Nanotechnology Now - Press Release: Over 30 Scientific Presentations at ASCO Exploring ABRAXANE’s Expanded Potential in Multiple Difficult-to-Treat Cancers

Home > Press > Over 30 Scientific Presentations at ASCO Exploring ABRAXANE’s Expanded Potential in Multiple Difficult-to-Treat Cancers

Abstract:
Clinical Data in Lung, Pancreatic, Melanoma, Ovarian, Head & Neck, Bladder and Triple-Negative Breast Cancers to be Presented at 46th Meeting of the American Society of Clinical Oncology

Over 30 Scientific Presentations at ASCO Exploring ABRAXANE’s Expanded Potential in Multiple Difficult-to-Treat Cancers

Los Angeles, CA | Posted on May 18th, 2010

Abraxis BioScience, Inc. (NASDAQ:ABII) today announced that 32 scientific abstracts will be presented at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO), June 4-8 in Chicago, evaluating the use of nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable suspension; paclitaxel protein albumin-bound particles for injectable suspension). The clinical findings of this nab-driven chemotherapy will be presented in the treatment of multiple tumor types, including some of the most difficult-to-treat cancers.

Among research to be presented are late-breaking results from the Phase III study in first-line advanced non-small cell lung cancer (NSCLC) and data on the Phase II study of advanced pancreatic cancer patients.

NSCLC (Abstract #LBA7511): An oral session presenting the results of the Phase III study evaluating the use of nab-paclitaxel in combination with carboplatin for the first-line treatment of patients with advanced NSCLC. Abraxis announced in March that its registrational Phase III clinical study of nab-paclitaxel in NSCLC met the primary endpoint, demonstrating a statistically significant improvement in overall response rate as compared to Taxol® (paclitaxel), both administered with carboplatin. The data will be presented for the first time at ASCO.

Pancreatic cancer (Abstract #4120): The results from a Phase II trial evaluating nab-paclitaxel monotherapy in patients with advanced pancreatic cancer who have progressed on gemcitabine-based therapy will be presented.

"We continue to see evidence of the value of ABRAXANE in improving outcomes for patients with difficult-to-treat tumors," said Patrick Soon-Shiong, M.D., Executive Chairman and founder of Abraxis BioScience. "And importantly, we are improving our understanding of how the nab-driven drug delivery mechanism works when administered either as a single agent or when given in combination. This nab-driven chemotherapy provides a new paradigm of activating a previously unrecognized tumor upregulated path through the blood vessel wall, potentially allowing drugs to enter into the stromal microenvironment, providing the opportunity for collapse of this tumor stroma, and enhancing delivery of the nab-driven drug (together with the drug administered in combination) to the tumor cell itself. We are excited that this paradigm may be applicable to the multiple difficult-to-treat tumor types such as metastatic pancreatic cancer, non-small cell lung cancer and metastatic melanoma and is the subject of ongoing pre-clinical and clinical research."

Data presented at this year's meeting include studies evaluating nab-paclitaxel as monotherapy or in combination to treat lung, pancreatic, melanoma, ovarian and breast cancers, as well as studies assessing the value of SPARC, an albumin-binding protein, as a biomarker and predictor of response to nab-paclitaxel. Among the studies to be presented:

NSCLC

Results of a Randomized, Phase III Trial of nab-paclitaxel and carboplatin compared with cremophor-based paclitaxel and carboplatin as first-line therapy in advanced NSCLC
Abstract: LBA 7511 (Oral), Monday, June 7, 5:30 p.m., E Hall, D2

In vivo assessment of the effects of bevacizumab in advanced non-small cell lung cancer (NSCLC)
Abstract: 7612, Poster: 43, Sunday, June 6, 8 a.m. - 12 p.m., S Hall, A2

Phase II trial of nab-paclitaxel plus carboplatin for advanced NSCLC in patients at risk of bleeding from VEGF-directed therapies.
Abstract: TPS314, Monday, June 7, 8 a.m. - 12 p.m., S Hall, A2

A Phase I Study of nab-paclitaxel (nP) with Carboplatin(C) & Thoracic Radiation (TRT) in Patients with Locally Advanced NSCLC
Abstract: e17504

Pancreatic

A Phase II trial of nab-paclitaxel (NP) in patients with advanced pancreatic cancer (PC) who have progressed on gemcitabine (G)-based therapy
Abstract: 4120, Poster: 29A, Sunday, June 6, 2 p.m. - 6 p.m., S Hall, A2

Melanoma

An open-label, multicenter, Phase III trial of nab-paclitaxel (NP) vs dacarbazine (DTIC) in previously untreated patients (PTs) with metastatic malignant melanoma (MMM)
Abstract: TPS314, Monday, June 7, 8 a.m. - 12 p.m., S Hall, A2

