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American BioScience, Inc. Release: Key To Improved Chemotherapy Response To ABRAXANE(TM) Validated By Clinical Data


11/3/2005 11:25:00 AM

SANTA MONICA, Calif., Nov. 3 /PRNewswire/ -- American BioScience, Inc. (ABI) today presented clinical data at the Chemotherapy Foundation Symposium XXIII on several studies of ABRAXANE, including non-small cell lung cancer, metastatic malignant melanoma and head and neck cancer, showing high response rates in a variety of tumors that typically respond poorly to chemotherapy. The presentations were made in New York, November 2-5, 2005.

Patrick Soon-Shiong, founder and Executive Chairman of American Pharmaceutical Partners and founder, Chairman and CEO of ABI, said, "A body of research has established that a common denominator in breast, lung, ovarian, head and neck, melanoma, gastric, esophageal, glioma and cervical tumors that are difficult to treat is the secretion of a protein called SPARC. In addition to playing a role in allowing tumors to spread, we discovered that SPARC also attracts albumin-bound nutrients to nourish the tumor as it grows and spreads. Exploiting this tumor's attraction for albumin, we were able to turn conventional targeted chemotherapy on its head. Instead of the drug targeting the tumor, the tumor targets the albumin-bound drug.

"We developed a chemotherapeutic cloaked in a nanometer-sized particle of albumin, which is approximately 1/100th the size of a single red blood cell. Millions of these particles are injected in a single dose of medication. This albumin-bound medication enters the bloodstream where it is transported across the blood vessel wall via a receptor, and targeted by SPARC secreted from the tumor cell.

"In essence what we are doing is tricking the tumor into killing itself as it seeks out albumin-bound nutrients, using SPARC as the magnet to attract the albumin. The significance of this insight is that it appears that SPARC is secreted by almost all solid tumors tested to date. We are currently exploring the nab(TM) technology platform in many of these tumor types using a multitude of active chemotherapeutic agents. Our plans are to continue this effort across the cancer spectrum."

Neil Desai, Ph.D., Vice President of Research and Development at ABI, said, "In clinical studies of ABRAXANE, we are now seeing significant response rates in a variety of tumors that typically respond poorly to chemotherapy. The emerging data are consistent with what we discovered about SPARC and we believe -- pending further study -- correlate with the high rates of response that we are seeing in these cancers."

ABRAXANE: Head and Neck Cancer

Michael Hawkins, M.D., Chief Medical Officer, ABI, presenting data to the Chemotherapy Foundation Symposium XXIII on SPARC expression and response to ABRAXANE in Head and Neck Cancers, Nov. 3, 11:30 a.m., EST.

Previous reports have documented a high response rate in patients with head and neck cancers who have been treated with ABRAXANE. Data will be presented documenting that tumors from many of the responding patients with head and neck cancers exhibited poor prognostic markers, including mutations of p53 tumor suppressor gene and over-expression of SPARC.

"These data are the first clinical evidence that ABRAXANE's antitumor activity may be enhanced in patients whose tumors accumulate albumin through SPARC binding and are exciting because they suggest that the high rates of response are due to activity against tumors that have not typically responded to chemotherapy in the past," said Michael Hawkins, M.D.

ABRAXANE: Advanced Non-small Cell Lung Cancer

Naiyer Rizvi, M.D., Assistant Attending Physician and Principal Investigator, Memorial Sloan-Kettering Cancer Center, presenting data from his Phase I/II Study of ABRAXANE in Chemotherapy-naive, Advanced Non-small Cell Lung Cancer to the Chemotherapy Foundation Symposium XXIII on Nov. 4, 10:35 a.m., EST.

Interim results from a Phase I/II study of ABRAXANE as weekly, first-line therapy in chemotherapy-naive patients with Stage IV non-small cell lung cancer (NSCLC) indicated it showed a high degree of antitumor activity. Of the 41 patients in the study treated with ABRAXANE 125 mg/m2 on days 1, 8 and 15 every 28 days, 34 have been evaluated for tumor response. Patient responses included one confirmed complete response (CR), seven confirmed partial responses (PR), and four partial responses awaiting confirmation (response rate 35%).

