Cel Sci Corporation (CVM)

[GD]

His/her prediction "study might just show a small positive benefit." explains well why Geert wants to PR the complete data at the first PR
to fight the short attack of how useful in real setting and limited sales potential that sure will come after the data PR, IMO.

Soxrates:

in real life I’m a doctor that treats people with cancer. So thank you for that movie critic comment. It’s nice to see how you’ll treat your future potential customers.

I have no financial stake regardless of the outcome of your drug or company.

I wish you and the drug well. I hope for the sake of patients it is an absolutely wonderful drug that provides a cure. My point of questioning was to understand your trial. Not attack your company. But also have some counter points or other interpretations that (while we don’t know the data) might be equally valid. Hype in cancer medicine is a real problem and does harm. If your drug really really works. Feel free to hype to the hilt. I’m the first to wax lyrical about BCR-ABL inhibitors for CML. But the reality is most cancer drugs benefit these days are much much more modest. Yes there is improvement but the industry and acts and prices these drugs like they are hugely transformative when looking at things that truly matter to patients like living longer and better the absolute benefits are often, unfortunately, small.

regarding the comment on “doing what has never been done before” and “will improve you chance of being cured”.

What exactly do you mean that’s entirely novel. I’ll agree your exact mix of cytokines to perk up the immune system might not have been tried. But we have tried drugs and cytokines in cancer to turn on the immune system including interferons, checkpoint inhibitors, CAR-T, cancer vaccines.

If successful will improve chances of being cured. The main word there is if. You don’t know the data yet. Like I said I hope you do get a positive result.

Also improved cure rates in adjuvant setting have been achieved before is why addition of radiotherapy and those concurrent chemoradiotherapy regimes are standard of care.

I’ll admit I haven’t read all of your preclinical science. But what I have read is huge numbers of clinical trials in oncology. And it’s littered with trails that are negative that had solid pre clinical science behind them. This space is hard, and to come at people with valid concerns on clinical aspects of your trial and fob them off as just a short seller or uninformed is not helpful.

5) “ are you telling me that you prefer the activation of an immune system that has already been destroyed to one that is still fine”.

A. Obviously not. But that wasn’t my question and you know that. Nice bait and switch.

B. My question was why didn’t you trial this in a metastatic or relapse setting first before moving forward to neoadjuvant setting. All successful (neo)adjuvant therapies have activity in the metastatic setting. You could have run a relapsed metastatic trial the event rate would have been quicker to accrue as these patients are sicker. And if successful you have gone to market sooner and helped more patients sooner. You could then run your neoadjuvant trial safe in knowledge you have some market share, more information on likely toxicity and a better handle of likely effect size.

You might say yours is different due to novel mechanism of action and the immune system is “destroyed” by this point.

You must know that we have the option of nivolumab post chemotherapy, which despite being in a setting of a “destroyed immune system” still showed a survival benefit. Both that and your therapy will rely on some functioning immune system. The fact that you seem reluctant to test in this setting is red flag to me. For immunotherapy in head and neck Nivolumab is the bar and it has data in that setting. Why can’t you. Is it cause you expect it to not work, if so why? Is it that multikine isn’t as immunologically stimulating as nivolumab.

Comparing your results to the adjuvant nivolumab setting is going to pretty interesting. I’ll watch closely for the NIVOPOSTOP and IMSTAR-HN trials.

6) regarding your comment on the SEER data being from same tumour stage, obviosuly. that wasnt my issue. in the SEER data your going to get a group of people all say T3N0M0. but within that group is going to be some fit well people with T3N0M0 and some who have got comorbidities and maybe other problems. If you look at the median survival kf the SEER data its going to be derived from a mix of the fit and not fit ones.

now you have your trial. whose clinicaltrials.gov entry i found. And its not surprising your trial has to go on longer than the median OS for SEER. because you selected for people with good performance status, no immunosuppression and even explicitly selected for a life expectance longer than 6 months. Also depending on how you define functioning immune system and immunosupression in your trial protocol may exclude a large market share of patients with COPD who need steroid inhalers. if you excluded them you have a much fitter trial population than your average person in SEER with the same stage.

These are all valid points about your trial and trial design in general and will be key to interpreting the value of mutlkine or lack of depending on what the data show.

My prediction would be this. Your study might just show a small positive benefit. I persoanlly expect part of the reason it’s gone on so long is to see the LI relevance compared to your cyclophosphamide mix. You’ll get FDA approval because the bar is so low these days. You’ll get snapped up by some big pharma mostly to acquire the IP and bring development in house to avoid you getting lucky and stumbling on something useful and profitable so they dont miss out and avoid another AMGEN.

Depending on how you price things and the relevence of the cyclophopshamide you may struggle to go for the european market and you won’t like having the meet the QALY thresholds.

You’ll get a few years of market share in the US but alot of people will just use the zinc and cyclophosphamide mix. Then the nivolumab trials will publish. They’ll beat you, I’m sorry that just looks likey at this point. Your market share will shrink. but you wont care. you’ll have made lots of money by then.

https://www.reddit.com/r/IAmA/comments/i8hv6n/i_am_geert_r_kersten_i_have_been_working_in/?sort=new