SAN FRANCISCO, CA and BUFFALO, NY, USA I October 24, 2013 I Nektar Therapeutics (NKTR) and Roswell Park Cancer Institute (RPCI) announced today that the first patients have been dosed in a phase II investigator-sponsored study of etirinotecan pegol in patients with relapsed or refractory Small-Cell Lung Cancer (SCLC). The study is being conducted at Roswell Park under the direction of Alex Adjei, M.D., Ph.D., F.A.C.P., Senior Vice President for Clinical Research and Chair of the Department of Medicine at RPCI.
Etirinotecan pegol is the first long-acting topoisomerase-I inhibitor that concentrates in tumor tissue and provides sustained tumor suppression throughout the entire chemotherapy cycle.
“For patients with relapsed small-cell lung cancer, prognosis is poor with second-line therapy,” said Dr. Adjei. “Approved topoisomerase-I inhibitors have demonstrated anti-tumor activity in small-cell lung cancer, but their use is often hampered by significant toxicity and pharmacokinetics. Given this background, we are very interested in evaluating etirinotecan pegol as a potential treatment option for this patient population.”
The primary endpoint of the phase II study is the 18-week progression-free survival (PFS) rate. Secondary endpoints include objective response rate (ORR), overall survival (OS), median duration of response (DoR) and the safety profile of etirinotecan pegol in patients with relapsed SCLC. This single-stage study will evaluate etirinotecan pegol in two patient cohorts: chemo-resistant (those progressing within three months after completing first-line therapy) and chemo-sensitive (those progressing at three months or later after completing first-line therapy). The study is expected to enroll approximately 38 patients who will receive etirinotecan pegol once every three weeks as monotherapy.
“We are very pleased that Dr. Adjei has identified and proposed this study of single-agent etirinotecan pegol in this difficult to treat patient population,” said Robert Medve, M.D., Senior Vice President and Chief Medical Officer of Nektar Therapeutics. “This is the third phase II investigator-sponsored trial evaluating etirinotecan pegol and demonstrates our continued commitment to fully understanding etirinotecan pegol’s potential in resistant or refractory cancers where there are limited treatment options.”
About SCLC
Small-cell lung cancer (SCLC) is one of the most aggressive and lethal cancers in humans. It accounts for 15-20% of all lung cancer. Although standard combination cytotoxic chemotherapy agents have shown antitumor activity with initial responses of 70%–90% for both limited and extensive stages of SCLC, long-term survival is low and most patients eventually develop progressive disease within the first 2 years.1-3 Consequently, there is a need for new therapies that are safe and effective, which also improve overall survival and quality of life.
About Etirinotecan Pegol
Etirinotecan pegol is a unique, targeted topoisomerase-I inhibitor designed for prolonged tumor cell exposure. Etirinotecan pegol is believed to penetrate the vasculature of the tumor environment more readily than normal vasculature, increasing the concentration of active drug within tumor tissue to enhance antitumor activity. The BEACON study is a Phase 3 clinical study currently evaluating etirinotecan pegol for the treatment of locally recurrent or metastatic breast cancer. In addition to metastatic breast cancer, etirinotecan pegol is also being evaluated for the treatment of ovarian, colorectal, high-grade glioma and non-small-cell lung cancers.
About Roswell Park Cancer Institute
The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. Founded in 1898, RPCI is one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci@roswellpark.org. Follow Roswell Park on Facebook and Twitter.
About Nektar
Nektar Therapeutics (NKTR) is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar has a robust R&D pipeline of potentially high-value therapeutics in oncology, pain and other therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for naloxegol (NKTR-118), an investigational drug candidate, which has completed Phase 3 development as a once- daily, oral tablet for the treatment of opioid-induced constipation. For naloxegol, an MAA has been accepted for filing in Europe, and an NDA has been submitted for filing in the U.S. This agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of naloxegol and an opioid. NKTR-181, a novel mu-opioid analgesic molecule for chronic pain conditions, has completed Phase 2 development in osteoarthritis patients with chronic knee pain. NKTR-192, a novel mu-opioid analgesic molecule in development to treat acute pain is in Phase 1 clinical development. In oncology, etirinotecan pegol (NKTR-102) is being evaluated in a Phase 3 clinical study (the BEACON study) for the treatment of metastatic breast cancer and is also in a number of Phase 2 studies. In anti-infectives, Amikacin Inhale is in Phase 3 studies conducted by Bayer Healthcare to treat patients with Gram-negative pneumonia.
Nektar’s technology has enabled eight approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including UCB’s Cimzia® for Crohn’s disease and rheumatoid arthritis, Roche’s PEGASYS® for hepatitis C and Amgen’s Neulasta® for neutropenia. Additional development-stage products that leverage Nektar’s proprietary technology platform include Baxter’s BAX 855, a long-acting PEGylated rFVIII program, which is in Phase 3 clinical development.
Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.