ABRAXANE: Metastatic Malignant Melanoma

Evan M. Hersh, M.D., Professor of Medicine, Head, Melanoma Program, Arizona Cancer Center, Tucson, AZ, presenting data from his Open-Label, Multicenter, Phase II trial of ABRAXANE in Previously Treated and Chemotherapy-naive Patients with Metastatic Malignant Melanoma to the Chemotherapy Foundation Symposium XXIII on Nov. 4, 2:45 pm EST.

Results from a Phase II clinical study of weekly ABRAXANE indicated it was well-tolerated and resulted in both remissions and stable disease in excess of four months in patients with metastatic malignant melanoma.

The open-label, multicenter Phase II trial was designed to evaluate ABRAXANE administered weekly for three weeks via 30-minute IV infusion followed by one week of rest, without premedication, in chemotherapy-naive (CN) (150mg/m2) and previously treated (PT) (100 mg/m2) patients with measurable metastatic malignant melanoma. The study enrolled 74 patients (n=37 CN patients; n=37 PT patients). As expected, antitumor activity was greatest in the CN patients: 10 of 37 (27%) CN patients responded and an additional eight had stable disease for at least 16 weeks (disease control rate 49%). Median time to tumor progression was more than five months, approximately three times longer than what has commonly been reported for DTIC (a chemotherapy drug approved for the treatment of malignant melanoma). As expected, the activity of ABRAXANE was less in PT patients. However, even in this group the disease control rate was greater than 38% and the time to tumor progression was 3.5 months.

SPARC is recognized as being associated with a poor prognosis in malignant melanoma. "I have been treating patients with metastatic malignant melanoma for many years and ABRAXANE is the most active single agent I have encountered for the treatment of this disease in clinical trials," said Evan Hersh, M.D., the principal investigator of the study. "We are currently in the process of obtaining samples from patients who have been treated in this study to determine if SPARC expression in these tumors may explain the high degree of antitumor activity we are seeing."

The U.S. Food and Drug Administration approved ABRAXANE(TM) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in January 2005. ABRAXANE currently is indicated 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(TM) please visit www.abraxane.com.

About American BioScience, Inc.

American BioScience, Inc. (ABI) is a privately held biotechnology company focused on the discovery, development and delivery of next-generation therapeutic moieties including biologically active molecules already existing within the human biological system, for the treatment of life-threatening diseases. ABI owns a majority interest in American Pharmaceutical Partners, Inc.

About American Pharmaceutical Partners

American Pharmaceutical Partners, Inc. is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets. Abraxis Oncology, the proprietary division of APP, is devoted entirely to developing and promoting innovative, next-generation cancer therapies such as ABRAXANE(TM), recently launched for the treatment of metastatic breast cancer. For more information, visit APP's website at www.appdrugs.com and www.abraxisoncology.com.

Because these forward-looking statements, whether expressed or implied, 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 timing of and costs associated with the ongoing launch of ABRAXANE(TM), the market adoption and demand of ABRAXANE, the fact that actual results achieved in further Phase II and III trials for ABRAXANE may or may not be consistent with results achieved to date, the difficulty in predicting the timing or outcome of other product research and development efforts, potential product characteristics and indications, marketing approvals and launches of other products, 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, the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in American Pharmaceutical Partner's Form 10-K for the year ended December 31, 2004 and other documents filed by us with the Securities and Exchange Commission.

Contacts: Rob Whetstone/Robert Jaffe

PondelWilkinson Inc. (310) 279-5963

American BioScience, Inc.

CONTACT: Rob Whetstone or Robert Jaffe, both of PondelWilkinson Inc.,+1-310-279-5963, for American BioScience, Inc.



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