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NRT may have 'turned the corner' last night on the Nasdaq with NVGN showing a modest gain in a lack lustre market. This update (stock report) from Westport Capital may have helped in some way or, another.

 

Text of Westport NVGN Update 05/05/2004

 

Westport Capital Markets, LLC

Email Update for Clients

Novogen, Ltd. ADR (NVGN)

May 5, 2004

 

 

Dear Clients:

 

Considerable progress has been made in the development of NovogenÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s lead anti-cancer agent, phenoxodiol, since our last Email Update (March 16, 2004):

 

ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¢ Four abstracts providing additional evidence of phenoxodiolÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s tumor-killing and anti-cancer effects in preclinical studies and clinical trials were presented at the 95th Annual Meeting of the American Association of Cancer Research (AACR) in Orlando, FL, on March 27-31.

ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¢ NovogenÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s subsidiary, Marshall Edwards,Inc., commenced a multicenter clinical trial that will evaluate the ability of phenoxodiol to restore the sensitivity of ovarian cancer to paclitaxel and cisplatin.

ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¢ Novogen was awarded a 5-year, $10 million research and development grant by the Australian Government.

 

The recent developments at Novogen strengthens our confidence that the company has the talent and resources to bring the clinical development of phenoxodiol to a successful conclusion.

 

AACR Presentations

 

The results of two preclinical studies and two clinical trials were presented at AACR.

 

One preclinical study extended the data presented at the 35th Annual Meeting of the Society of Gynecologic Oncologists (SGO) that we reviewed in our March 9, 2004, Investment Research Report.

At SGO, Yale researchers convincingly demonstrated that phenoxodiol restores sensitivity of several chemoresistant ovarian cancer cell lines to carboplatin and paclitaxel and that this effect is mediated by stimulation of programmed cell death (apoptosis) due to inhibition of XIAP and the activation of several caspases. At AACR, the same Yale researchers showed that phenoxodiol shifts the dose-response curves of carboplatin, paclitaxel, and gemcitabine in killing several ovarian cancer cell lines in culture by 30- to over 100-fold. In mouse tumor xenografts, phenoxodiol significantly potentiated the tumor-killing effects of these drugs.

 

The other preclinical study was of particular importance because it was conducted by a laboratory at the National Institutes of Health (NIH) that had not previously reported on phenoxodiol. Dr. Adrian SenderowiczÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s laboratory demonstrated that phenoxodiol has a strong antiproliferative effect on head and neck squamous and salivary gland carcinoma cell lines. Specifically, phenoxodiol appears to arrest cell division by upregulating the expression of a protein called p21. Dr. Senderowicz also showed that the arrested cells then undergo apoptosis. He is currently investigating how phenoxodiol upregulates p21 and is evaluating the anti-tumor efficacay of phenoxodiol in head and neck cancer models. We consider the addition of such a reputable researcher to the family of investigators who

have demonstrated potent anti-tumor effects of phenoxodiol to be significant development. Dr. Senderowicz provides independent confirmation of phenoxodiolÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s tumor-killing activity and he does it in yet another type of cancer.

 

Yale researchers provided additional data on the phase Ib/II clinical trial of patients with recurrent ovarian cancer that are resistant to second-line chemotherapy. Preliminary results of this trial, presented at SGO, showed a 25% disease stabilization rate and an interesting observation that 8 of 9 paclitaxel-resistant patients responded with a decrease in their CA125 levels to re-challenge with another round of paclitaxel therapy after completing their phenoxodiol treatment. At AACR, we learned that 8 of 10 patients who were treated with a taxane after phenoxodiol had a marked serologic response ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã‚¡ÃƒÆ’‚¬Ãƒâ€Â¦ÃƒÆ’¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã¢â‚¬Å“ an average 64% decrease in their CA125 levels. Five of these patients were considered

taxane-sensitive (meaning they had been treated only once with a taxane and they responded, only to have the cancer recur later) and five were documented as being taxane resistant or refractory (meaning taxanes were ineffective). Four of five patients in each of these groups responded to re-challenge with taxane. Moreover, we learned that all of these patients, at the time of the AACR meeting, were still alive and being treated by standard chemotherapy over one year following phenoxodiol treatment. Yale researchers are currently imaging some of these patients to determine if their tumor mass has decreased.

