Proposed Directors of Tirupati Graphite explain why they have requisitioned an GM. Watch the video here.
The 3 weekly trials matched the present dosing regimes for doxorubicin. They might have had to have copied this in their original trials. Also the data they’ve collected and analysed might, I accept might, be suggestive of a benefit with fortnightly dosing. I’m sure they haven’t decided on a fortnightly trial without very good reason.
Morning Ice, the small trial of fortnightly dosing makes some sense to me. Marking sure they get the Phase 2 trial design absolutely correct is worth a small delay. The potential to optimise safety and efficacy now will pay off in the long term. But agree it does frustrate the timeline.
Morning Bella, totally agree. We must remember this is a selected, FAP level proven, group of patients. Not the more generalised end stage cancer patients the present trials have been performed in. Please excuse the bluntness, not meant to demean the sufferers are helping us by taking part in the trials.
Agree with comments about so much being known about plain and simple doxorubicin. This, together with Orphan Drug Status, has got to make the path to a product license a relatively quicker process. Still safe, the trials will need to be done, but hopefully more straightforward.
It’s worth looking at the support the FDA and EMA give to Orphan Drug development. It’s reassuring.
Novartis have a drug development portfolio interest in FAP / FAPI for diagnosis and treatment. A cheeky google search shows the potential for FAP related Pharma.
https://www.novartis.com/news/media-releases/novartis-expands-targeted-radioligand-therapy-pipeline-license-compounds-targeting-fibroblast-activation-protein-fap
This 2020 overview of FAP in health and cancer is interesting:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7487063/
Good post B2HS2L. Links nicely with this:
https://pubmed.ncbi.nlm.nih.gov/37333052/
Looking at FAP levels in sarcomas in 2023.
Worth a read. People have had enough of side effects. Patients and doctors are requesting minimum effective dose, not maximum tolerated dose. If only there was a delivery platform that enabled this. Oh…
https://dailyprogress.com/news/nation-world/business/health-care/cancer-treatment-drugs-fda-doses-lung-breast/article_4b5b24b8-21b2-5630-953e-ad837ea32f9c.html
Poor 💩🦷W⚓️. No one listened. The short position has been closed.
Those that can do, those that can’t become hedge fund managers (failed), pizza restaurant owners (failed), journalist (failed), share tipsters (fai… you get the idea.
May I add / change my post? Normal doxorubicin can be given into a fast flowing drip = large vein. But it can cause significant tissue damage if the drug leaves the vein (extravasates). This can lead to plastic surgery intervention. AVA 6000 shouldn’t show this degree of toxicity. Sorry for any potential to mislead with the post re central lines.
https://www.termedia.pl/Case-report-Extravasation-of-doxorubicin-a-dreaded-complication-of-therapy,77,22239,1,1.html
SORRY: I retract it.
“ Administer diluted Doxorubicin Hydrochloride Injection or diluted reconstituted Doxorubicin Hydrochloride for Injection as an intravenous injection through a central intravenous line or a secure and free-flowing peripheral venous line containing 0.9% Sodium Chloride Injection, USP, 0.45% Sodium Chloride Injection, USP, ...”
From Pfizer.
“ Doxorubicin is given: by injection into a vein (intravenously) through a fine tube (cannula) placed into the vein in your arm. through a central line (Hickman / Portacath), which is inserted under the skin into a vein near the collarbone, or into a PICC line which is inserted into a vein in the crook of your arm.”
Ref to follow.
B2HS2L. Excellent post. Worth adding that AVA6000 is given by a simple drip in the back of the hand. Normal doxorubicin HAS to be given by a central line. This was confirmed following a personal message to one of Avacta’s team on LinkedIn. Sorry I can’t prove this. This adds to the paradigm shift. It’s easier, cheaper, and most importantly safer for the patient and healthcare team.
Ice, couldn’t agree more. With the massive amount of proven data about ‘normal doxorubicin’, we’ll be able to establish trends away from this very quickly in the ongoing and upcoming trials. It’s going to be interesting to see how Avacta have proven the tumour FAP levels prior to treatment, and then the response seen in the tumour. This is going to take more time. But time very well spent. We’re closer to FAP testing being part of the standard of care in oncology.
Morning Ice, I’m going argue this point.. “ The efficacy of Dox was never the issue, we know it kills cancer, it was always about the safety and tolerability at very high levels.”
Doxorubicin has cancer killing properties, obviously, but isn’t brilliant. The Multi Drug Resistance seen affects so many patients. I think and hope part of the paradigm shift we’ll see is enhanced cancer killing because of the supra normal cellular levels we’ll see in FAP rich tumours. So my argument is this is as much to do with enhanced efficacy as it is with safety. Win win.
This site is showing 278,899 Avacta shares held short. Time to start buying at this bargain sp. For us and to short squeeze the William Ankers.
https://fintel.io/ss/us/avctf
Here’s an old (1999) but I think very relevant piece of research. It shows the gradient of Doxorubicin concentration occurring in breast cancer cells, from the periphery to the centre of the tumour.
We know Multi Drug Resistance is a therapeutic issue for Doxorubicin, this might help explain why. The sub therapeutic dose allows the selection and proliferation of drug resistant cells.
AVA6000 may well allow such an overwhelming delivery of doxorubicin, even if a gradient exists those cells in the centre receive a significant / effective dose of chemotherapy.
Worth thinking about?
https://aacrjournals.org/clincancerres/article/5/7/1703/287594/Doxorubicin-Gradients-in-Human-Breast-Cancer