美国乳癌新药Abraxane在三期临床试验中表现出色
这个帖子发布于 21 年零 205 天前，其中的信息可能已发生改变或有所发展。
美国药物伙伴公司（American Pharmaceutical Partners）（APPX）周五表示，他们从常用旧药泰素（Taxol）所改良的乳癌药物Abraxane，可以更大剂量地使用，并能减少大多数副作用的影响。
该公司将百时美·施贵宝（Bristol-Myers Squibb）（BMY）药物泰素中的活性成份紫杉醇（paclitaxel），用自然产生的白蛋白装制成胶囊，而不像标准药物使用溶剂来作为药物的输送工具。
该公司在9月曾表示，在用454位癌细胞扩散至身体其它部位的病人所做的最后阶段试验中，Abraxane更为安全，同时效用超过了泰素。他们将在周五圣安东尼奥乳癌研讨会年会上公布实际的临床数据。
由于性状改变的新药旨在提供更安全的治疗，因此可以被更大剂量地使用。在三期临床试验中，该公司使用的紫杉醇剂量比标准泰素高出50%。
他们表示，在连续使用Abraxane达三周的患者中，有33%的人肿瘤缩小，而同样在使用泰素三周的患者中，肿瘤缩小的仅有19%，两者的差距在统计意义上非常显著。
另外，使用Abraxane的患者平均有21.9周没有出现病情恶化的现象，而在使用泰素的患者中，这一数字为16.1周，同时Abraxane也表现出令人满意的显著优势。
除了含有大剂量的紫杉醇，使用泰素的病人还出现白细胞数量显著的缓慢减少，这种嗜中性白细胞减少症，通常是化疗产生的后果，使患者变得更易感染。
使用泰素的患者通常在接受注射前服用类固醇，以避免对癌症药物的过敏反应。而与之相反，98%的Abraxane使用者没有提前服用类固醇，也没有产生严重的过敏反应。
美国药物伙伴公司称，10%的Abraxane使用者出现神经系统的疾病，如神经麻木或者疼痛，而泰素使用者中出现此现象的只有2%。不过出现此类症状的Abraxane使用者在平均22天后症状即消失，而使用泰素使用者中，症状平均维持了79天后才会消失。
Detailed Positive ABRAXANE(TM) Phase III Data Released at San Antonio Breast Cancer Symposium: Patients With Metastatic Breast Cancer Treated With ABRAXANE(TM) Achieve Almost Double the Tumor Response Rate and Longer Time to Tumor Progression Compared With TAXOL(R)
Friday December 5, 4:30 pm ET
SCHAUMBURG, Ill. and SANTA MONICA, Calif., Dec. 5 /PRNewswire/ -- American Pharmaceutical Partners, Inc. (Nasdaq: APPX - News; APP) and ABRAXIS Oncology, the proprietary drug division of APP, today announced positive results of the randomized, controlled Phase III clinical trial in patients with metastatic breast cancer comparing the investigational product ABRAXANE(TM) (formerly ABI-007) to the Cremophor solvent-based TAXOL. A detailed analysis of the study was presented by Joyce O'Shaughnessy, M.D., Co-Director, Breast Cancer Research and Director, Breast Cancer Prevention at Baylor-Charles A. Sammons Cancer Center, US Oncology in Dallas, Texas, and William Gradishar, M.D., FACP, Associate Professor of Medicine, Division of Hematology and Medical Oncology and Co-Director, Lynn Sage Breast Cancer Program at Northwestern University in Evanston, Illinois, to an audience of oncologists at a late-breaking session and Scientific Symposium at the San Antonio Breast Cancer Symposium held in San Antonio, Texas last Friday evening.
Patients with metastatic breast cancer receiving the solvent-free nanoparticle paclitaxel, ABRAXANE(TM) (n=229 patients) achieved almost a doubling of the tumor response rate when compared to those patients receiving Bristol-Myers Squibb's TAXOL (n=225). "The robustness of the data is underscored by the fact that statistically superior response rates with ABRAXANE(TM) compared to TAXOL were noted regardless of whether the data was assessed by the blinded, independent radiology review or the investigator assessment," said Joyce O'Shaughnessy, M.D.
