The company recorded a net loss of approximately
Net loss for the fiscal year ended
Cash and Liquidity
As of
Clinical/Regulatory Update
Alfacell has completed patient enrollment in a confirmatory Phase IIIb clinical trial for ONCONASE in patients suffering from unresectable malignant mesothelioma (UMM) and reached the required number of evaluable events to conduct the formal statistical analyses required to complete the final sections of the ONCONASE rolling NDA. As the company has previously reported, the results of the preliminary statistical analysis of the data did not meet statistical significance for the primary endpoint of survival in UMM. However, a statistically significant improvement in survival was seen in the treatment of UMM patients who failed one prior chemotherapy regimen, a pre-defined primary data set for this sub-group of patients in the trial, which represents a currently unmet medical need. Alfacell has requested a pre-NDA meeting with the Food and Drug Administration (FDA) to discuss the details of the planned NDA submission. The company continues to estimate that the final components of the rolling NDA will be submitted by the end of 2008, and the company plans to present the results of the Phase IIIb trial at an upcoming scientific conference in 2009.
The company has completed enrollment in its Phase I clinical trials for patients suffering from non-small cell lung cancer (NSCLC) and other solid tumors and is planning for a follow-on Phase II clinical trial in NSCLC patients that exhibit resistance to platinum based chemotherapy regimens. Initiation of patient enrollment in this trial is currently expected to occur in early 2009.
"Fiscal 2008 was a year of progress at Alfacell," said
About ONCONASE(R)
ONCONASE is a first-in-class therapeutic product candidate based on Alfacell's proprietary ribonuclease (RNase) technology. A natural protein isolated from the leopard frog, ONCONASE has been shown in the laboratory and clinic to target cancer cells while sparing normal cells. ONCONASE triggers apoptosis, the natural death of cells, via multiple molecular mechanisms of action.
Alfacell has licensed the U.S. commercial rights for ONCONASE to Strativa Pharmaceuticals, a division of Par Pharmaceutical, Inc. Strategic marketing and distribution agreements for ONCONASE have been secured with Megapharm Ltd. for
ONCONASE has been granted fast track status and orphan-drug designation for the treatment of malignant mesothelioma by the FDA. Additionally, ONCONASE has been granted orphan-drug designation in the European Union and
About Alfacell Corporation
Alfacell Corporation is the first company to advance a biopharmaceutical product candidate that works in a manner similar to RNA interference (RNAi) through late-stage clinical trials. The product candidate, ONCONASE, is an RNase that overcomes the challenges of targeting RNA for therapeutic purposes while enabling the development of a new class of targeted therapies for cancer and other life-threatening diseases. In addition to a recently completed Phase IIIb study in malignant mesothelioma, Alfacell is currently planning for Phase II clinical trials in other oncology indications. For more information, visit 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, uncertainty whether the clinical trial results will allow the company to complete submission of a New Drug Application and if a New Drug Application submission is completed, uncertainty whether FDA will file or approve such application, 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 or differences of opinion in interpreting the results 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.
ALFACELL CORPORATION
Condensed Statements of Operations
Three-Months Ended Fiscal Year Ended July 31 July 31 2008 2007 2008 2007 Revenues $ -- $ -- $ -- $ -- Expenses: Research and development 2,148,839 1,247,601 8,503,110 5,543,175 General and administrative 765,112 1,248,385 5,797,355 4,092,990 Total expenses 2,913,951 2,495,986 14,300,465 9,636,165 Loss from operations (2,913,951) (2,495,986) (14,300,465) (9,636,165) Interest income, net 32,838 66,586 223,984 370,554 State tax benefit -- -- 1,755,380 510,467 Net loss $(2,881,113) $(2,429,400) $(12,321,101) $(8,755,144) Net loss per share - basic and diluted $ (0.06) $ (0.05) $ (0.26) $ (0.19) Shares used in computation of net loss per share: Basic and diluted 47,266,000 45,489,000 46,919,000 44,958,000
Balance Sheet Data:
July 31, July 31, 2008 2007 Cash and cash equivalents $ 4,661,656 $ 6,968,172 Total assets $ 5,320,036 $ 7,820,499 Current liabilities $ 2,882,034 $ 1,829,900 Accumulated deficit $(104,392,856) $(92,071,755) Total stockholders' equity (deficiency) $ (3,556,606) $ 5,778,480
Media and Investor Contact:
David Schull or Wendy Lau Russo Partners 212-845-4271 David.Schull@russopartnersllc.com Wendy.Lau@russopartnersllc.com
SOURCE Alfacell Corporation