that has activity in multiple tumors by evading typical resistance pathways. Palifosfamide is in the same class as bendamustine, cyclophosphamide, and ifosfamide.
Indibulin (ZIO-301) is a novel, tubulin binding agent that is expected to have several potential benefits, including oral dosing, application in multi-drug resistant tumors, no neuropathy and a tolerable toxicity profile. It is currently being studied in a Phase 1/2 trial in metastatic breast cancer.
Darinaparsin (ZIO-101) is a novel mitochondrial-and hedgehog-targeted agent (organic arsenic) currently in ongoing studies with Solasia Pharma K.K.
ZIOPHARM’s operations are located in Boston, MA, and New York City. Further information about ZIOPHARM may be found at www.ziopharm.com.
SOURCE: Ziopharm
Post Views: 65
