Nanotechnology Now - Press Release: Second Trial with ABRAXANE to Demonstrate Increased Survival in Patients with Advanced Pancreatic Cancer

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Abstract:
Single Agent ABRAXANE Shows Median Survival of Greater Than 7 Months in Patients Who Failed Gemcitabine Therapy

Second Trial with ABRAXANE to Demonstrate Increased Survival in Patients with Advanced Pancreatic Cancer

Los Angeles, CA | Posted on May 21st, 2010

Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, previously announced it will be presenting more than 30 studies, including new clinical data evaluating the use of nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable suspension; paclitaxel protein albumin-bound particles for injectable suspension) for the treatment of pancreatic cancer at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. A phase 2 clinical study evaluating nab-paclitaxel (100 mg/m2) in advanced pancreatic cancer patients who have progressed on gemcitabine-based therapy (Abstract #4120), treatment resulted in 58 percent of patients achieving six-month overall survival (OS), with a median survival of 7.3 months and a median progression-free survival (PFS) of 1.6 months. Five patients remain alive at a median follow-up of 12.7 months, including one patient with stable disease (SD) on cycle 15 of therapy. Complete trial results will be presented during a poster session on June 6 at 2 p.m. CT.

"The results of this study demonstrate that single agent nab-paclitaxel is active in pancreas cancer patients who have previously progressed on gemcitabine-based therapy," said Caio Max Rocha Lima, M.D., Associate Professor of Clinical Medicine, University of Miami Sylvester Comprehensive Cancer Center.

The pancreatic trial results follow recent findings from a phase 1/2 study of nab-paclitaxel in combination with gemcitabine, which demonstrated increased survival in first-line treatment of patients with advanced pancreatic cancer. Presented at the 101st Annual Meeting of the American Association for Cancer Research (AACR) in April 2010, median OS for 44 patients treated at the recommended dose of 125 mg/m2 nab-paclitaxel plus gemcitabine (1000 mg/m2) was 12.2 months, a doubling of survival compared to historical control of gemcitabine alone.i ABRAXANE has been granted orphan drug designation by the Food and Drug Administration for the treatment of pancreatic cancer as well as stage IIB-IV melanoma. Enrollment is ongoing for a phase 3 trial program evaluating nab-paclitaxel plus gemcitabine versus gemcitabine alone as a first-line therapy for advanced metastatic pancreatic cancer.

"The success of ABRAXANE in patients with pancreatic cancer supports our belief and understanding of how the nab-driven chemotherapy leverages the tumor biology against itself to increase efficacy," said Patrick Soon-Shiong, M.D., Executive Chairman and founder of Abraxis BioScience. "We believe ABRAXANE exploits the albumin-binding protein receptor, Gp60, to penetrate the blood-stroma barrier in essence opening a portal to the tumor micro-environment, enabling the delivery of targeted cytotoxic agents leading to stromal collapse and tumor penetration."

Pancreatic cancer can be particularly hard to treat because many patients are diagnosed after their disease has progressed. This year more than 42,000 people are expected to be diagnosed with pancreatic cancer in the United States and more than 35,000 people will die from the disease.ii Recent research indicates that an exceptionally dense stroma around pancreatic tumors contributes to treatment difficulty, and that delivery systems that can break through this surrounding mass may deliver more drug to the cells and improve outcomes.iii

About the Study

I. 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)

In this phase 2 study, 19 patients with advanced pancreatic cancer who had progressed on gemcitabine-based therapy and had an ECOG PS of 0-2 were treated. Therapy consisted of nab-paclitaxel (100 mg/m2) monotherapy over 30 minutes on days 1, 8, and 15 of a 28-day cycle. Primary endpoint was six-month OS; secondary endpoints were response rate based on RECIST criteria, PFS, safety and toxicity profile. Results included:

* Six-month OS of 58 percent and median OS of 7.3 months
* Median PFS was 1.6 months
* One patient with PR and six patients (32 percent) with SD as their best response. Five patients are alive with a median follow-up of 12.7 months, including one patient with SD on cycle 15 of therapy
* Twelve patients (63 percent) with progressive disease (PD) on or before the first response assessment. After two cycles, the median CA 19-9 level decreased by 52 percent in patients who had SD or PR, versus an 18 percent drop in patients with PD

Safety results were generally consistent with the known safety profile of nab-paclitaxel. Non-hematological toxicities were generally mild with grade 1 or 2 nausea (63 percent), anorexia (47 percent), hypocalcemia (37 percent) and vomiting (26 percent) observed. The most common grade 3 and 4 adverse events that occurred were neutropenia (32 percent), neutropenic fever (11 percent) and anemia (11 percent). There were no cases of grade 3 or 4 neuropathy. Nab-paclitaxel was well-tolerated and provided clinical benefit in 37 percent of patients who had previously progressed on gemcitabine-based therapy.

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.

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.

ABRAXANE 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.

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.

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i Gemzar [package insert]. Indianapolis, IN: Eli Lilly and Company; Revised 2010.
ii American Cancer Society. Cancer Facts & Figures 2009. Atlanta: American Cancer Society; 2009. Available at http://www.cancer.org/docroot/STT/STT_0.asp.

iii Ken Garber. Stromal Depletion Goes on Trial in Pancreatic Cancer. Journal of the National Cancer Institute. April 7, 2010, Volume 102, Issue 7, 448-450.

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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 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 www.abraxane.com.

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