SOURCE: Nektar Therapeutics
Post Views: 66
SAN FRANCISCO, CA and BUFFALO, NY, USA I October 24, 2013 I Nektar Therapeutics (NKTR) and Roswell Park Cancer Institute (RPCI) announced today that the first patients have been dosed in a phase II investigator-sponsored study of etirinotecan pegol in patients with relapsed or refractory Small-Cell Lung Cancer (SCLC). The study is being conducted at Roswell Park under the direction of Alex Adjei, M.D., Ph.D., F.A.C.P., Senior Vice President for Clinical Research and Chair of the Department of Medicine at RPCI.
Etirinotecan pegol is the first long-acting topoisomerase-I inhibitor that concentrates in tumor tissue and provides sustained tumor suppression throughout the entire chemotherapy cycle.
“For patients with relapsed small-cell lung cancer, prognosis is poor with second-line therapy,” said Dr. Adjei. “Approved topoisomerase-I inhibitors have demonstrated anti-tumor activity in small-cell lung cancer, but their use is often hampered by significant toxicity and pharmacokinetics. Given this background, we are very interested in evaluating etirinotecan pegol as a potential treatment option for this patient population.”
The primary endpoint of the phase II study is the 18-week progression-free survival (PFS) rate. Secondary endpoints include objective response rate (ORR), overall survival (OS), median duration of response (DoR) and the safety profile of etirinotecan pegol in patients with relapsed SCLC. This single-stage study will evaluate etirinotecan pegol in two patient cohorts: chemo-resistant (those progressing within three months after completing first-line therapy) and chemo-sensitive (those progressing at three months or later after completing first-line therapy). The study is expected to enroll approximately 38 patients who will receive etirinotecan pegol once every three weeks as monotherapy.
“We are very pleased that Dr. Adjei has identified and proposed this study of single-agent etirinotecan pegol in this difficult to treat patient population,” said Robert Medve, M.D., Senior Vice President and Chief Medical Officer of Nektar Therapeutics. “This is the third phase II investigator-sponsored trial evaluating etirinotecan pegol and demonstrates our continued commitment to fully understanding etirinotecan pegol’s potential in resistant or refractory cancers where there are limited treatment options.”
About SCLC
Small-cell lung cancer (SCLC) is one of the most aggressive and lethal cancers in humans. It accounts for 15-20% of all lung cancer. Although standard combination cytotoxic chemotherapy agents have shown antitumor activity with initial responses of 70%–90% for both limited and extensive stages of SCLC, long-term survival is low and most patients eventually develop progressive disease within the first 2 years.1-3 Consequently, there is a need for new therapies that are safe and effective, which also improve overall survival and quality of life.
About Etirinotecan Pegol
Etirinotecan pegol is a unique, targeted topoisomerase-I inhibitor designed for prolonged tumor cell exposure. Etirinotecan pegol is believed to penetrate the vasculature of the tumor environment more readily than normal vasculature, increasing the concentration of active drug within tumor tissue to enhance antitumor activity. The BEACON study is a Phase 3 clinical study currently evaluating etirinotecan pegol for the treatment of locally recurrent or metastatic breast cancer. In addition to metastatic breast cancer, etirinotecan pegol is also being evaluated for the treatment of ovarian, colorectal, high-grade glioma and non-small-cell lung cancers.
About Roswell Park Cancer Institute
The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. Founded in 1898, RPCI is one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci@roswellpark.org. Follow Roswell Park on Facebook and Twitter.
About Nektar
Nektar Therapeutics (NKTR) is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar has a robust R&D pipeline of potentially high-value therapeutics in oncology, pain and other therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for naloxegol (NKTR-118), an investigational drug candidate, which has completed Phase 3 development as a once- daily, oral tablet for the treatment of opioid-induced constipation. For naloxegol, an MAA has been accepted for filing in Europe, and an NDA has been submitted for filing in the U.S. This agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of naloxegol and an opioid. NKTR-181, a novel mu-opioid analgesic molecule for chronic pain conditions, has completed Phase 2 development in osteoarthritis patients with chronic knee pain. NKTR-192, a novel mu-opioid analgesic molecule in development to treat acute pain is in Phase 1 clinical development. In oncology, etirinotecan pegol (NKTR-102) is being evaluated in a Phase 3 clinical study (the BEACON study) for the treatment of metastatic breast cancer and is also in a number of Phase 2 studies. In anti-infectives, Amikacin Inhale is in Phase 3 studies conducted by Bayer Healthcare to treat patients with Gram-negative pneumonia.
Nektar’s technology has enabled eight approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including UCB’s Cimzia® for Crohn’s disease and rheumatoid arthritis, Roche’s PEGASYS® for hepatitis C and Amgen’s Neulasta® for neutropenia. Additional development-stage products that leverage Nektar’s proprietary technology platform include Baxter’s BAX 855, a long-acting PEGylated rFVIII program, which is in Phase 3 clinical development.
Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.
SOURCE: Nektar Therapeutics
Post Views: 66