 

In an exciting development, Novogen had an abstract accepted into a ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¦ÃƒƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“Late-breakingÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ poster session. Dr. Graham Kelly, a founder and current Executive Director of Novogen, presented the results of a phase Ib/IIa clinical trial of oral phenoxodiol in patients with late-stage, hormone-refractory prostate cancer. This was a dose-ranging safety and efficacy trial, 6 patients in each dose group. Patients were to be treated for three cycles of 21 days of treatment then 7 days without treatment (16 weeks in total) or until disease progression. The results are presented in the table below:

 

Disease Response

(% decline in PSA levels)

Dose (3 times/day) Disease Progression Disease Stabilization 25-50% 50-75%

 

20 mg 4 2 0 0

80 mg 4 2 0 0

200 mg 2 1 3 0

400 mg 2 1 1 2

 

Importantly, no drug-associated toxicities were reported and phenoxodiol was well-tolerated. A dose-response effect was observed, with 6 of 12 men in the two highest dose levels showing marked

declines in blood levels of prostate-specific antigen (PSA). These patients have now been treated for up to 24 weeks. Novogen plans to initiate a new clinical trial of phenoxodiol in combination with standard taxane or platinum chemotherapy in men with late-stage, hormone-refractory prostate cancer.

 

Initiation of Second Ovarian Cancer Clinical Trial

 

On April 21, Novogen and Marshall Edwards confirmed that another clinical trial of phenoxodiol in patients with recurrent, late-stage ovarian cancer began enrolling patients. This trial differs from the first in that this one will evaluate phenoxodiol in combination with paclitaxel or cisplatin. All preclinical data indicates that phenoxodiol is an effective chemosensitizer that restores the ability of taxanes and platinum-based drugs to kill tumors. The FDA has also indicated that combination therapy is the faster path to drug approval. Moreover, we observed at AACR that there is a clear trend by clinical investigators to evaluate various existing and experimental drugs in combination for the

treatment of any cancer. There is an emerging view that it will be far more effective to treat cancer, like HIV and heart failure, with a ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¦ÃƒƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“cocktailÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ of drugs that target different cellular pathways that contribute to disease progression.

 

This phase II clinical trial will enroll 60 patients at Yale-New Haven Hospital and at an as yet

undetermined site in Australia. Patients will be documented as being refractory to taxane-based and/or platinum-based drugs and will have failed 1-4 prior chemotherapy regimens. In Part 1 of this trial, patients will be treated every week for 6 weeks (maximum of 12 weeks) with phenoxodiol (by injection) on two consecutive days followed by single injection of paclitaxel or cisplatin. This is the ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¦ÃƒƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“run-inÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ phase of the trial, designed to establish an acceptable, minimally toxic dose of the combination of paclitaxel or cisplatin and phenoxodiol. Importantly, this is the standard therapy for ovarian cancer as recommended by the Gynecologic Oncology Group (GOG), a non-profit, National Cancer Institute (NCI supported organization that promotes excellence in the quality and integrity of clinical and basic research in gynecologic cancers. Once the dose of paclitaxel or cisplatin is

established, patients will enter Part 2 of the trial, the efficacy phase. In Part 2, the 6-week treatment cycles will be repeated until a response is obtained (or there is disease progression). However, it is possible that some patients may respond to this treatment while in Part 1 of the trial. Yale researchers believe that the chemosensitizing effect of phenoxodiol will enable the dose of these agents to be significantly reduced without affecting their tumor-killing ability.

 

The primary endpoints are (1) reduction in tumor mass, (2) blood levels of the tumor markers CA125 and CA19.9, (3) improvement in clinical status, and (4) 6- and 12-month survival. This will be the first clinical trial of phenoxodiol designed to measure survival, the Holy Grail of all anti-cancer drugs in development. Since this clinical trial adheres strictly to GOG criteria, the survival of patients in this trial will be able to be compared to patients treated with paclitaxel or cisplatin alone at other clinics. All patients will be matched by age, stage of cancer, and number of failed treatment regimens. Yale also expects to enroll patients in a parallel control arm who will not be treated with phenoxodiol.

