|Pfizer Submits New Drug Application for Palbociclib; BioBlast Receives Notice Of Allowance From USPTO For Ataxia|
|By Staff and Wire Reports|
|Monday, 18 August 2014 20:05|
Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. This designation was based on interim data from the PALOMA-1 trial.
The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Pfizer will communicate the Agency's decision.
“Today's submission marks an important milestone for Pfizer and palbociclib, and a potential advance for women with advanced breast cancer,” said Garry Nicholson, President, Pfizer Oncology.
About Palbociclib - Palbociclib is an investigational oral targeted agent that selectively inhibits cyclin-dependent kinases (CDKs) 4 and 6 to regain cell cycle control and block tumor cell proliferation.1
Loss of cell cycle control is a hallmark of cancer and CDK 4/6 are overactivated in numerous cancers, leading to loss of proliferative control.2,3 CDK 4/6 are key regulators of the cell cycle that trigger cellular progression from growth phase (G1) into phases associated with DNA replication (S).4,5 CDK 4/6, whose increased activity is frequent in estrogen receptor-positive (ER+) breast cancer (BC), are key downstream targets of ER signaling in ER+ BC.6,7 Preclinical data suggest that dual inhibition of CDK 4/6 and ER signaling is synergistic, and it has been shown to stop growth of ER+ BC cell lines in the G1 phase.
Palbociclib is not approved for any indication in any market.
About PALOMA-1 - PALOMA-1 (also known as Study 1003 and TRIO-18) is a Phase 2 trial designed to assess progression-free survival in post-menopausal women with ER+, HER2- advanced breast cancer receiving palbociclib (125 mg once daily for three out of four weeks in repeated cycles) in combination with letrozole versus letrozole alone (2.5 mg once daily on a continuous regimen). Final results from PALOMA-1 were presented at the American Association for Cancer Research (AACR) Annual Meeting 2014. PALOMA-1 was conducted in collaboration with the Jonsson Cancer Center's Revlon/UCLA Women's Cancer Research Program, led by Dr. Dennis Slamon.
Palbociclib Development Program in ER+, HER2- Breast Cancer - Pfizer has worked closely with investigators and international breast cancer experts to establish a robust development program for palbociclib in ER+, HER2- breast cancer across stages and treatment settings.
Pfizer has initiated two Phase 3 studies of palbociclib in advanced/metastatic breast cancer. PALOMA-2 (also known as Study 1008) is a randomized (2:1), multi-center, double blind Phase 3 study that evaluates palbociclib in combination with letrozole versus letrozole plus placebo as a first-line treatment for post-menopausal patients with ER+, HER2- advanced breast cancer. PALOMA-3 (also known as Study 1023) is a randomized (2:1), multi-center, double blind Phase 3 study that evaluates palbociclib in combination with fulvestrant versus fulvestrant plus placebo in women with hormone receptor-positive (HR+), HER2- metastatic breast cancer whose disease has progressed after prior endocrine therapy.
Additional, investigator-led studies of palbociclib in advanced/metastatic breast cancer and in early breast cancer are open and enrolling patients, including the PEARL and PENELOPE-B studies. PEARL, sponsored by Grupo Español de Investigación en Cáncer de Mama (GEICAM, Spanish Breast Cancer Research Group), with participation from the Central European Cooperative Oncology Group (CECOG), is a randomized (1:1), multi-center, open-label Phase 3 study evaluating palbociclib in combination with exemestane versus capecitabine in post-menopausal women with ER+, HER2- metastatic breast cancer whose disease was refractory to previous non-steroidal aromatase inhibitors (letrozole or anastrozole). PENELOPE-B is a randomized (1:1), double blind, placebo-controlled Phase 3 study comparing palbociclib plus standard endocrine therapy to placebo plus standard endocrine therapy in patients with HR+, HER2- early-stage breast cancer with certain features that suggest an increased risk for recurrence after completing pre-operative chemotherapy followed by surgery. This international study is sponsored by the German Breast Group (GBG).
BioBlast Pharma Ltd, (Nasdaq: ORPN) a clinical-stage biotechnology company committed to developing clinically meaningful therapies for patients with rare and ultra-rare genetic diseases, announced today it has received a notice of allowance from the United States Patent and Trademark Office (USPTO) on a composition-of-matter patent for its novel fusion protein for Friedrich's Ataxia (referred to as BB-FA) that is built on its mitochondrial protein replacement (mPRT) platform. The Company's breakthrough platform technology has produced drug candidates that have demonstrated efficacy in several mitochondrial protein deficiencies in cell and animal models.
"BB-FA for Friedrich's Ataxia is our most advanced mPRT preclinical program. We have developed this platform based on a recombinant protein containing targeting signals," stated Dalia Megiddo, MD, MBA Chief Executive Officer of BioBlast. "We are pleased to have received this notice of allowance which covers the significant innovations we have made in the delivery of therapeutic proteins into the mitochondria. We look forward to making further progress toward providing a therapy to help Friedrich's Ataxia patients in need of treatment."
Friedrich's Ataxia is an inherited disorder characterized by progressive deterioration of the muscular and nervous system that begins in the first or second decade of life and results in gait disturbance (ataxia), cognitive impairment, progressive heart disease and diabetes. According to Friedrich's Ataxia Research Alliance (FARA), about 1:50,000 people in the U.S. suffer from Friedrich's Ataxia. Most patients are wheelchair-bound within 15 years of diagnosis. Most patients do not survive beyond the fourth or fifth decade of life.
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