Although the ABRAXANE(TM) data and labeling remain subject to FDA review, the Phase III study demonstrated potentially important advantages over TAXOL as a treatment for metastatic breast cancer patients, based on: higher response rates; longer time to tumor progression; absence of severe hypersensitivity reactions without the need for premedication; less neutropenia despite a higher dose infused over a shorter period of 30 minutes; and, a rapid recovery from sensory neuropathy compared with TAXOL, albeit with a somewhat higher incidence consistent with the higher dosage administered.
"It is clear that the solvent Cremophor is not an innocent bystander," said William Gradishar, M.D., the Principal Investigator of the study. "The findings of this Phase III clinical trial provide the first clinical evidence that Cremophor may be responsible not only for the severe hypersensitvity reactions that necessitate steroid pre-medication, but that the toxic effects of this solvent on patients may be more far-reaching than previously recognized. Data from this trial suggest that Cremophor itself may be responsible for the loss of protective white blood cells, by suppressing the bone marrow, and, furthermore, that the solvent-induced damage to nerve fibres, rather than paclitaxel itself, may account for the prolonged recovery of peripheral neuropathy noted with TAXOL."
"We are extremely pleased that the increase in anti-tumor activity we had seen with ABRAXANE(TM) in preclinical studies was confirmed in this Phase III trial, and further translated into an increased time to tumor progression in patients with metastatic breast cancer," said Michael J. Hawkins, M.D., Chief Medical Officer at American BioScience, Inc., the company responsible for developing ABRAXANE(TM).
"Our preclinical data indicated that higher intratumor concentrations of paclitaxel were achieved following administration of ABRAXANE(TM), compared to equal doses of TAXOL. This effect, coupled with our ability to increase the dose of paclitaxel administered, predicted that ABRAXANE(TM) would have more anti-tumor activity than TAXOL. This is now supported by the results of our randomized Phase III study. We will now expeditiously complete filing of the NDA, which has been granted fast-track designation."
Protosphere(TM) Nanoparticle Albumin-Bound (nab) Technology - The Foundation Technology for ABRAXANE(TM)
American BioScience's Protosphere Nanoparticle Albumin-Bound (nab) technology integrates biocompatible proteins with drugs to create the amorphous, nanoparticle form of the drug. These nanoparticles act as biologic nanotransporters for hydrophobic drugs such as paclitaxel, which may result in increased intracellular availability of the chemotherapeutic agent at the tumor site. At the San Antonio conference, American BioScience presented, for the first time, data that provides evidence of a novel receptor-mediated albumin-bound transporter mechanism for paclitaxel believed to play a role in increased penetration of the active drug into tumor tissue, by a mechanism of "transcytosis."
About American Pharmaceutical Partners, Inc. and American BioScience, Inc.
American Pharmaceutical Partners, Inc. (APP), a majority owned subsidiary of American BioScience, Inc., is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets. APP has acquired the exclusive North American rights to manufacture and market ABRAXANE(TM), a proprietary nanoparticle injectable oncology product that has completed Phase III clinical trials for metastatic breast cancer and for which the FDA has granted "Fast Track" designation. The NDA submission has commenced and is ongoing. The company believes that it has established the only commercial scale protein-engineered nanoparticle manufacturing capability in the United States. For more information, visit APP's website at www.appdrugs.com.
American BioScience, Inc., based in Santa Monica, CA, is a privately held biotechnology company focused on the discovery, development and delivery of next generation therapeutic entities for the treatment of life-threatening diseases.
Statements contained in this press release, which are not historical facts, are forward-looking statements, as the term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements, whether expressed or implied, are subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated, due to a number of factors, which include, but are not limited to, the impact of pharmaceutical industry regulation, the difficulty in predicting the timing or outcome of product development efforts and FDA or other regulatory approvals or actions including the approval of ABRAXANE(TM), the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, the ability to successfully manufacture products in a time-sensitive and cost effective manner, the acceptance and demand of new pharmaceutical products, the impact of patents and other proprietary rights held by competitors and other third parties, actual results achieved in further Phase II and III trials for ABRAXANE(TM) may or may not be consistent with results achieved to date, the timing and completion of the ABRAXANE(TM) filing, the fact that the FDA has not reviewed the current Phase III data and may not agree with the company's conclusions to support approval, and other risk factors discussed in the Company's Form 10-K and other documents filed by the Company with the Securities and Exchange Commission from time to time. These forward-looking statements represent the Company's judgment as of the date of this press release. The Company disclaims any intent or obligation to update these forward-looking statements.
