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Alfacell Provides Shareholder Update

June 19, 2009

SOMERSET, N.J., June 19 /PRNewswire-FirstCall/ —

Dear Shareholder,

I am grateful to have this opportunity to share with you important developments taking place at this critical juncture in our company history. This communication shall mark what I hope will be the first of many as your president.

Like many of you, I also have been a longtime shareholder and supporter of this company. I want you to know I am fully committed no matter how difficult the challenge, to see this company and our valuable compounds realize their full potential.

As you are aware, we did not meet our primary endpoint of overall survival in our Phase IIIb clinical trial in patients suffering from unresectable malignant mesothelioma (UMM). We did however; achieve statistical significance with a subgroup of patients who failed a prior chemo therapy. Overall survival was 10.5 months for this group. As we reported in January 2009, we had a pre-NDA meeting with the FDA and the FDA provided guidance to the company recommending that an additional trial be conducted in UMM patients that have failed at least one prior chemotherapy regimen prior to submitting an NDA. Considering Onconase’s overall safety profile, its ability to overcome MDR, I believe that Onconase remains a viable candidate for second line therapy in MM.

The fact that Onconase was able to extend the lives of patients who had failed a prior chemo therapy was not lost in our thoughts. About a year ago, we engaged Champions Biotechnology, to conduct a series of animal studies on immune deficient mice to see what effect Onconase would have on human tumors grafted onto these mice. Tumorgrafts parallel sensitivity and resistance in the clinic. The results showed Onconase has a documented synergistic effect in Cisplatin sensitive and resistant NSCLC. We are not surprised by these results and believe Onconase has the potential to overcome multiple drug resistance (MDR). A publication regarding this study is in the process of being completed.

To quote Zbigniew Darzynkiewicz, M.D., Ph.D. Professor of Pathology and Medicine; Director, Brander Cancer Research Institute, New York Medical College, a long time collaborator who has published numerous peer reviewed articles regarding the molecular mechanism of Onconase states the following: “We now have compelling evidence from numerous preclinical studies including investigations on animals that Onconase strongly enhances effect of many types of anticancer drugs. The enhancement of the anticancer effectiveness by Onconase was shown to involve prevention of the induction defense mechanism which generally are triggered by the anticancer drugs and provide resistance to treatment. This propensity of Onconase makes it an attractive candidate to be used as an adjunct to variety of cancer treatment protocols. In this capacity Onconase can be widely used in therapy of different tumor types, including most common types such as cancer of breast, prostate, colon, ovary and lung.”

Another quote is provided by Harvey I. Pass. Director, New York University Medical Center, Division of Thoracic Surgery; Chief of Thoracic Oncology: “The promising subgroup analysis requested by the FDA exhibiting a significant survival advantage for those individuals previously treated with chemotherapy who received the combination of Onconase and doxorubicin points to molecular mechanisms of inherent or acquired chemotherapy resistance. It is known that there are specific chemotherapy resistance genes which not only are present in untreated mesotheliomas but also become over expressed when certain chemotherapeutic agents, including platinum, are used in the first line therapy of cancer. These genes, known as the multidrug resistance (MDR) gene1 and the multidrug resistance associated protein gene make proteins which act like pumps to keep chemotherapy out of the cells, so anything that will interfere with this function may allow more drug to come into the cells and cause death of the cancer. Another major master controller gene known as nfkB is also known to be elevated when normal cells turn into mesothelioma cells, and high levels of this gene have been associated with resistance to chemotherapy. In order to investigate whether Onconase specifically targets these three genes, we added Onconase to three mesothelioma cell lines at a dose which is achievable in humans, and then using molecular biology techniques including polymerase chain reaction, measured the levels of the MDR and nfkB genes after treatment with the drug. Striking decreases in all of these genes in the mesothelioma cell lines were seen after treatment with Onconase validating the hypothesis that one of the mechanisms of action of Onconase is to decrease resistance to chemotherapy. Moreover, these data in cell lines are complemented by most recent animal study in mice bearing tumors of varying sensitivity to Cisplatin and Carbo Platinum. In all of the animal models, the addition of Onconase to Cisplatin significantly increased the tumor growth inhibition compared to Cisplatin or Onconase alone, and in the tumor model most resistant to platinum, Onconase addition to platinum increased tumor growth inhibition from 37% to 73%. These in vitro and in vivo data, which are presently being prepared for publication emphasize the uniqueness of Onconase in its ability to directly modulate chemotherapy sensitivity, and mandate a trial in non-small cell lung cancer to prospectively demonstrate increased tumor responses when Onconase is added to a standard lung cancer chemotherapy regimen.” Another independent study in vivo is underway that may confirm Dr. Pass’ in vitro study.

After much thought, consideration, and input from highly respected lung experts, we have decided our path moving forward would be to conduct a clinical trial in non small cell lung cancer (NSCLC) in patients who have become resistant to platinum therapy. Dr. David Sidransky (Alfacell Chairman of the Board) is spearheading this effort and is in the process of finalizing a special protocol assessment (SPA) which will be presented to the FDA. The patients will be evaluated radiologically for tumor response and will also be evaluated for the time to tumor progression, survival, and side effects of treatment.

Today, other important scientific developments are underway. We are investigating ways to generate revenue from our compounds outside of the clinical and regulatory arena. One such experiment we are looking into is whether Onconase can be used as routine tool to detect the gene silencing via RNA interference (RNAi) mechanism. Currently, there are thousands of researchers interested in finding the answer about the RNAi-mediated gene regulation using their gene of interest. Should we be able to get a positive result, researches from all over the world could be potential buyers of Onconase. We anticipate results shortly.

Other studies will be conducted in order to elucidate if Onconase is able to down regulate the protein produced by the MDR1 gene. There is ample evidence this may be the case, and if so, as previously mentioned, Onconase would be a strong candidate to be used as an adjunct to other chemo therapy regimes.

Of course, our ability to continue with these efforts will depend on our ability to obtain additional financing in the near-term. Talks have been ongoing with potential private investors regarding recapitalizing the company. We cannot assure you, however, that we will be able to secure the necessary financing to maintain the company’s operations and pursue these worthwhile projects. It is my sincere hope investors and shareholders alike will see the value in our compounds and continue supporting the company. As I stated earlier, I am totally committed to our future success. I believe we have a unique opportunity to make a noticeable impact in the field of oncology giving those patients debilitated by these dreadful cancers the opportunity to live meaningful lives while we continue to find better therapies and one day a permanent cure for cancer.

Sincerely,

Charles Muniz

President, Chief Operating Officer

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.

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. 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.

    Media and Investor Contact:
    Charles Muniz
    Alfacell Corporation
    732-652-4525
    info@alfacell.com

SOURCE Alfacell Corporation


Source: newswire



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