SAN DIEGO, CA, USA I June 3, 2013 I Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced results from a Phase 1b trial of PEGPH20 (PEGylated Recombinant Human Hyaluronidase), an investigational new biologic, in combination with gemcitabine for the treatment of patients with stage IV metastatic pancreatic cancer. The full data will be presented today at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting in a poster session from 1:15 PM-5:15 PM CDT and during a discussion session from 4:45 PM-5:45 PM CDT (E Hall D1, Abstract #4010).
In this single-arm Phase 1b trial, the overall response rate (complete response + partial response) by RECIST 1.1 criteria was 42 percent (95% CI 22 – 62) for those treated at therapeutic dose levels of PEGPH20 (1.6 and 3.0 µg/kg) as assessed by an independent radiology review (n=24). Additionally, in subjects with high levels of hyaluronan (HA), a substance found in a protective matrix that surrounds many pancreatic cancers, the overall response rate was 64 percent (7 of 11 subjects with available biopsy). Moreover, 43 percent (6 of 14 subjects) saw a reduction of at least 70 percent in serum carbohydrate antigen 19-9 (CA 19-9), a biomarker which often correlates with tumor cell burden.1
“Targeting the protective tumor matrix with an enzyme that digests hyaluronan is a novel treatment strategy for solid tumors. In addition to enabling chemotherapy drugs to penetrate more effectively into the tumor, removing hyaluronan may also slow its growth,” said lead investigator Sunil Hingorani, M.D., Ph.D., Associate Member of the Clinical Research and Public Health Divisions at Fred Hutchinson Cancer Research Center. “Pancreatic cancer is one of the most challenging cancers to treat. We are encouraged by these early stage clinical data, and look forward to further testing the potential of PEGPH20 in randomized trials in combination with the most active regimens available for patients today.”
Halozyme announced in April the initiation of a Phase 2 study, a multicenter, randomized clinical trial evaluating PEGPH20 in combination with nab-paclitaxel and gemcitabine for the treatment of stage IV pancreatic cancer. Halozyme is also developing a HA diagnostic tool to evaluate potential treatment benefit based on tumor HA levels for use in the randomized Phase 2 trial. This HA-diagnostic approach may also enable the testing of PEGPH20 in other HA-rich tumor types.
Additional Study Details
In the study, 28 stage IV treatment naïve pancreatic ductal adenocarcinoma patients with primary tumor located at head, body and tail were enrolled. Treatment was generally well tolerated, and the adverse event profile was consistent with those seen in previous studies of PEGPH20 as a single agent and as previously reported for gemcitabine alone. The most common adverse events for PEGPH20 were muscle spasms, myalgia and arthralgia (all grade 1/2). There was no evidence of new toxicities when used in combination with gemcitabine. Responses were observed in patients with lesions in all locations of the pancreas. The pharmacokinetics of PEGPH20 with gemcitabine were consistent with the pharmacokinetics of PEGPH20 as a single agent. Additionally, the pharmacodynamics results support the dosing regimen of PEGPH20 at 3µg/kg, which is being used in the Phase 2 trial.
About PEGPH20
Emerging data show that most pancreatic cancers surround themselves with a protective hyaluronan-rich matrix, which makes the disease difficult to treat and is itself an indicator of poor prognosis. PEGPH20 has been shown to deplete this matrix component from the tumor and rapidly changes the tumor microenvironment and metabolism, which may render it more vulnerable to therapy as well as inhibit tumor growth.
About Pancreatic Cancer
In most patients diagnosed with metastatic pancreatic adenocarcinoma, survival rates are the lowest of any cancer. In 2013, it is estimated that almost 45,000 new cases of pancreatic cancer will be diagnosed. About one-in-78 people in the U.S. will develop the disease, affecting equal numbers of men and women, almost always after the age of 45. Its tendency to spread prior to diagnosis makes it the fourth deadliest cancer with a less than six percent five-year relative survival rate, with more than 38,000 people succumbing to the disease each year.2-3
About Halozyme
Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company’s research focuses primarily on a family of human enzymes, known as hyaluronidases, which increase the absorption and dispersion of biologics, drugs and fluids. Halozyme’s pipeline addresses therapeutic areas, including diabetes, oncology and dermatology that have significant unmet medical need. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer, Baxter, ViroPharma and Intrexon. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com.
