Risikowert aber mit Potential gutes Portfolio - 500 Beiträge pro Seite

[Shanghai2006]

Fuer alle die sich etwas naeher mit Novogen beschaeftigen wollen. Hier die Homepage, sehr informativ, uebersichtlich und gut aufgemacht.
http://www.novogen.com/

Noch eine Statusuebersicht der Trails
http://www.novogen.com/contact/contact0701.cfm?mainsection=07&subsection=05

Novogen Produkte
http://www.novogen.com/consumer_health/index.html

Falls Ihr Fragen haben solltet, hier Investor Relation Kontakte
http://www.novogen.com/contact/contact0701.cfm?mainsection=07&subsection=02

Ich bin investiert und bleibe investiert fuer die naechsten 10Jahre.

Fuer alle Anderen wuensche ich eine gute Zeit mit Novogen.

[Shanghai2006]

NEW CANAAN, CT--(Marketwire - 01/21/10) - The Board of Directors of Marshall Edwards, Inc. today advised that analysis of tumor response data from the OVATURE trial will be performed in the second quarter of 2010, after the database is locked and the data are subjected to independent review by the Tumor Response Evaluation Committee.

While initial data collection from all sites is now complete the Company is currently working through a number of outstanding routine data queries that remain to be addressed by some trial sites prior to database lock. Consideration had been given to undertake a preliminary analysis of the primary endpoint (Progression Free Survival) based on investigator assessments of radiological scans by site personnel prior to final data base lock. After consideration of regulatory advice provided to the Board, it was decided to preserve the integrity of the study for regulatory review and not perform any endpoint analysis prior to database lock.

The OVATURE protocol specifies that tumor response analysis be performed on independent Tumor Response Evaluation Committee assessment of radiological evidence, and this cannot be performed until after database lock has been achieved. The Board has decided to avoid potentially compromising the data from the OVATURE trial by completing an analysis of the primary efficacy endpoint of progression free survival based on assessments of radiological scans by site personnel, which have not been verified by the independent Tumor Response Evaluation Committee. Further, there is a risk that site interpretation of radiological scans may be at variance with independent assessments, and could result in conflicting outcomes.

Alan Husband, Group Director of Research, stated: "Performing an analysis of progression free survival based on assessments of radiological scans by site personnel, that have not been verified by the independent Tumor Response Evaluation Committee could potentially compromise the integrity of the study data."

The Company expects the final analysis will be performed strictly according to the protocol and now is expected to be completed in the second quarter of 2010.

About the OVATURE trial

The OVATURE trial is a major multi-center international Phase III clinical trial of orally-administered investigational drug phenoxodiol in combination with carboplatin in women with advanced ovarian cancer resistant or refractory to platinum-based drugs, to determine its safety and effectiveness when used in combination with carboplatin.

The OVATURE trial recruited ovarian cancer patients whose cancer initially responded to chemotherapy, but had since become resistant or refractory to traditional platinum treatments. The protocol provided for an analysis of interim results after 95 of the planned 340 recruited patients experienced disease progression. Enrollment of new study subjects was terminated in April 2009 at which time 142 patients had been randomized to the study. The Special Protocol Assessment (SPA) that had been approved by the U.S. Food and Drug Administration (FDA) was inactivated coincident with premature termination of enrollment.

Changes in standards of care over the period the trial and the specific inclusion/exclusion criteria of the OVATURE protocol had slowed patient recruitment rates and, consequently, the Company deemed it prudent not to fund the trial to completion as originally planned. In addition, the downturn in global financial markets experienced at that time would have made it difficult to raise further equity or debt to fund the trial through to completion. The Independent Data Monitoring Committee ("IDMC") supported the Company's decision to close the study to accrual, and, in a review of the available safety data, the IDMC confirmed that there were no safety concerns with phenoxodiol in these subjects.

About phenoxodiol:

Phenoxodiol is being developed as a chemosensitizing agent in combination with platinum drugs for late stage, chemoresistant ovarian cancer and as a monotherapy for prostate and cervical cancers. It is believed to have a unique mechanism of action, binding to cancer cells via a cell membrane oxidase, causing major downstream disturbances in expression of proteins necessary for cancer cell survival and responsible for the development of drug resistance.