该公司将百时美·施贵宝（Bristol-Myers Squibb）（BMY）药物泰素中的活性成份紫杉醇（paclitaxel），用自然产生的白蛋白装制成胶囊，而不像标准药物使用溶剂来作为药物的输送工具。
该公司在9月曾表示，在用454位癌细胞扩散至身体其它部位的病人所做的最后阶段试验中，Abraxane更为安全，同时效用超过了泰素。他们将在周五圣安东尼奥乳癌研讨会年会上公布实际的临床数据。
由于性状改变的新药旨在提供更安全的治疗，因此可以被更大剂量地使用。在三期临床试验中，该公司使用的紫杉醇剂量比标准泰素高出50%。
他们表示，在连续使用Abraxane达三周的患者中，有33%的人肿瘤缩小，而同样在使用泰素三周的患者中，肿瘤缩小的仅有19%，两者的差距在统计意义上非常显著。
另外，使用Abraxane的患者平均有21.9周没有出现病情恶化的现象，而在使用泰素的患者中，这一数字为16.1周，同时Abraxane也表现出令人满意的显著优势。
除了含有大剂量的紫杉醇，使用泰素的病人还出现白细胞数量显著的缓慢减少，这种嗜中性白细胞减少症，通常是化疗产生的后果，使患者变得更易感染。
使用泰素的患者通常在接受注射前服用类固醇，以避免对癌症药物的过敏反应。而与之相反，98%的Abraxane使用者没有提前服用类固醇，也没有产生严重的过敏反应。
美国药物伙伴公司称，10%的Abraxane使用者出现神经系统的疾病，如神经麻木或者疼痛，而泰素使用者中出现此现象的只有2%。不过出现此类症状的Abraxane使用者在平均22天后症状即消失，而使用泰素使用者中，症状平均维持了79天后才会消失。
Detailed Positive ABRAXANE(TM) Phase III Data Released at San Antonio Breast Cancer Symposium: Patients With Metastatic Breast Cancer Treated With ABRAXANE(TM) Achieve Almost Double the Tumor Response Rate and Longer Time to Tumor Progression Compared With TAXOL(R)
Friday December 5, 4:30 pm ET
SCHAUMBURG, Ill. and SANTA MONICA, Calif., Dec. 5 /PRNewswire/ -- American Pharmaceutical Partners, Inc. (Nasdaq: APPX - News; APP) and ABRAXIS Oncology, the proprietary drug division of APP, today announced positive results of the randomized, controlled Phase III clinical trial in patients with metastatic breast cancer comparing the investigational product ABRAXANE(TM) (formerly ABI-007) to the Cremophor solvent-based TAXOL. A detailed analysis of the study was presented by Joyce O'Shaughnessy, M.D., Co-Director, Breast Cancer Research and Director, Breast Cancer Prevention at Baylor-Charles A. Sammons Cancer Center, US Oncology in Dallas, Texas, and William Gradishar, M.D., FACP, Associate Professor of Medicine, Division of Hematology and Medical Oncology and Co-Director, Lynn Sage Breast Cancer Program at Northwestern University in Evanston, Illinois, to an audience of oncologists at a late-breaking session and Scientific Symposium at the San Antonio Breast Cancer Symposium held in San Antonio, Texas last Friday evening.
Patients with metastatic breast cancer receiving the solvent-free nanoparticle paclitaxel, ABRAXANE(TM) (n=229 patients) achieved almost a doubling of the tumor response rate when compared to those patients receiving Bristol-Myers Squibb's TAXOL (n=225). "The robustness of the data is underscored by the fact that statistically superior response rates with ABRAXANE(TM) compared to TAXOL were noted regardless of whether the data was assessed by the blinded, independent radiology review or the investigator assessment," said Joyce O'Shaughnessy, M.D.
Although the ABRAXANE(TM) data and labeling remain subject to FDA review, the Phase III study demonstrated potentially important advantages over TAXOL as a treatment for metastatic breast cancer patients, based on: higher response rates; longer time to tumor progression; absence of severe hypersensitivity reactions without the need for premedication; less neutropenia despite a higher dose infused over a shorter period of 30 minutes; and, a rapid recovery from sensory neuropathy compared with TAXOL, albeit with a somewhat higher incidence consistent with the higher dosage administered.
