Healthcare Industry News:  NSCLC 

Biopharmaceuticals Oncology

 News Release - November 17, 2006

Study Reinforces Potential Utility of ONCONASE(R) in Non-Small-Cell Lung Cancer

Findings Presented at Joint Session of Radiation Research Society and American Society for Therapeutic Radiology and Oncology

BLOOMFIELD, N.J.--(HSMN NewsFeed)--Alfacell Corporation (NASDAQ: ACEL ) today announced the presentation of preclinical findings based on histological evidence and provide further support for the potential anti-tumor activity of ONCONASE® (ranpirnase) in non-small-cell lung cancer (NSCLC). The new data, which will help guide ongoing development of the NSCLC clinical program, demonstrated the following:
  • ONCONASE improved the efficacy of radiation therapy in vivo, resulting in significantly greater delay in tumor growth.

  • ONCONASE significantly induced apoptosis (programmed cell death) when administered as multiple low doses rather than when an equal dose was administered in a single injection. With proper hydration renal toxicity was not observed in these animals.

  • ONCONASE treatment was associated with significant decrease in lactic acid in tumors as well as increased tumor blood flow, suggesting the acute effect of ONCONASE may, in part, be due to its ability to reduce tumor interstitial fluid pressure (TIFP). TIFP is known to be a significant cause of inadequate drug delivery into solid tumors.

  • ONCONASE has promising therapeutic implications in cancer therapy because of its ability to induce apoptosis without suppressing the activity of functional p53, is a transcription factor that regulates the cell cycle and hence functions as a tumor suppressor. This is an important distinction between ONCONASE over other standard chemotherapeutic agents (DNA damaging agents).
"Based on our preclinical studies, we found ONCONASE to be effective against two resistant forms of NSCLC, EGFR-wild type and Iressa®-resistant forms. This was likely due to the significant increases in apoptosis observed in vivo and are further supported by the significantly reduced level of lactate, which may be an indicator of reductions in malignancy," said Dr. Lee. "We also learned that in addition to being effective, administering ONCONASE in multiple small doses allowed for manageable toxicity. This finding will help to guide clinical research with ONCONASE in NSCLC."

"These results suggest that ONCONASE may have a role as both an adjuvant to radiation and conventional chemotherapeutic agents in NSCLC," stated Dr. Kuslima Shogen, Chief Executive Officer of Alfacell. "Our phase I/II program with ONCONASE for the treatment of NSCLC is progressing and we look forward to presenting clinical findings in the near future."

These findings were presented during the 48th Annual Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO) and the 53rd Annual Meeting of the Radiation Research Society (RRS) in Philadelphia by Intae Lee, Ph.D., Department of Radiology, University of Pennsylvania Health System, Philadelphia. Some results from this study will be published in an upcoming issue of the journals "Anticancer Research" and "Advances in Experimental Medicine and Biology".

Summary of Results

In an in vitro study, ONCONASE alone inhibited cellular proliferation, induced apoptosis, and decreased tumor oxygen consumption. A549 NSCLC tumor cells were exposed to one of four doses of ONCONASE 24 hours prior to radiation. The two highest doses of ONCONASE significantly increased the cells' sensitivity to radiation. Exposure to ONCONASE also decreased the accumulation of damaged cells that retained the ability to repair themselves.

The effect of ONCONASE on radiation sensitivity was also studied in vivo in athymic nude mice. Mice received one of four treatments: control (saline and no radiation), ONCONASE alone, radiation plus saline, or radiation plus ONCONASE. The administration of ONCONASE prior to radiation significantly slowed tumor growth compared to radiation alone. The researchers observed significant increases in tumor blood flow without alteration in muscle blood flow.

About Non-Small Cell Lung Cancer (NSCLC)

According to the American Cancer Society, lung cancer is the leading cause of cancer deaths worldwide among men and women. NSCLC is the most common form of lung cancer, accounting for 80 percent of all lung cancer cases. In 2004, NSCLC accounted for approximately 160,000 deaths in the United States. According to industry analysts, the NSCLC drug market is projected to exceed $4 billion by 2012.

About ONCONASE®

ONCONASE is a first-in-class therapeutic from Alfacell's proprietary ribonuclease (RNase) technology platform. ONCONASE has been shown to target tumor cells while sparing normal cells. ONCONASE is internalized by endocytosis and released into the cytosol of the cancerous cell, where it selectively degrades tRNA beyond repair. In doing so, ONCONASE inhibits protein synthesis, stops cell cycle proliferation, and induces apoptosis (programmed cell death).

ONCONASE has previously been granted Orphan Drug designation from EMEA and TGA (Australia), as well as Fast Track status by the FDA. The Company is also conducting an ONCONASE Phase I / II trial in Non-Small Cell Lung Cancer (NSCLC).

About Alfacell Corporation

Alfacell Corporation is a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for cancer and other life-threatening diseases, using its proprietary ribonuclease (RNase) technology platform. For more information, please visit http://www.Alfacell.com.

Safe Harbor

This press release includes statements that may constitute "forward- looking" statements, usually containing the words "believe," "estimate," "project," "expect" or similar expressions. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, uncertainties involved in transitioning from concept to product, uncertainties involving the ability of the Company to finance research and development activities, potential challenges to or violations of patents, uncertainties regarding the outcome of clinical trials, the Company's ability to secure necessary approvals from regulatory agencies, dependence upon third-party vendors, and other risks discussed in the Company's periodic filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release.


Source: Alfacell

Issuer of this News Release is solely responsible for its content.
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