Updated 21st March 2021
Thankful to a fellow patient for this update from Professor Essand.
“The AdVince trial is actively recruiting NET patients with liver metastases. The AdVince trial is a so-called phase I dose escalation study with four dose levels and we are currently treating at dose level three (so far without observing severe toxicity). As for all phase I studies, the primary endpoint is safety and to determine maximum tolerable dose of the oncolytic AdVince virus. We are of course also looking for efficacy. We have for practical reasons so far only included local patients for the dose-escalation part (phase I). This is because of the complex treatment schedule with virus infusion on days 1, 8, 22 and 50 and follow up examinations on day 80. Patients are hospitalised three-four nights during each treatment because we are required from the authorities to collect blood, urine and saliva samples to follow virus replication. The clinical phase II (efficacy) trial will open after completion of the phase I part (hopefully 2022) and we hope to make the clinical protocol somewhat easier then, not having to hospitalise patients that long”.
Updated 30th September 2020
Seneca Valley Virus (SVV-001) announces the reactivation of their phase I/II trial after it was halted last year. Read more below.
Updated 6th July 2020
AdVince has so far been tested in six patients in Sweden by Prof Essand, who is one of the two largest shareholders in Elicera. The company has now opened a second clinical site in Tubingen in Germany and is gearing up for a trial of 12 patients. Here’s a quote from the Professor:
“Since it is the first time this medication is being tested in humans, the Medical Product Agency (Swedish FDA) and ethics committee require that we start with dose escalation (phase I) to show that the treatment is safe. We have four dose levels with three patients per dose level and each patient is treated four times over two months and then evaluated one month later. We have treated six patients so far and thereby finished the two lowest dose level so far without observing any severe toxicity and encouraging responses. However, the trial is ongoing and it is still too early to draw any firm conclusions”.
What exactly are Oncolytic Viruses?
Oncolytic Viruses infects and breaks down cancer cells but not normal cells. Oncolytic viruses can occur naturally or can be made in the laboratory by changing other viruses. Certain oncolytic viruses are being studied in the treatment of cancer. Some scientists say they are another type of immunotherapy whilst others say it’s too early to classify as such. The good news is that Neuroendocrine Cancer seems to figure in this work with two of these viruses apparently working on mice to date. Listed below are two active projects involving NETs, one directly and one indirectly.
The Uppsala Trial – AdVince
Read here for an update released 7th June 2019.
I’ll briefly describe what’s happening and then you can link to my Facebook article if you need more background.
The trial is called AdVince after Vince Hamilton who funded it. Unfortunately he died before he saw any output but his forward thinking and benevolence lives on and might hopefully help NET patients in the longer term. It’s quite a small trial and is being conducted in Uppsala University Sweden, a famous European NET Centre of Excellence and where many people from across the world attend to take advantage of PRRT availability and experience and is home to famous NET specialist Kjell Öberg, MD, PhD, a professor of endocrine oncology.
A Swedish man (Jan-Erik Jannsson) was the first to get the virus to their cancer (NETs) using a genetically modified virus.
Unfortunately, I was given the news from a source close to the trial that Jan died last year of pneumonia. I have no evidence to suggest his death is in anyway connected to the trial but I’m told he was an ill man prior to the trial commencing. I have therefore dedicated this post to him. RIP Jan.
The initial data presented by the trial indicated that AdVince can be safely evaluated in a phase I/IIa clinical trial for patients with liver-dominant NET. The last I heard from the trial is that they are trying to recruit a further 12 patients to Phase IIa (the trial document allows for up to 36).
Read more background on my Facebook post here: Click here
The trial document on Clinical Trials Website: Click here
Then read this status update from the trial sponsors released in March 2018
Seneca Valley Virus (SVV-001)
This virus trial was active last year but was halted. It now appears to be reactivated according to Seneca Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to the development of oncolytic immunotherapeutics for cancer based on Seneca Valley Virus (SVV-001). Seneca announced the receipt of positive guidance from the FDA on the reactivation of the SVV-001 IND and Phase I/II protocol. The Phase I/II study will be in combination with a checkpoint inhibitor and include patients with either neuroendocrine tumors (NET) or carcinomas (NEC). The Phase I/II clinical study should begin during 2nd quarter, 2021. Read more here.
Clearly, it’s still early days in the Oncolytic Virus field with minimum breakthroughs in terms of success on humans. In terms of the Neuroendocrine connection. We are waiting to hear from Uppsala about how the human test of AdVince is coming along. My agents are scanning the internet every day looking for any comment.
If you want to learn more about Oncolytic Viruses in general – there’s a great summary here.
Clinical Trials Disclaimer
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact.
Inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan.
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