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post Posted: Aug 29 2020, 08:52 AM
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In Reply To: macduffy's post @ Jun 13 2015, 06:40 AM

Five years since a post .... but, reading this about the most common form of brain cancer, it shows just how hard these cancers are to treat. I had a friend who died of glioblastoma this year; the last 18 months, from diagnosis to passing, was terrible for him.

With A 'Ticket To Ride', Kazia Wows Investors With Its Rare-Cancer Story
By Tim Boreham
As the political schisms in the US widen there's one element that does not discriminate between the major parties: the most common form of brain cancer. Known as glioblastoma, the condition claimed the life of Beau Biden, son of Democrat Oval Office aspirant Joe Biden. It also killed former Republican presidential candidate John McCain.

In the US, more than 13,000 Americans will receive a glioblastama diagnosis this year, with the disease accounting for about half of all primary malignant brain tumors. Sufferers can expect to live for only 12 to 15 months after diagnosis, with a five year chance of survival of less than 5 per cent.

Enter the ASX and Nasdaq listed Kazia Therapeutics, which has been trialling its lead drug paxalisib (formerly GDC0084) to treat the aggressive and complex disease. Paxalisib inhibits a signalling pathway called PI3K which is expressed in 85 per cent to 90 per cent of glioblastoma tumours.

After years of quiet development, Kazia in August achieved two key milestones.

On August 7 the company announced the US Food & Drug Administration had awarded the company a rare paediatric disease designation (RPDD) to treat Diffuse Intrinsic Pontine Glioma (DIPG).

DIPG is another rare and aggressive brain cancer, with a survival rate of less than one per cent. Annually it affects around 400 children in the US and 40 here, typically between the ages of four and 11. The average survival from diagnosis is around 9 to 10 months, says Kazia CEO Dr James Garner. This is the absolute definition of unmet medical need.

The paediatric news was followed swiftly by the August 20 revelation that the FDA had granted fast track designation for paxalisib in relation to glioblastoma. Fast track status is designed to expedite development of pharmaceutical products which demonstrate the potential to address unmet medical needs in serious or life threatening conditions.

A glioblastoma treatment currently exists, the generic drug temozolomide. Administered after surgery or radiotherapy) it's effective in only one-third of cases with a 'methylated' form of the condition. The remainder are 'unmethylated', the difference being the genetic makeup of the tumors.

Investors have latched on to the double dose of good news, with Kazia shares almost doubling since the start of August, on elevated volumes. While the company's Nasdaq listed equivalent shares have accounted for most of the activity in the past, recent trading has been locally oriented. Our quietest day in the last few months would have been our busiest day a year ago, Dr Garner says.There's definitely a sense the Australian market is waking up to the stock and not before time.

At least part of the $45 million valuation uplift relates to the 'rare paediatric disease priority review voucher' (PRV) that's attached to the RPDD.

Awarded on approval of the drug, PRVs are tradeable assets that have changed hands between $US68 million ($94m) and $US350m. More recently the values have converged to $US150-200m.

A review voucher shortens the FDA review period for a future marketing application of any drug from 12 months to six months. But it's most relevant for more advanced stage developers; hence the fungibility. If you can launch a $1 billion a year drug six months earlier it is worth half a billion dollars, Dr Garner says. The idea is not so much we use it but sell it to someone else.

The "cleverly designed" PRV scheme is scheduled to end in September and maybe extended depending on who wins the keys to the White House. At the very least there will be a hiatus with the issue of these vouchers and perhaps eventually there will be no more of them, Dr Garner says.

While the vouchers have a clear market value, the fast-track status given to glioblastoma program arguably is no less valuable, despite being less tangible.

The fast-track designation confers a number of benefits over the more snail-paced route, such as face-to-face meetings with the regulator. Post new drug application an expedited review may result in faster approval, with fast-track applications likely to be more successful.

It is like flying on a business class ticket rather than economy, Dr Garner says. We get a lot of extra support from the FDA and a quicker turnaround in many steps of the review process. Rather than submitting all documents at the end of development, it can be done over time and discussed and signed off as needed.

Despite the fast-lane benefits, any drug candidate needs to be supported by data proving its genuine potential. We could not be going for fast track designation in athlete's foot; there is no evidence the drug works for that, Dr Garner quips.

Kazia's next step in proving up paxalisib's efficacy is a so called pivotal clinical trial, designed directly to support a regulatory application.

Interim results from a phase II study showed paxalisib provided five months' median extension in patients' overall survival (they lived longer) and three months extension for progression free survival (the tumors did not get bigger).

Kazia is taking an unusual approach to the phase III (pivotal) trial, by joining a global study called GBM Agile. (GBM is shorthand for glioblastoma).

Created independently of any individual drug company, GBM Agile seeks to standardise the clinical approach and undertake joint research, thus reducing costs and producing data in a format the FDA prefers to see.

Paxalisib will be the second drug to join the study, behind a Bayer candidate called Stivarga (regorafenib). We expect to have up to 200 patients and roughly the same number of control group patients, Dr Garner says. We hope to start the study by the end of this year. ....That will take a couple of years to run its course but at the end of that we hope to got to regulatory agencies like FDA and obtain a marketing authorisation.

