Forum Archive Index - November 2002

["G Stolwyk" <stolwyk@wave.co.nz>]

PART 1: Results and Marketing.

Sofar NRT has a winner in NV07-a, previously referred to. Apparently it is better than any product on the market. One exclusive International Conference to discuss this product has been held and there is another one to come.

Prof. Alan Husband is in charge of the work associated with this and will front any conferences. Is NV07-a big? Yes, it will be. A massive market awaits this product and I believe that in 2003, agreements will be signed with the largest Cosmetic companies.
No approval from the FDA is needed.

The expected royalties and milestone payments together with the $40 mill. cash in hand will pay for NRT Trials for years to come, in my opinion. (The Phenoxodiol trials are financed by "Marshall Edwards INC or MEI and NRT holds 95%).

Then we have the OTC (over the counter products). These concern the very good seller Promensil, Rimostil and Trinovin.
The coming Patents in Dec? for Promensil will shake the existing market which infringes this Patent.

Further trials are being held particularly with Promensil, the only clinically approved drug which gives relief from Menopause symptoms.

One notices that although NRT has other promising drugs in the pipeline, NV07-a, could greatly increase the share price once Announcements re marketing are made. On its own, it could be big enough to support NRT.

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PART 2: Further Achievements and Trials.

There are 2 companies:
1. Marshall Edwards Inc. or MEI, 95% owned by the Parent company Novogen or NRT. The latter sold 5% for $US 10 mill. and this is used to conduct clinical trials of Phenoxodiol (Pheno). MEI has the license to commercialize this drug , once approved by the FDA. The Patents which run out in 2016, are being held by NRT.

Briefly, tumours may consist of different colonies-are polyclonal- with different growth receptors. An STI or Single Transduction Inhibitor may therefore affect one set of growth receptors and causing those cells to die but not others.
Pheno will kill all cancer cells in the laboratory and is called an MSTR or Multiple Signal Transduction Regulator. (The next best drug only killed 60% of cancer cells).

Dr Kelly, the Chairman of MEI mentioned that about half of cancers have inactivated their death receptors and therefore will not die. Pheno has the ability to re-activate the death receptors in a potent manner and this in turn leads to self destruction of the cancer cell.

Pheno is highly selective and will only attack cancer cells, is non-toxic while side effects are very small or non existent. This in turn will shorten trials-or more trials can be conducted-while it is quite possible to acquire concessions from the FDA leading to early marketing.

These concessions comprise several expressions which are not discussed here. It is clear that Pheno-derived drugs' trials save money compared with those of different drugs.

Pheno does not need to kill all the cancers in these clinical trials. A 20% kill is very good and even if life can be extended by a certain amount of time, that in itself can be grounds for approval by the FDA.

Yale university thinks that the effect of Pheno on a cancer in a clinical trial would be noticeable within a week. About a week ago, Leukemia trials started in the RNS Hospital, Sydney. However, protocol demands that there will be no discussion of results till after the completion of the trial. Other clinical trials will be conducted in the USA and in Europe. Leukemias, Ovarian-, breast-cervical- and pancreas cancers will be subjected to Pheno.

There will be 2 sets of Phase II trials: A: Pheno stand alone; this to finish at the end of Dec/Jan and B: A cocktail consisting of Pheno and Cisplatin, a generic drug. The latter to finish in June 2003. (The combination drug increases the number of death receptors even faster).

2. Novogen or NRT. This company produces drugs and except for Phenoxodiol, holds at present the following drugs:
NV04, a very promising cardio. drug:
http://www.ozestock.com.au/News.asp?Action=ShowAnnouncement&ArticleID=215358

NV07A Already discussed in Part 1.
NV07B: Anti-inflammatory drug to combat RA and inflammatory bowel disease.
NV47: Drug to attack select tumours.
NV050: Drug to combat breast cancer.
NV5063, a di-mer and powerful drug still to be trialled against breast cancer.
P-07: Under development: a menopause drug-no data.
P082: Under development - Male cholestorol drug.

Trials are continuously being conducted. NRT can and will produce further powerful drugs. On 30 June, NRT had $40 mill. cash-See also PART 1.

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PART 3: Phenoxodiol Trials, Potential and Share price.

 

1. Intravenous and oral administration.

When Pheno is taken by mouth then, when travelling through the gut, the Pheno molecules become coated with sugars. Unless these are removed, the drug cannot be accessed.

 

Only the Breast and Prostate produce enzymes which will remove this coating and hence Pheno by mouth can be taken in these 2 cases only. Intravenous injection is needed in all other cancers.

 

2. Type of Patient  nominated for these trials: patients already having had 2 different failed treatments and in many cases only have a few months to live.

 

3. List of Trials.

On 20 Nov. Phase II trials on 6 diferent forms of Leukemia started in the RNSH, Sydney.

- Two more Phase II trials are set to start this month, one on Ovarian
cancer (Yale Uni) and the other in cervical cancer. Early 2003 will see the
commencement of Phase II trials for Renal cancer, Pancreatic cancer and
Breast cancer (oral form); a phase I/II trial for Prostate cancer using Oral Pheno commenced Aug. 2002.

All cancers except Breast and Prostate will be in the A/B mode: Trial A  will use Pheno only and this will be followed by Trial B: Pheno + Cisplatin.

 

4. NOVOGEN develops powerful drugs:

A large number of analogues of phenoxodiol have been synthesized.
These are compounds based on the phenoxodiol structure, but modified
to varying degrees. The effect of that structural modification is to
produce new drugs with different anti- cancer effects compared to
phenoxodiol. Of particular interest is the finding that it is
possible to produce drugs with specific activity against specific
types of cancer. This is an entirely novel and exciting finding,
pointing to the ability of Novogen scientists to customize drugs for
specific cancer types.

 

5.  Potential.

PART 1 discussed NV07-a and this shows much promise. The trials using Phenoxodiol will of course be most interesting. Should there be acceptable results in only a couple of diseases, then the share price could rocket. A satisfactory answer to Breast cancer alone will be sufficient.

 

As mentioned,  lengtening of personal lives can be sufficient to attract approval from the FDA: people will live with their disease; that already happens with Prostate cancer patients.

 

6.Mentioning possible share prices is counter productive, particularly as the outcomes from the Trials are not certain.  The Chairman of MEI, dr Kelly holds 10% of Novogen.

 

7. Material from this series sourced from:

 

http://www.ozestock.com.au/messageview.asp?symbol=NRT&PostNum=2029&POSTNUMBER=true

 

NRT Website: http://www.novogen.com/

 

Gerry

Disclaimer: Readers are not asked to buy, hold or sell NRT or NVGN. To do so will be at their own risk.