 

Several recently FDA-approved anti-cancer drugs have not shown a survival benefit in clinical trials, including ImCloneÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s ErbituxÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã‚¡ÃƒÆ’‚¬Ãƒâ€Â¦ÃƒÆ’‚¾ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¢ (cetuximab) and AstraZenecaÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s IressaÃÆâ€â„¢ÃƒÆ’ƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚® (geritinib). Demonstration of a survival benefit, even a brief prolongation of survival, can have a profound effect on a stockÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s value. Witness the recent doubling in the value of OSI PharmaceuticalsÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢ (Nasdaq:OSIP) stock in response to a small survival benefit (estimated to be 2-3 months) in patients with relapsed non-small cell lung cancer following treatment with their anti-cancer drug, TarcevaÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã‚¡ÃƒÆ’‚¬Ãƒâ€Â¦ÃƒÆ’‚¾ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¢ (erlotinib).

 

$10 Million Australian Government Grant

 

On April 26, 2004, the Australian GovernmentÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s Department of Industry awarded Novogen A$10 million in research and development funding under its Pharmaceutical Partnerships Program. This is a 5-year grant. Novogen announced that it will use the funds to accelerate development of phenoxodiol, as well as to advance other compounds in the companyÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s pipeline.

 

Looking Ahead

 

We anticipate that this year will be pivotal for Novogen and its subsidiary, Marshall Edwards. We learned at AACR that Novogen is establishing additional preclinical and clinical research agreements with several investigators who are interested in evaluating phenoxodiol and related compounds in NovogenÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s pipeline. Dr. Senderowicz is one of several investigators who have expressed interest in working with Novogen to explore the anti-cancer effects of the companyÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s drugs. In the next several months, we expect Novogen will announce the start of other clinical trials of phenoxodiol in a variety

of cancers. Preliminary results from the new clinical trial just started at Yale may become known sometime this summer, particularly if a robust clinical response is observed.

 

Please call if you have any questions.

 

George B. Zavoico, Ph.D., and Steven J. Knapp

 

Westport Capital Markets, LLC

183 Main Street

Westport, CT 06880

Tel: 203-227-5610

 

 

Cheers

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LC

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NRT may have 'turned the corner' last night on the Nasdaq with NVGN showing a modest gain in a lack lustre market. This update (stock report) from Westport Capital may have helped in some way or, another.

 

Text of Westport NVGN Update 05/05/2004

 

Westport Capital Markets, LLC

Email Update for Clients

Novogen, Ltd. ADR (NVGN)

May 5, 2004

 

 

Dear Clients:

 

Considerable progress has been made in the development of NovogenÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s lead anti-cancer agent, phenoxodiol, since our last Email Update (March 16, 2004):

 

ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¢ Four abstracts providing additional evidence of phenoxodiolÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s tumor-killing and anti-cancer effects in preclinical studies and clinical trials were presented at the 95th Annual Meeting of the American Association of Cancer Research (AACR) in Orlando, FL, on March 27-31.

ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¢ NovogenÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s subsidiary, Marshall Edwards,Inc., commenced a multicenter clinical trial that will evaluate the ability of phenoxodiol to restore the sensitivity of ovarian cancer to paclitaxel and cisplatin.

ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¢ Novogen was awarded a 5-year, $10 million research and development grant by the Australian Government.

 

The recent developments at Novogen strengthens our confidence that the company has the talent and resources to bring the clinical development of phenoxodiol to a successful conclusion.

 

AACR Presentations

 

The results of two preclinical studies and two clinical trials were presented at AACR.

 

One preclinical study extended the data presented at the 35th Annual Meeting of the Society of Gynecologic Oncologists (SGO) that we reviewed in our March 9, 2004, Investment Research Report.

 

At SGO, Yale researchers convincingly demonstrated that phenoxodiol restores sensitivity of several chemoresistant ovarian cancer cell lines to carboplatin and paclitaxel and that this effect is mediated by stimulation of programmed cell death (apoptosis) due to inhibition of XIAP and the activation of several caspases. At AACR, the same Yale researchers showed that phenoxodiol shifts the dose-response curves of carboplatin, paclitaxel, and gemcitabine in killing several ovarian cancer cell lines in culture by 30- to over 100-fold. In mouse tumor xenografts, phenoxodiol significantly potentiated the tumor-killing effects of these drugs.

