BLOOMFIELD, N.J., Jan. 30 /PRNewswire-FirstCall/ -- Alfacell Corporation today provided the following update on the Company’s international, confirmatory Phase IIIb trial evaluating ONCONASE(R) (ranpirnase), the Company’s lead investigational drug candidate, as a treatment for unresectable malignant mesothelioma (UMM):
* The Company expects to reach full enrollment of 316 patients for the trial ahead of the previously announced timeframe of end of First Quarter 2006. * In addition, as a result of the Fast Track designation granted to ONCONASE for the UMM indication by the FDA, the Company plans to pursue expedited regulatory review of the New Drug Application (NDA) upon filing. Under the FDA Modernization Act of 1997, the Fast Track designation provides for expedited review for new drugs demonstrating the potential to address unmet medical needs for the treatment of serious or life-threatening conditions.
“We are pleased to announce this favorable revision of our previous guidance,” stated Kuslima Shogen, Chief Executive Officer of Alfacell. “The success of our clinical and regulatory strategies for the ONCONASE UMM program further illustrates Alfacell’s ongoing commitment to accelerate the regulatory path required to bring ONCONASE to market.”
About Alfacell Corporation
Alfacell Corporation is a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for cancer, using its proprietary RNase technology platform. ONCONASE(R) (ranpirnase), Alfacell’s lead investigational drug candidate, is currently being evaluated in several studies, including a Phase IIIb registration study for malignant mesothelioma (MM) and a Phase I / II trial in Non-Small Cell Lung Cancer (NSCLC). For more information, please visit http://www.alfacell.com.
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.
Contact: Alfacell Corporation: Investor/Media Relations: Kuslima Shogen Elite Financial Communications Robert Love Dodi Handy (973) 748-8082 (407) 585-1080 info@alfacell.comacel@efcg.net
Alfacell Corporation
CONTACT: Kuslima Shogen, or Robert Love, both of Alfacell Corporation,+1-973-748-8082, info@alfacell.com; or Investor/Media Relations - DodiHandy, of Elite Financial Communications, +1-407-585-1080, acel@efcg.net
Web site: http://www.alfacell.com/