SPL
now this is just my opinion and based on a bit of research it maybe possible to join the company dots and
see what SPL is working on and for whom.
Lets look at one of these first.
Geron Corporation is currently conducting four human clinical trials involving telomerase inhibition and telomerase
vaccination. Basically when a cell divides a little bit of telemorase is left off each time and this is one of the reasons
why we age/get disease etc.
However, when a cancer cell divides it is 100% intact, it continues to divide and grows with its telmorase uninhibited.
So its a bit of a 2 way street that Geron is working on. Kill cancer cells by inhibiting telmorase and life extension uninhibiting telmorase in normal cells .
The first approach maybe is to switch off the telomerase to accellerate the cancer cells aging or to get the body to attack
these cancer cells by recognising that they are expressing and not inhibiting telemorase.
The second way is to inhibit telomerase degradation in healthy cells and in some ways re grow the telomerase for a healthier better life. THis is one of the reasons that Geron recently took out a patent on a plant derivative that regrows telomerase.
Its actually a chinese medicine thats been used for centuries.
Just by accident researchers injected genetically modified mice (with no fur and prone to cancers) with their vaccine and after a week decided it didnt work and put the mice back in storage. After checking on the mice 3 months later the mice had all grown massive fur and other tests proved that their telemorase had regenerated and some of the cancers deminished or gone.
Heres where it gets interesting
Merck, as a licensee of Geron, has recent approval of an IND for one vaccine type. The vaccine platform is
being tested (and now jointly with Merck) using three different approaches.
One vaccine is adenovirus/plasmid based (Merck IND).
The second is an autologous dendritic cell based vaccine (GRNVAC1), formerly called TVAX when tested in Phase I
clinical trials in Prostate Cancer, and it showed significant PSA doubling times as well as T-cell response.
Geron's embryonic stem cell derived dendritic cell vaccine targeting telomerase is the third approach and is currently at
the pre-clinical stage. These vaccine methods attempt to teach the human immune system to attack cancer cells expressing telomerase. Geron's telomerase inhibitor drug (GRN163L) attempts to stop cancer cell proliferation by inhibiting telomerase and it is in three separate early stage human clinical trials.
OK the second and third vaccine is using dendritic technology and Merke is a licensee of SPL, therefore one maybe able to
conclude that SPL is using its dendrimer subsidiary company to develop vaccine GRNVAC1 and GRN163L for them.
This is possibly the trail so far.
Of course all this has to go through the regulatory process known as FDA
Most drugs however to treat HIV or cancer may get approval under accelerated approval provisions, with the company required to continue its studies after the drug is on the market to confirm that its effects on virus levels are maintained and that it ultimately benefits the patient. Under accelerated approval rules, if studies don't confirm the initial results, the FDA can withdraw the approval.
Note that SPL is a very advanced company in Dendrimer technology and has some products on the market already.
THerefore
It maybe concluded that as there is nothing close to Vivagel on the market and as it has successfully gone through phase 1 and that phase 11a has gone according to schedule with no known side effects and that SPL'S Vivagel may get released sooner than later. After all FMCG company Reckitt Benckiser who bought out SSL / DUREX condom company has to start paying royalties now for the use of the Vivagel as an anti AIDS lubricant.
I note and correct me if you know otherwise that i have never seen Vivagel referred to as a drug and so can therefore presume that it is being FDA approved differently? Vivigel
The work for Merke and Geron is of course possibly one of the ND works they refer to and so should generate royalties and milestone payments as well.
last note - FDA states that if theres nothing else on the market then it is possible that after phase 1 and 2 and the good out weighs the bad then it has the power to allow the product to market.
Next post will be SPL's relationship with UNILEVER
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