 

The other preclinical study was of particular importance because it was conducted by a laboratory at the National Institutes of Health (NIH) that had not previously reported on phenoxodiol. Dr. Adrian SenderowiczÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s laboratory demonstrated that phenoxodiol has a strong antiproliferative effect on head and neck squamous and salivary gland carcinoma cell lines. Specifically, phenoxodiol appears to arrest cell division by upregulating the expression of a protein called p21. Dr. Senderowicz also showed that the arrested cells then undergo apoptosis. He is currently investigating how phenoxodiol upregulates p21 and is evaluating the anti-tumor efficacay of phenoxodiol in head and neck cancer models. We consider the addition of such a reputable researcher to the family of investigators who

have demonstrated potent anti-tumor effects of phenoxodiol to be significant development. Dr. Senderowicz provides independent confirmation of phenoxodiolÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s tumor-killing activity and he does it in yet another type of cancer.

 

Yale researchers provided additional data on the phase Ib/II clinical trial of patients with recurrent ovarian cancer that are resistant to second-line chemotherapy. Preliminary results of this trial, presented at SGO, showed a 25% disease stabilization rate and an interesting observation that 8 of 9 paclitaxel-resistant patients responded with a decrease in their CA125 levels to re-challenge with another round of paclitaxel therapy after completing their phenoxodiol treatment. At AACR, we learned that 8 of 10 patients who were treated with a taxane after phenoxodiol had a marked serologic response ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã‚¡ÃƒÆ’‚¬Ãƒâ€Â¦ÃƒÆ’¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã¢â‚¬Å“ an average 64% decrease in their CA125 levels. Five of these patients were considered

taxane-sensitive (meaning they had been treated only once with a taxane and they responded, only to have the cancer recur later) and five were documented as being taxane resistant or refractory (meaning taxanes were ineffective). Four of five patients in each of these groups responded to re-challenge with taxane. Moreover, we learned that all of these patients, at the time of the AACR meeting, were still alive and being treated by standard chemotherapy over one year following phenoxodiol treatment. Yale researchers are currently imaging some of these patients to determine if their tumor mass has decreased.

 

In an exciting development, Novogen had an abstract accepted into a ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¦ÃƒƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“Late-breakingÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ poster session. Dr. Graham Kelly, a founder and current Executive Director of Novogen, presented the results of a phase Ib/IIa clinical trial of oral phenoxodiol in patients with late-stage, hormone-refractory prostate cancer. This was a dose-ranging safety and efficacy trial, 6 patients in each dose group. Patients were to be treated for three cycles of 21 days of treatment then 7 days without treatment (16 weeks in total) or until disease progression. The results are presented in the table below:

 

Disease Response

(% decline in PSA levels)

Dose (3 times/day) Disease Progression Disease Stabilization 25-50% 50-75%

 

20 mg 4 2 0 0

80 mg 4 2 0 0

200 mg 2 1 3 0

400 mg 2 1 1 2

 

Importantly, no drug-associated toxicities were reported and phenoxodiol was well-tolerated. A dose-response effect was observed, with 6 of 12 men in the two highest dose levels showing marked declines in blood levels of prostate-specific antigen (PSA). These patients have now been treated for up to 24 weeks. Novogen plans to initiate a new clinical trial of phenoxodiol in combination with standard taxane or platinum chemotherapy in men with late-stage, hormone-refractory prostate cancer.

 

Initiation of Second Ovarian Cancer Clinical Trial

 

On April 21, Novogen and Marshall Edwards confirmed that another clinical trial of phenoxodiol in patients with recurrent, late-stage ovarian cancer began enrolling patients. This trial differs from the first in that this one will evaluate phenoxodiol in combination with paclitaxel or cisplatin. All preclinical data indicates that phenoxodiol is an effective chemosensitizer that restores the ability of taxanes and platinum-based drugs to kill tumors. The FDA has also indicated that combination therapy is the faster path to drug approval. Moreover, we observed at AACR that there is a clear trend by clinical investigators to evaluate various existing and experimental drugs in combination for the

treatment of any cancer. There is an emerging view that it will be far more effective to treat cancer, like HIV and heart failure, with a ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¦ÃƒƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“cocktailÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ of drugs that target different cellular pathways that contribute to disease progression.