Kazia, meanwhile, is in a sound financial position, having 'beaten the rush" by raising $7.8 million in an oversubscribed placement in April. This was followed by a $1.8 million share purchase plan. We have money well into next year at this stage. We are in the nice position that we are not under pressure to do anything, Dr Garner says. After all, it's still a very uncertain market. The coronavirus isn't going away in a hurry, we have the US presidential election and some of the implications of the pandemic are yet to register.

After years of effort to build the credentials of paxalisib, an endgame is in sight for Kazia and its patient shareholders.

"Every long-term security is nothing more than a claim on some expected future stream of cash that will be delivered into the hands of investors over time. For a given stream of expected future cash payments, the higher the price investors pay today for that stream of cash, the lower the long-term return they will achieve on their investment over time." - Dr John Hussman

"If I had even the slightest grasp upon my own faculties, I would not make essays, I would make decisions." ― Michel de Montaigne

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post Posted: Jun 13 2015, 06:40 AM
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What NRT is about - an introduction.

post Posted: Mar 30 2015, 11:16 AM
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In Reply To: nicknack's post @ Mar 13 2015, 07:53 AM

SHARES in drug discoverer Novogen have surged after the company said its experimental anti-cancer drug Cantrixil killed human ovarian stem cells.

NOVOGEN, which is listed on the Australian Securities Exchange and the Nasdaq index in the United States, said studies had shown the drug had been highly effective in both in-vitro and animal studies.

The drug killed cells that are usually highly resistant to cytotoxic drugs and which are believed to be responsible for diseases recurring after initial therapy. Human trials of Cantrixil are expected to start in late 2015. The study will mainly target ovarian cancer and colo-rectal cancer.

"Every long-term security is nothing more than a claim on some expected future stream of cash that will be delivered into the hands of investors over time. For a given stream of expected future cash payments, the higher the price investors pay today for that stream of cash, the lower the long-term return they will achieve on their investment over time." - Dr John Hussman

"If I had even the slightest grasp upon my own faculties, I would not make essays, I would make decisions." ― Michel de Montaigne
post Posted: Mar 13 2015, 07:53 AM
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In Reply To: kennowaylass's post @ Feb 6 2015, 01:30 PM

I have been quietly acccumulating a fair sized holding with an average cost of 12.3c.It would have been easy to have traded the last three pump and dumps but my greatest fear is that I would be left behind as this stock, to my mind ,has the ability to skyrocket due it's dual listing status. NRT is currently displaying signs of serious accumulation and holding well at the 16/18c level. We may see a catalyic point when Cantrixil data is presented online to the AACR.

post Posted: Feb 6 2015, 01:30 PM
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In Reply To: kennowaylass's post @ Feb 3 2015, 10:11 PM

Novogen to present at BIO & CEO Investor Conference 9th &
10th February, 2015
New York, NY: Novogen Limited (ASX:NRT; NASDAQ:NVGN) is pleased to
announce that Novogen Group CEO and Executive Chairman, Graham Kelly PhD, will
be presenting at the 17th annual BIO CEO and Investor Conference being held on the
9th & 10th February, 2015.
The conference is the largest of its kind, focusing on established and emerging
publicly listed biotech companies and is attended by a mix of investors, analysts,
investment bankers and industry.
Dr Kelly will outline the Company’s two proprietary drug technology platforms and
their potential therapeutic value in oncology, as well as reviewing the Company’s
clinical strategy and timetable and anticipated milestones.
Kelly, said, “The BIO CEO and Investor conference presents an opportunity for
Novogen to bring its unique story to the attention of the market. Novogen is different.
The path we have chosen to take is different because current standard and
experimental approaches are failing to address the causes of cancer recurrence: the
impregnability of the cancer stem cell and the ability of a cancer to survive by
continuing to mutate and produce means of beating new therapies.”
“With one technology platform with a potent ability to kill cancer stem cells and a
second platform that produces dramatic synergy of some of the most widely used and
effective cytotoxics in chemotherapy, we believe we have the potential to make
meaningful differences to the lives of patients with malignant cancers.”
Date & Time: 9th February, 2015, 9am
Venue: The Waldorf Astoria, New York,
4th Floor, Duke of Windsor Room
About the Bio CEO & Investor Conference
The 17th Annual BIO CEO & Investor Conference is the largest independent investor
conference focused on publicly-traded biotechnology companies. The conference is
designed to foster an informative dialogue between institutional investors and senior
biotechnology executives about emerging and current investment opportunities. The
2014 CEO & Investor Conference featured 1,820 partnering meetings, 149 company
presentations, and 1,400 attendees, over half of which were investors.

post Posted: Feb 3 2015, 10:11 PM
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Ahhhhhh, the old NRT, I like what I am hearing lately from this company and would like some views from others. I have bought again after trading it a few years ago. This time I am not trading, just going to hang in there for a while.


Featured Stock Stories

post Posted: Aug 26 2014, 08:07 PM
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Traction appearing.This story has fascinated me for years.I have bought new stock again.

post Posted: Mar 21 2014, 04:06 AM
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Hi Guys.