In cancer cells, phenoxodiol appears to selectively inhibit the regulator known as S-1-P (sphingosine-1-phosphate) that is overexpressed in cancer cells. In response to phenoxodiol, the S-1-P content in cancer cells is decreased, with a consequent decrease in expression of the pro-survival proteins XIAP and FLIP, inducing cancer cell death via caspase expression and promoting sensitivity to other chemotherapeutics. Indeed, in laboratory studies, it has been demonstrated that drug-resistant ovarian cancer cells pre-treated with phenoxodiol were killed with lower doses of chemotherapy drugs.

Importantly, phenoxodiol has been shown not to adversely affect normal cells in animal and laboratory testing.

Phenoxodiol has received Fast Track status from the FDA to facilitate its development as a therapy for recurrent ovarian and prostate cancers.

Phenoxodiol is an investigational drug and, as such, is not commercially available. Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by FDA as being safe and effective for the intended use.

About Marshall Edwards, Inc.:

Marshall Edwards, Inc. (NASDAQ:MSHL - News) is a specialist oncology company focused on the clinical development of novel anti-cancer therapeutics. These derive from a flavonoid technology platform, which has generated a number of novel compounds characterized by broad ranging activity against a range of cancer cell types with few side effects. The combination of anti-tumor cell activity and low toxicity is believed to be a result of the ability of these compounds to target an enzyme present in the cell membrane of cancer cells, thereby inhibiting the production of pro-survival proteins within the cell. Marshall Edwards, Inc. has licensed rights from Novogen Limited (ASX:NRT - News) (NASDAQ:NVGN - News) to bring four oncology drugs -- phenoxodiol, triphendiol, NV-143 and NV-128 -- to market globally.

Marshall Edwards, Inc. is majority owned by Novogen, an Australian biotechnology company that is specializing in the development of therapeutics based on a flavonoid technology platform. More information on phenoxodiol and on the Novogen group of companies can be found at www.marshalledwardsinc.com and www.novogen.com.

Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties in clinical trial results; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.

Here the official link:
http://finance.yahoo.com/news/Analysis-of-Marshall-Edwards-i…

[Shanghai2006]

Annual Income till June2008
http://finance.yahoo.com/q/is?s=nvgn&annual

[Shanghai2006]

Comments from Graham Kelly (Jan 22, 2010) announcement.

First, the negatives.

(a) It is both frustrating and disappointing that the release of any analytical data is delayed yet again. This is the third postponement. I don’t think that it would be asking too much that the current senior management and Chairman get off their collective behinds and get out into shareholder land and face the market and explain what is going on. I don’t doubt that the reasons are all perfectly reasonable and valid, but investors deserve a lot more than a series of excuses by way of stock exchange releases. Directors who don’t have a significant proportion of their life-savings or pension plans tied up in the stock, and who go on drawing salaries regardless, can afford to have a sanguine view of the world. That could easily be fixed by paying directors in share options – watch the improvement in public relations then.

If I was still in the Chair, I would be calling shareholder briefing meetings in a number of sites in the US as well as Sydney and London. I would be as open and frank as stock exchange rules allow, I would seek to reassure shareholders and to answer questions and I would give a realistic future time-line.

(b) This latest problem goes to the heart of the longer-term problem with OVATURE … the appointment of a CRO that severely under-performed. That is a decision that can be squarely laid at the feet of current management. Any pivotal study can expect to have outstanding data issues that need tidying up. But the tidying up in this case seems to be more than a trivial matter, and that is something that good auditing by the Company of the CRO’s performance on an ongoing basis would have uncovered much earlier.

Having got that off my chest, now to the positives.

(a) The reasons for the delay look perfectly valid. The Tumor Response Evaluation Committee has made a certain recommendation and a Sponsor would be foolish to ignore that advice, particularly as it goes to the validity of the primary end-point. There is always the risk of variance in the interpretation of scans between a site and the independent reviewer. Site reviewers are not in every case highly experienced in RECIST determination of progression of ovarian cancers. Readers can easily acquaint themselves with the RECIST criteria, suffice to say that it involves measuring the longest diameters of all identifiable tumour masses, as well as determining the presence of any new tumours. Where there is a large number of tumours per scan, and/or some degree of lack of definition in the scan, then interpretations can vary. The Committee wants to have any variations between the site and the independent reviewer sorted out before the data is analysed. That seems perfectly sensible to me.

(b) My bet is that the FDA is still very much on-side with this trial and with what Novogen is trying to achieve. That view is based on a number of studies held with the FDA re OVATURE over a number of years. I would further bet that the delay is in accordance with the FDA’s advice.

(c) I really can’t see anyone going to all this trouble if the outcome looked futile.

Original link: http://boards.fool.com/message.asp?source=isesitlnk0000001&m…