 

This phase II clinical trial will enroll 60 patients at Yale-New Haven Hospital and at an as yet

undetermined site in Australia. Patients will be documented as being refractory to taxane-based and/or platinum-based drugs and will have failed 1-4 prior chemotherapy regimens. In Part 1 of this trial, patients will be treated every week for 6 weeks (maximum of 12 weeks) with phenoxodiol (by injection) on two consecutive days followed by single injection of paclitaxel or cisplatin. This is the ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¦ÃƒƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“run-inÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ phase of the trial, designed to establish an acceptable, minimally toxic dose of the combination of paclitaxel or cisplatin and phenoxodiol. Importantly, this is the standard therapy for ovarian cancer as recommended by the Gynecologic Oncology Group (GOG), a non-profit, National Cancer Institute (NCI supported organization that promotes excellence in the quality and integrity of clinical and basic research in gynecologic cancers. Once the dose of paclitaxel or cisplatin is

established, patients will enter Part 2 of the trial, the efficacy phase. In Part 2, the 6-week treatment cycles will be repeated until a response is obtained (or there is disease progression). However, it is possible that some patients may respond to this treatment while in Part 1 of the trial. Yale researchers believe that the chemosensitizing effect of phenoxodiol will enable the dose of these agents to be significantly reduced without affecting their tumor-killing ability.

 

The primary endpoints are (1) reduction in tumor mass, (2) blood levels of the tumor markers CA125 and CA19.9, (3) improvement in clinical status, and (4) 6- and 12-month survival. This will be the first clinical trial of phenoxodiol designed to measure survival, the Holy Grail of all anti-cancer drugs in development. Since this clinical trial adheres strictly to GOG criteria, the survival of patients in this trial will be able to be compared to patients treated with paclitaxel or cisplatin alone at other clinics. All patients will be matched by age, stage of cancer, and number of failed treatment regimens. Yale also expects to enroll patients in a parallel control arm who will not be treated with phenoxodiol.

 

Several recently FDA-approved anti-cancer drugs have not shown a survival benefit in clinical trials, including ImCloneÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s ErbituxÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã‚¡ÃƒÆ’‚¬Ãƒâ€Â¦ÃƒÆ’‚¾ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¢ (cetuximab) and AstraZenecaÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s IressaÃÆâ€â„¢ÃƒÆ’ƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚® (geritinib). Demonstration of a survival benefit, even a brief prolongation of survival, can have a profound effect on a stockÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s value. Witness the recent doubling in the value of OSI PharmaceuticalsÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢ (Nasdaq:OSIP) stock in response to a small survival benefit (estimated to be 2-3 months) in patients with relapsed non-small cell lung cancer following treatment with their anti-cancer drug, TarcevaÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€¦Ã‚¡ÃƒÆ’‚¬Ãƒâ€Â¦ÃƒÆ’‚¾ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚¢ (erlotinib).

 

$10 Million Australian Government Grant

 

On April 26, 2004, the Australian GovernmentÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s Department of Industry awarded Novogen A$10 million in research and development funding under its Pharmaceutical Partnerships Program. This is a 5-year grant. Novogen announced that it will use the funds to accelerate development of phenoxodiol, as well as to advance other compounds in the companyÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s pipeline.

 

Looking Ahead

 

We anticipate that this year will be pivotal for Novogen and its subsidiary, Marshall Edwards. We learned at AACR that Novogen is establishing additional preclinical and clinical research agreements with several investigators who are interested in evaluating phenoxodiol and related compounds in NovogenÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s pipeline. Dr. Senderowicz is one of several investigators who have expressed interest in working with Novogen to explore the anti-cancer effects of the companyÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s drugs. In the next several months, we expect Novogen will announce the start of other clinical trials of phenoxodiol in a variety

of cancers. Preliminary results from the new clinical trial just started at Yale may become known sometime this summer, particularly if a robust clinical response is observed.

 

Please call if you have any questions.

 

George B. Zavoico, Ph.D., and Steven J. Knapp

 

Westport Capital Markets, LLC

183 Main Street

Westport, CT 06880

Tel: 203-227-5610

 

 

Cheers

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QUOTE
ASX MEDIA RELEASE
12 MAY 2004
NOVOGENÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢S SECOND ANTI-CANCER DRUG ENTERS HUMAN CLINICAL TRIALS

(Sydney Australia) - Novogen has commenced a human clinical trial of a new patented anti-cancer compound, NV-18.