SOURCE: Halozyme Therapeutics
Post Views: 113
SAN DIEGO, CA, USA I June 3, 2013 I Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced results from a Phase 1b trial of PEGPH20 (PEGylated Recombinant Human Hyaluronidase), an investigational new biologic, in combination with gemcitabine for the treatment of patients with stage IV metastatic pancreatic cancer. The full data will be presented today at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting in a poster session from 1:15 PM-5:15 PM CDT and during a discussion session from 4:45 PM-5:45 PM CDT (E Hall D1, Abstract #4010).
In this single-arm Phase 1b trial, the overall response rate (complete response + partial response) by RECIST 1.1 criteria was 42 percent (95% CI 22 – 62) for those treated at therapeutic dose levels of PEGPH20 (1.6 and 3.0 µg/kg) as assessed by an independent radiology review (n=24). Additionally, in subjects with high levels of hyaluronan (HA), a substance found in a protective matrix that surrounds many pancreatic cancers, the overall response rate was 64 percent (7 of 11 subjects with available biopsy). Moreover, 43 percent (6 of 14 subjects) saw a reduction of at least 70 percent in serum carbohydrate antigen 19-9 (CA 19-9), a biomarker which often correlates with tumor cell burden.1
“Targeting the protective tumor matrix with an enzyme that digests hyaluronan is a novel treatment strategy for solid tumors. In addition to enabling chemotherapy drugs to penetrate more effectively into the tumor, removing hyaluronan may also slow its growth,” said lead investigator Sunil Hingorani, M.D., Ph.D., Associate Member of the Clinical Research and Public Health Divisions at Fred Hutchinson Cancer Research Center. “Pancreatic cancer is one of the most challenging cancers to treat. We are encouraged by these early stage clinical data, and look forward to further testing the potential of PEGPH20 in randomized trials in combination with the most active regimens available for patients today.”
Halozyme announced in April the initiation of a Phase 2 study, a multicenter, randomized clinical trial evaluating PEGPH20 in combination with nab-paclitaxel and gemcitabine for the treatment of stage IV pancreatic cancer. Halozyme is also developing a HA diagnostic tool to evaluate potential treatment benefit based on tumor HA levels for use in the randomized Phase 2 trial. This HA-diagnostic approach may also enable the testing of PEGPH20 in other HA-rich tumor types.
Additional Study Details
In the study, 28 stage IV treatment naïve pancreatic ductal adenocarcinoma patients with primary tumor located at head, body and tail were enrolled. Treatment was generally well tolerated, and the adverse event profile was consistent with those seen in previous studies of PEGPH20 as a single agent and as previously reported for gemcitabine alone. The most common adverse events for PEGPH20 were muscle spasms, myalgia and arthralgia (all grade 1/2). There was no evidence of new toxicities when used in combination with gemcitabine. Responses were observed in patients with lesions in all locations of the pancreas. The pharmacokinetics of PEGPH20 with gemcitabine were consistent with the pharmacokinetics of PEGPH20 as a single agent. Additionally, the pharmacodynamics results support the dosing regimen of PEGPH20 at 3µg/kg, which is being used in the Phase 2 trial.
About PEGPH20
Emerging data show that most pancreatic cancers surround themselves with a protective hyaluronan-rich matrix, which makes the disease difficult to treat and is itself an indicator of poor prognosis. PEGPH20 has been shown to deplete this matrix component from the tumor and rapidly changes the tumor microenvironment and metabolism, which may render it more vulnerable to therapy as well as inhibit tumor growth.
About Pancreatic Cancer
In most patients diagnosed with metastatic pancreatic adenocarcinoma, survival rates are the lowest of any cancer. In 2013, it is estimated that almost 45,000 new cases of pancreatic cancer will be diagnosed. About one-in-78 people in the U.S. will develop the disease, affecting equal numbers of men and women, almost always after the age of 45. Its tendency to spread prior to diagnosis makes it the fourth deadliest cancer with a less than six percent five-year relative survival rate, with more than 38,000 people succumbing to the disease each year.2-3
About Halozyme
Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company’s research focuses primarily on a family of human enzymes, known as hyaluronidases, which increase the absorption and dispersion of biologics, drugs and fluids. Halozyme’s pipeline addresses therapeutic areas, including diabetes, oncology and dermatology that have significant unmet medical need. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer, Baxter, ViroPharma and Intrexon. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com.
SOURCE: Halozyme Therapeutics
Post Views: 113