"It is clear that the solvent Cremophor is not an innocent bystander," said William Gradishar, M.D., the Principal Investigator of the study. "The findings of this Phase III clinical trial provide the first clinical evidence that Cremophor may be responsible not only for the severe hypersensitvity reactions that necessitate steroid pre-medication, but that the toxic effects of this solvent on patients may be more far-reaching than previously recognized. Data from this trial suggest that Cremophor itself may be responsible for the loss of protective white blood cells, by suppressing the bone marrow, and, furthermore, that the solvent-induced damage to nerve fibres, rather than paclitaxel itself, may account for the prolonged recovery of peripheral neuropathy noted with TAXOL."
"We are extremely pleased that the increase in anti-tumor activity we had seen with ABRAXANE(TM) in preclinical studies was confirmed in this Phase III trial, and further translated into an increased time to tumor progression in patients with metastatic breast cancer," said Michael J. Hawkins, M.D., Chief Medical Officer at American BioScience, Inc., the company responsible for developing ABRAXANE(TM).
"Our preclinical data indicated that higher intratumor concentrations of paclitaxel were achieved following administration of ABRAXANE(TM), compared to equal doses of TAXOL. This effect, coupled with our ability to increase the dose of paclitaxel administered, predicted that ABRAXANE(TM) would have more anti-tumor activity than TAXOL. This is now supported by the results of our randomized Phase III study. We will now expeditiously complete filing of the NDA, which has been granted fast-track designation."
Protosphere(TM) Nanoparticle Albumin-Bound (nab) Technology - The Foundation Technology for ABRAXANE(TM)
American BioScience's Protosphere Nanoparticle Albumin-Bound (nab) technology integrates biocompatible proteins with drugs to create the amorphous, nanoparticle form of the drug. These nanoparticles act as biologic nanotransporters for hydrophobic drugs such as paclitaxel, which may result in increased intracellular availability of the chemotherapeutic agent at the tumor site. At the San Antonio conference, American BioScience presented, for the first time, data that provides evidence of a novel receptor-mediated albumin-bound transporter mechanism for paclitaxel believed to play a role in increased penetration of the active drug into tumor tissue, by a mechanism of "transcytosis."
About American Pharmaceutical Partners, Inc. and American BioScience, Inc.
American Pharmaceutical Partners, Inc. (APP), a majority owned subsidiary of American BioScience, Inc., is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets. APP has acquired the exclusive North American rights to manufacture and market ABRAXANE(TM), a proprietary nanoparticle injectable oncology product that has completed Phase III clinical trials for metastatic breast cancer and for which the FDA has granted "Fast Track" designation. The NDA submission has commenced and is ongoing. The company believes that it has established the only commercial scale protein-engineered nanoparticle manufacturing capability in the United States. For more information, visit APP's website at www.appdrugs.com.
American BioScience, Inc., based in Santa Monica, CA, is a privately held biotechnology company focused on the discovery, development and delivery of next generation therapeutic entities for the treatment of life-threatening diseases.
Statements contained in this press release, which are not historical facts, are forward-looking statements, as the term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements, whether expressed or implied, are subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated, due to a number of factors, which include, but are not limited to, the impact of pharmaceutical industry regulation, the difficulty in predicting the timing or outcome of product development efforts and FDA or other regulatory approvals or actions including the approval of ABRAXANE(TM), the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, the ability to successfully manufacture products in a time-sensitive and cost effective manner, the acceptance and demand of new pharmaceutical products, the impact of patents and other proprietary rights held by competitors and other third parties, actual results achieved in further Phase II and III trials for ABRAXANE(TM) may or may not be consistent with results achieved to date, the timing and completion of the ABRAXANE(TM) filing, the fact that the FDA has not reviewed the current Phase III data and may not agree with the company's conclusions to support approval, and other risk factors discussed in the Company's Form 10-K and other documents filed by the Company with the Securities and Exchange Commission from time to time. These forward-looking statements represent the Company's judgment as of the date of this press release. The Company disclaims any intent or obligation to update these forward-looking statements.