Looks like a new CEO blog posting on the background to the latest Trx-1 news.

It's well worth a read.


post Posted: Dec 20 2013, 08:21 AM
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New Global Collaboration with Cornell University on Brain Cancer has just been announced.

Almost exactly a year to the day that Prof. Kelly took over the reins again and this good news is just the latest in a long line of such PR's over the last year.

Seasons Greetings to anyone still reading this board. <grin>

NOVOGEN LTD ­ ACN 063 259 754 16-20 Edgeworth David Ave, Hornsby, NSW, 2077 P: +61 (0) 2 9476 0344 - F: +61 (0) 2 9476 0388 NOVOGEN LIMITED
20 December 2013

Novogen Announces Establishment of Global Collaboration to Drive The
Development of Drugs to Treat Brain Cancer

20 December 2013, Sydney, Australia: Novogen Limited, an oncology drug development
company, announced today the signing of a Sponsored Research Agreement with Cornell
University. The Weill Cornell Medical College (WCMC) in New York will become the
cornerstone of a collaboration across Europe, US, Asia and Australia involving universities
and biotechnology companies seeking a treatment capable of delivering long-term remission
for the main form of primary brain cancer, glioblastoma multiforme (GBM).

The research program is focused on the super-benzopyran drug, Trilexium (Trx).

The brain cancer program parallels that of the Company's efforts in the area of ovarian cancer
through its joint venture, CanTx Inc, with Yale University.

CanTx has identified a Trilexium derivative (Trx-1) as having equipotent killing ability of both
ovarian cancer stem cells and ovarian cancer somatic cells, raising the prospect for the first
time of being able with the one agent to kill the full hierarchy of cells within an ovarian cancer.
The CanTx strategy is to bring Trx-1 into the clinic in the near-term as a generic treatment for
late-stage ovarian cancer, but then to use the Trx pharmacophore to create a panel of drugs
capable of killing ovarian cancer cells with specific genotypes, a further unique feature of this
technology platform.

The brain cancer program has the same R&D and commercial objectives. The near-term goal
is to bring Trilexium into the clinic as a generic treatment for GBM that has failed to respond
to Temozolomide, the only drug approved for GBM. The longer-term goal is to identify a panel
of drugs capable of providing a personalized approach to GBM chemotherapy.

The program is based on the high potency of Trilexium against GBM cells, with both GBM
stem cells and somatic cells being killed at equivalent dosages.
Progression of GBM following radiotherapy and chemotherapy is believed to result from the
regrowth of cancer stem cells that are chemo-resistant. Recurrent tumor cells, like their parent
GBM stem cells, are highly drug-resistant and with increased aggression, accounting for the
poor prognosis associated with GBM.

Dr David Brown, Novogen Group CSO, said, "The collaborative effort to date has focused on
bringing Trilexium into the clinic for the treatment of GBM, and that goal will continue with
the aim of bringing that agent into the clinic in early 2015."

"The expansion of the collaboration to include Cornell takes the program to the next level,
which is to achieve personalized chemotherapy for patients with GBM. The objective is to
identify a panel of Trx analogs that target individual GBM mutations within the genotype
spectrum that characterises GBM malignancies. That data then will inform our clinical
objective which is to match the best drug candidate to an individual tumor genotype."

"WCMC has particular skills in identifying the genotype of explants from fresh biopsies of
GBM tumors. We will be utilizing this ability to screen Trilexium analogs for activity against
a wide range of individual tumors," Dr Brown added.

About Glioblastoma
Glioblastoma multiforme is the most common and aggressive form of primary brain tumor.
Worldwide, in developed countries, an estimated 3.5 cases per 100,000 people are diagnosed
per year. Glioblastoma is one of the cancers most resistant to treatments and is associated with
extremely poor prognosis. Despite therapeutic intervention (surgery/radiation/chemotherapy),
glioblastoma remains a devastating disease with a median 2-year survival rate in the range of

About Novogen
Novogen Ltd is a public, Australian biotechnology company whose shares trade on both the
Australian Securities Exchange (`NRT') and NASDAQ (`NVGN'). The Company is based in
Sydney, Australia, and with a US office in New Haven, Connecticut. The Company has two
main drug technology platforms known as super-benzopyrans (SBP) and anti-tropomyosins
(ATM). SBP drugs target cancer stem cells and are being developed for the treatment of
ovarian cancer and glioblastoma. ATM drugs target the cancer cell cytoskeleton and are being
developed for the treatment of melanoma, prostate cancer and neuroblastoma. Novogen has
entered into a joint venture with Yale University known as CanTx Inc with the aim of
developing personalized chemotherapy for patients with ovarian cancer.

post Posted: Nov 24 2013, 07:36 AM
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Here's a link to a short news item on Australian TV about the recent announcement of the effect the new cancer compounds are having on the cells of muscular dystrophy.

Doc Kelly has a short piece to camera but it mainly features a young boy with the disease.

Good bit of early publicity for the company.... let's hope there is lots more to come both on the cancer treatments and degenerative diseases too.




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