NV-18 is derived from phenoxodiol, the CompanyÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s first anti-cancer drug that is now producing data in human clinical trials for the treatment of late-stage ovarian and prostate carcinomas.

NV-18 has been approved for a Phase Ia study at St George Hospital in Sydney, Australia. 

The study will determine the drugÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s bio-availability, pharmacokinetic profile, and acute safety.
The drug will be administered in three different ways:

ÃÆâ€â„¢ÃƒÆ’ƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚· orally;
ÃÆâ€â„¢ÃƒÆ’ƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚· by bolus intravenous injection; and
ÃÆâ€â„¢ÃƒÆ’ƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚· by slow intravenous infusion over four hours.

All of these modes of delivery will be administered to 6 patients with solid tumours and will be conducted over a trial period of 8 weeks.

NV-18 is a product of the Novogen diphenolic synthetic analogue program that is creating drugs with diverse activities against specific types of cancer. Like phenoxodiol, NV-18 is broadly effectivein the laboratory against almost all human cancer types, but NV-18 is distinctive in showingparticular potency against melanoma and cholangiocarcinoma (cancer of the gall-bladder).

In laboratory studies conducted in collaboration with researchers at the University of Newcastle (Australia) and the University of Alabama at Birmingham (USA), NV-18 has proven highly effective at killing both melanoma cells and cholangiocarcinoma cells, cancers that are typically highlyresistant to standard anti-cancer drugs.

Novogen proposes to evaluate the ability of NV-18 to act as an effective monotherapy against these two cancer types.  However, it is anticipated that its primary role will be to act as a chemo-sensitiser for standard anticancer agents.

Novogen scientists, in pre-clinical studies, have shown that NV-18 is particularly effective as a chemo-sensitising agent, rendering chemo-resistant melanoma cells highly susceptible to the killing effect of standard anti-cancer drugs such as taxanes.

Chemo-sensitisation is a new direction for anti-cancer therapy.

Various cancers, such as cancers of the prostate, kidney and cervix, are relatively insensitive to chemo-toxic drugs from the start, while others, such as cancers of the ovary and breast, eventually become insensitive after showing initial responsiveness.

A number of mechanisms within the cancer cell lead to such inherent or acquired resistance and it now is recognised that overcoming these mechanisms is a logical and achievable objective in the treatment of cancer.

In preclinical studies, NV-18, like phenoxodiol, is able to overcome and reverse those resistance mechanisms, rendering cancer cells susceptible to standard anti-cancer drugs including those based on the taxane and platinum structures that are highly effective at killing cancer cells.

The planned clinical development program for NV-18 will focus firstly on malignant melanoma, a cancer that is characterised by being poorly responsive to standard anti-cancer drugs and having a poor prognosis once it has metastasized.

Novogen has entered into a licence option with a Marshall Edwards Inc (Nasdaq: MSHL) company.

This option grants to Marshall Edwards the first right to accept and the last right to match any proposed dealing by Novogen with its intellectual property rights relating to certain synthetic pharmaceutical compounds, including this compound, NV-18. Marshall Edwards Inc is currently 87 per cent owned by Novogen Limited.

Currently Novogen has biological response modifying compounds undergoing development in the areas of cancer, cardio-vascular, skin repair, anti-inflammatory and wound healing.

The lead anti-cancer drug, phenoxodiol, which is licensed to Marshall Edwards, is being clinically trialled as a stand-alone therapy and as a chemo-sensitising agent to strengthen or reactivate existing cancer treatments.

Novogen is advancing clinical development of its compounds to a point where it can maximize shareholder value through out-licensing.

Novogen has developed a patented suite of intellectual property around its technology platform and is co-ordinating its international research and clinical development programs in collaboration with some of the worldÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s leading medical research centres.

More information on the Novogen group of companies and their associated technology developments can be found at www.novogen.com and at www.marshalledwardsinc.com.

ISSUED FOR : NOVOGEN LIMITED
LISTINGS : ASX (CODE NRT), NASDAQ (CODE NVGN).

FOR FURTHER MR CHRISTOPHER NAUGHTON, MANAGING DIRECTOR, NOVOGEN LIMITED
INFORMATION : TEL (02) 9878 0088 http://www.novogen.com

ISSUED BY : WESTBROOK COMMUNICATIONS
CONTACT: DAVID REID TEL (02) 9231 0922 OR 0417 217 157
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