Tumor SPARC microenvironment signature (SMS) and plasma levels in a phase II trial of unresectable stage IV melanoma treated with nab-paclitaxel and carboplatin: A translational study of NCCTG trial N057E
Abstract: 8578, Poster: 43G, Sunday, June 6, 8 a.m. - 12 p.m., S Hall, A2

Oblimersen 1-hour IV infusion in combination with temozolomide and albumin-bound paclitaxel in patients with advanced melanoma
Abstract: 8561, Poster: 54A, Sunday, June 6, 8 a.m. - 12 p.m., S Hall, A 2

Ovarian

A phase II study of bevacizumab with nab-paclitaxel in patients with recurrent, platinum-resistant primary epithelial ovarian or primary peritoneal carcinoma.
Abstract: 5009, Poster: 1 (Poster Discussion), Sunday, June 6, 5 p.m. - 6 p.m., E Arie Crown Theater

A phase II evaluation of nab-paclitaxel in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer: A Gynecologic Oncology Group (GOG) study.
Abstract: 5010, Poster: 2 (Poster Discussion), Sunday, June 6, 5 p.m. - 6 p.m., E Arie Crown Theater

A phase II, nonrandomized study of nab-paclitaxel plus carboplatin in patients with recurrent platinum-sensitive ovarian or primary peritoneal cancer.
Abstract: 5011, Poster: 3 (Poster Discussion), Sunday, June 6, 5 p.m. - 6 p.m., E Arie Crown Theater

SPARC

Effect of plasma SPARC on outcome in cancer models
Abstract: 10600, Poster: 48B, Saturday, June 5, 8 a.m. - 12 p.m., S Hall, A2

SPARC microenvironment signature (SMS) analysis of a phase II trial of neoadjuvant gemcitabine (G), epirubicin (E), and nab-paclitaxel (nab-P) in locally advanced breast cancer (LABC)
Abstract: 10574, Poster 44H, Saturday, June 5, 8 a.m. - 12 p.m., S Hall, A2

Tumor SPARC microenvironment signature (SMS) and plasma levels in a phase II trial of unresectable stage IV melanoma treated with nab-paclitaxel and carboplatin: A translational study of NCCTG trial N057E
Abstract: 8578, Poster: 54A, Sunday, June 6, 8 a.m. - 12 p.m., S Hall, A2

Breast

Gene signatures as predictors of response to neoadjuvant chemotherapy (NCT) with docetaxel, doxorubicin, cyclophosphamide (TAC), or AC and nab-paclitaxel (nab-P) and carboplatin +/- trastuzumab in patients (pts) with stage II-III and inflammatory breast cancer (IBC)
Abstract: 540, Poster: 1E, Saturday, June 5, 2 p.m. - 6 p.m., S Hall, A2

Circulating tumor cells (CTC) and circulating endothelial cells (CEC) in patients (pts) receiving adjuvant bevacizumab (B) plus dose-dense (dd) doxorubicin/cyclophosphamide (AC) followed by nab-paclitaxel (nab-P) for early-stage breast cancer (ESBC)
Abstract: 579, Poster: 6D, Saturday, June 5, 2 p.m. - 6 p.m., S Hall, A2

Phase II trial of neoadjuvant chemotherapy (NCT) with weekly nanoparticle albumin-bound paclitaxel (nab-P), carboplatin (CBP), and bevacizumab (BEV) in women with clinical stages II-III breast cancer (BC): Pathologic response prediction by changes in angiogenic volume (AV) by dynamic contrast magnetic resonance imaging (DCE-MRI)
Abstract: 604, Poster: 9E, Saturday, June 5, 2 p.m. - 6 p.m., S Hall, A2

Use of SPARC, EGFR, and VEGFR expression to predict response to nab-paclitaxel (nabP)/carboplatin (C)/bevacizumab (B) chemotherapy in triple-negative metastatic breast cancer (TNMBC)
Abstract: 1109, Poster: 35B, Saturday, June 5, 2 p.m. - 6 p.m., S Hall, A2

An open-label, phase II study of weekly nab-paclitaxel as first-line therapy for patients (pts) with metastatic breast cancer (MBC): Safety update
Abstract: 1127, Poster: 37D, Saturday, June 5, 2 p.m. - 6 p.m., S Hall, A2

A multi-institutional double-blind phase II study evaluating response and surrogate biomarkers to carboplatin and nab-paclitaxel (CP) with or without vorinostat as preoperative systemic therapy (PST) in HER2-negative primary operable breast cancer (TBCRC008).
Abstract: TPS111, Monday, June 7, 8 a.m. - 12 p.m., S Hall, A2

