|
Chairman's address to the annual meeting of shareholders
Ladies and Gentlemen,
Welcome to the Marshall Edwards Inc Annual Stockholders Meeting. My name is Bryan Williams, and I am the Chairman of the Board of Directors of your Company.
Before we move to the formal motions to be put to the meeting, I would like to make some comments on the current state of the Company, highlight some of our advances and reinforce our strategy for commercialization.
Following the formal part of the meeting, our interim CEO David Seaton will address further matters of strategy and management, and our Group Director of Research, Professor Alan Husband, will update us on the status of the analysis of the Ovature trial and the clinical and preclinical programs which we are conducting.
The business model of Marshall Edwards Inc is to in-license clinical stage oncology drugs based on the isoflavone derivative scaffold; to bring them through the clinical stages of development; and complete the preclinical evidence and manufacturing methodologies necessary for product registration. We will then out-license the drugs to larger companies.
In our current year we have focused on the Ovature trial and on our licensing program taking into account the uncertainties in the capital markets. Although the market has shown positive trends, the biotechnology industry is still in a difficult position. This is because most of the cash being moved back into equity has largely not targeted biotechnology. This challenging position led us to conclude that the likelihood of raising sufficient capital to complete the Ovature trial was very low. The other major factor influencing this decision was that the changes in standards of care that had taken place since the trial had commenced had continued to have a negative impact on recruitment into the trial. In particular the patient inclusion criteria for Overture was deemed to be too rigid in this changed patient treatment environment. This led to the likely timeline to complete recruitment becoming unacceptable both from a commercial and medical stand point. Accordingly, we made the decision on April 14, 2009 to suspend further recruitment into the trial.
Professor Alan Husband will address the Ovature program that is now in place to complete the final analysis of the data from the 142 patients who entered the trial.
To extend the use of our cash reserves and focus these on those areas with the best chance of early licensing we also instituted a 20 percent reduction in fees and income for all the Board and executive management. Management has also undergone a change with Mr Chris Naughton ceasing his employment as CEO of our parent company Novogen and of Marshall Edwards on December 1, 2009. The companys CFO, Mr. David Seaton, has been appointed acting CEO of both Novogen and Marshall Edwards and will continue in that role until a new CEO for Marshall Edwards has been appointed. We are presently conducting an international search using a highly reputable search firm to identify Mr. Naughtons successor and are seeking an individual with drug development and clinical oncology experience together with a track record of fund raising in the US capital markets.
I would like to take this opportunity to thank Mr Naughton for his contributions to Marshall Edwards since its inception 9 years ago and wish him well in his future endeavors. As I stated above , the focus of Marshall Edwards remains clearly in the oncology drug development space and because of the high priority we give our current and future clinical programs, the Board considers the appointment of a new CEO dedicated to Marshall Edwards is paramount to implementing our strategy.
Despite the serious economic downturn and continuing uncertainty in the markets we have stayed on track with respect to our operational plan and I would like to highlight some of the progress we have reported since our last AGM. Professor Husband will expand on some of the details.
Phenoxodiol remains a very interesting compound. A phase II study in prostate cancer showed that it was very well tolerated and we reported in July that it had the ability to kill rapidly proliferating T cells suggesting an investigation into its efficacy for treating diseases driven by T-cell proliferation such as certain leukemias is warranted.
We reported that we had been granted an IND for Triphendiol and this was subsequently supported by excellent safety profile data. An expert committee of GI oncologists was convened in October to consider the appropriateness of a clinical trial following up on the IND and enthusiastically supported this action.
Finally we have completed a license agreement with Novogen for NV-128. This compound has an excellent safety profile together with significant anti cancer activity in vivo in the very important and underserved area of non-small cell lung cancer. Importantly, we have established that the mode of action of this compound is as an mTOR inhibitor. However, this mode of action can be distinguished from most other members of this class of inhibitors by the fact that NV-128 inhibits both the TORC1 and TORC2 pathways. The majority of mTOR inhibiting compounds from large pharmaceutical companies, currently in clinical trials, inhibit only one of the mTOR pathways. Professor Husband will provide some further insight into this very exciting compound.
As I have stated previously the oversight of research programs and the strategic development of the Company is ultimately the Boards responsibility. I have been your Chairman now for over three years and I am pleased to attest that the Boards competence and enthusiasm continues to be a great asset of the Company. My continued experience in oncology research and management of pre-clinical developments and early clinical trials in my current position in Melbourne give me an early view of competing drug candidates. I believe that the niche occupied by our portfolio of compounds at Marshall Edwards and their unique mechanisms of action and low toxicity profiles equals or exceeds any other potential oncology candidates at similar stages of development.
In addition to the scientific and clinical backgrounds of myself and Professor Nestel and the pharmaceutical industry experience of Mr. Johnston has been augmented this year by the US biotechnology analyst experience of our US based director Ms Leah Cann. I thank Mr. Bill Rueckert for his service to the MEI Board and am pleased that we will continue to benefit, albeit indirectly, from his expertise with his appointment to the Novogen Board. We continue to consider the make up and expertise of the Board keeping in mind that further engagement in clinical trials requires additional expertise either in the form of Board members or expert committee advice.
I am confidant that the careful management of Mr. David Seaton will allow a smooth transition of the Company to a team led by a new CEO who will bring the skill set I have already outlined.
2009 has been a challenging year for MEI and I would like to take this opportunity to thank all the staff of both MEI and our parent company Novogen for all their efforts in discovery, preclinical and clinical development and management.
Thank you for your continued interest and support of Marshall Edwards.
Bryan Williams
Chairman
<<< back
|