ICE II: An investigational randomized phase II study on epirubicin (E) plus cyclophospamide (C) (or CMF) versus nab-paclitaxel plus capecitabine (PX) as adjuvant chemotherapy for elderly nonfrail patients with an increased risk for relapse of a primary carcinoma of the breast.
Abstract: TPS104, Monday, June 7, 8 a.m. - 12 p.m., S Hall, A2

Neoadjuvant bevacizumab with weekly nanoparticle albumin bound nab-paclitaxel plus carboplatin followed by doxorubicin plus cyclophosphamide (AC) for triple-negative breast cancer.
Abstract: TPS100, Monday, June 7, 8 a.m. - 12 p.m., S Hall, A2

Neoadjuvant therapy for stage II-III breast cancer with weekly Abraxane®, q3week carboplatin and targeted agents: Interim dose delivery and toxicity data
Abstract: e11010

SPARC microenvironment signature (SMS) in patients treated with nab-paclitaxel (nabP)/carboplatin (C)/bevacizumab(B) for triple-negative metastatic breast cancer (TNMBC)
Abstract: e21040

Solid Tumor

A phase I study of the mTOR inhibitor sirolimus in combination with nanoparticle albumin-bound paclitaxel (nab-P)
Abstract: 2534, Poster: 20 (Poster Discussion), Saturday, June 5, 12 p.m. - 1 p.m., E354b

A phase I study of two different schedules of nab-paclitaxel (nab-p) with ascending doses of vandetanib (V) in patients (pts) with advanced solid tumors.
Abstract: 3059, Poster: 14C, Monday, June 7, 8 a.m. - 12 p.m., S Hall, A2

A phase I study of hepatic arterial infusion of Abraxane in patients with predominant hepatic metastases
Abstract: e13044

Bladder

Phase I trial of intravesical nanoparticle albumin-bound paclitaxel in the treatment of BCG-refractory non-muscle-invasive bladder cancer
Abstract: 4542, Poster: 23 (Poster Discussion), Saturday, June 5, 5 p.m. - 6 p.m., E Hall, D2

A phase II study of single-agent nab-paclitaxel as second-line therapy in patients with metastatic urothelial carcinoma.
Abstract: TPS23, Monday, June 7, 8 a.m. - 12 p.m., S Hall, A2

Head & Neck

Interim safety analysis of a novel induction chemotherapy (IC) regimen of weekly nanoparticle albumin-bound (nab-) paclitaxel and cetuximab with every 3 week cisplatin and 5-FU in patients with locally advanced nonmetastatic head and neck squamous cell carcinoma (HNSCC)
Abstract: 5564, Poster: 14B, Sunday, June 6, 8 a.m. - 12 p.m., S Hall, A2

Clinical response rate at primary tumor site by WHO criteria following an Induction Chemotherapy regimen of weekly paclitaxel albumin-bound nanoparticles (Abraxane) and Cetuximab with every 3 week Cisplatin and 5-FU in patients with locally advanced non-metastatic head and neck squamous cell carcinoma (HNSCC)
Abstract: e16028

Health Economics

Cost utility analysis of nab-paclitaxel weekly or q3w compared with docetaxel q3w as first-line therapy in metastatic breast cancer (MBC)
Abstract: e16545

FORWARD-LOOKING STATEMENTS

The statements contained in this press release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the clinical development plan, and the timing and scope of clinical studies and trials, for ABRAXANE and the global commercialization of ABRAXANE. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, the fact that results from pre-clinical studies may not be predictive of results to be obtained in other pre-clinical studies or future clinical trials; delays in commencement and completion of clinical studies or trials, including slower than anticipated patient enrollment and adverse events occurring during the clinical trials; decisions by regulatory authorities regarding whether and when to approve ABRAXANE or product candidates for various indications as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of ABRAXANE and other products and product candidates; unexpected safety, efficacy or manufacturing issues with respect to ABRAXANE or product candidates; the need for additional data or clinical studies for ABRAXANE or product candidates; regulatory developments (domestic or foreign) involving the company's manufacturing facilities; the market adoption and demand of ABRAXANE and other products, the costs associated with the ongoing launch of ABRAXANE; research and development associated with the nab® technology platform; the impact of pharmaceutical industry regulation; 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; and the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2009 and in other documents it has filed with the Securities and Exchange Commission.

The information contained in this press release is as of the date of this release. Abraxis assumes no obligations to update any forward-looking statements contained in this press release as the result of new information or future events or developments.

TAXOL® is a registered trademark of Bristol-Myers Squibb Company.

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About Abraxis BioScience
Abraxis BioScience is a fully integrated global biotechnology company dedicated to the discovery, development and delivery of next-generation therapeutics and core technologies that offer patients safer and more effective treatments for cancer and other critical illnesses. The company's portfolio includes chemotherapeutic compound (ABRAXANE®), which is based on the company's proprietary tumor targeting technology known as the nab® platform. The first FDA approved product to use this nab® platform, ABRAXANE, was launched in 2005 for the treatment of metastatic breast cancer and is now approved in 39 countries. The company continues to expand the nab® platform through a robust clinical program and deep product pipeline. Abraxis trades on the NASDAQ Global Market under the symbol ABII. For more information about the company and its products, please visit www.abraxisbio.com.

About nab®-Driven Chemotherapy

Abraxis BioScience has developed a proprietary nanoparticle albumin-bound (nab) technology which leverages albumin nanoparticles for the active and targeted delivery of chemotherapeutics to the tumor. This nab-driven chemotherapy provides a new paradigm for penetrating the blood-stroma barrier to reach the tumor cell. The proposed mechanism of delivery of this nab-driven chemotherapy is thought to be by targeting a previously unrecognized tumor-activated, albumin-specific biologic pathway with a nanoshell of the human blood protein albumin. This nano-shuttle system is believed to activate an albumin-specific (Gp60) receptor-mediated transcytosis path through the cell wall of proliferating tumor cells, using caveolin-1 activated caveolar transport. Once in the stromal micro-environment, the albumin-bound drug may be preferentially localized by a second albumin-specific binding protein, SPARC, a protein secreted into the stroma by tumor cells. The resulting collapse of stroma surrounding the tumor cell may thus enhance the delivery of the nab-chemotherapeutic to the intracellular core of the tumor cell itself.

About ABRAXANE®

ABRAXANE is the first clinical validation of the nanoparticle albumin bound (nab) technology platform and is a treatment option for metastatic breast cancer. This protein-bound chemotherapy agent combines paclitaxel with albumin, a naturally-occurring human blood protein. ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: expanded applications for metastatic breast, non-small cell lung, malignant melanoma, pancreatic and gastric.

The U.S. Food and Drug Administration approved ABRAXANE for Injectable Suspension (paclitaxel protein albumin-bound particles for injectable suspension) (albumin-bound) in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. For the full prescribing information for ABRAXANE please visit http://www.abraxane.com.

IMPORTANT SAFETY INFORMATION

The use of ABRAXANE has not been studied in patients with hepatic or renal dysfunction. In the randomized controlled trial, patients were excluded for baseline serum bilirubin >1.5 mg/dL or baseline serum creatinine >2 mg/dL.

ABAXANE can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with ABRAXANE.

Men should be advised to not father a child while receiving treatment with ABRAXANE.

It is recommended that nursing be discontinued when receiving ABRAXANE therapy.

ABRAXANE contains albumin (human), a derivative of human blood.

Caution should be exercised when administering ABRAXANE concomitantly with known substrates or inhibitors of CYP2C8 and CYP3A4.

ABRAXANE therapy should not be administered to patients with metastatic breast cancer who have baseline neutrophil counts of less than 1,500 cells/mm3. It is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE. Patients should not be retreated with subsequent cycles of ABRAXANE until neutrophils recover to a level >1,500 cells/mm3 and platelets recover to a level >100,000 cells/mm3

In the case of severe neutropenia (<500 cells/mm3 for 7 days or more) during a course of ABRAXANE therapy, a dose reduction for subsequent courses is recommended.

Sensory neuropathy occurs frequently with ABRAXANE.

If grade 3 sensory neuropathy develops, treatment should be withheld until resolution to grade 1 or 2 followed by a dose reduction for all subsequent courses of ABRAXANE.

Severe cardiovascular events possibly related to single-agent ABRAXANE occurred in approximately 3% of patients in the randomized trial. These events included chest pain, cardiac arrest, supraventricular tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary embolism, and hypertension.

In the randomized metastatic breast cancer study, the most important adverse events included alopecia (90%), neutropenia (all cases 80%; severe 9%), sensory neuropathy (any symptoms 71%; severe 10%), asthenia (any 47%; severe 8%), myalgia/arthralgia (any 44%; severe 8%), anemia (all 33%; severe 1%), infections (24%), nausea (any 30%; severe 3%), vomiting (any 18%; severe 4%), diarrhea (any 27%; severe <1%), and mucositis (any 7%; severe <1%).

Other adverse reactions have included ocular/visual disturbances (any 13%; severe 1%), fluid retention (any 10%; severe 0%), hepatic dysfunction (elevations in bilirubin 7%, alkaline phosphatase 36%, AST [SGOT] 39%), renal dysfunction (any 11%; severe 1%), thrombocytopenia (any 2%; severe <1%), hypersensitivity reactions (any 4%; severe 0%), cardiovascular reactions (severe 3%), and injection site reactions (<1%). During postmarketing surveillance, rare occurrences of severe hypersensitivity reactions have been reported with ABRAXANE.

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Contacts:
Investors and Media Inquiries
Abraxis BioScience, Inc.
Maili Bergman, 310-405-7522

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