CLARITY PHARMACEUTICALS LTD (ASX:CU6) - CU6 - Media and Industry News, page-148 - HotCopper | ASX Share Prices, Stock Market & Share Trading Forum

Originally posted by ttppxx: ↑

Let me try to answer (happy to be corrected)
"Why would J&J be presenting/Why was it accepted by ASCO?"

ASCO (or any legitimate conference or journal) acceptance is based on the quality of the work itself (importance to science being a major consideration). The results, whether positive, neutral, or negative, must not influence the decision to accept (if that happens, you create publication bias). JNJ will know too well not to engage in such.
JNJ’s (Jansen’s) Clinical Data Transparency statement says: “We seek to publish, in peer-reviewed journals, results from all company-sponsored pharmaceutical Phase 2 through 4 clinical trials and Phase 1 trials in patients. Studies that terminate early (prior to pre-specified study end date) are included in our commitment to publish, provided they yield scientifically or medically important results”.

"The patient who died had Covid which would likely be not treatment related?"
From the limited info so far, they have classed it as a Treatment Emergent Adverse Event (TEAE), as it occurred once treatment had started. Further; not all Covid positive patients die from Covid, plus in the study almost all patients developed some adverse effects from treatment: 61% classified as Grade 3 or higher (Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event).

"Despite the poor results their HREC is continuing the trials for patients who want to continue treatment despite knowing the interim results - should we interpret it as a serious lack of alternatives?"
The continuation – I do not know! But the report mentions they are evaluating “adaptive dosing”. I do not know what this means with regards to continuation – are they analyzing what they have, or have they recruited more? The aim was to recruit about 50, and they managed to get 64, which suggests they are done.
The timing between when the patients died and when HREC analysis would have allowed continuation is not in the reports so no idea what they decided post the 4 deaths.
Lack of alternatives: Probably not the case – Plutivo is available and per Report 2, it had better results in the Phase 3 trial.

ALSO WORTH NOTING (Asper Trial protocol)

Primary Outcomes
Number of Participants with Adverse Events (AEs)
Number of Participants with Dose-Limiting Toxicity
Number of Participants with AEs by Severity - Grade 1 (Mild) to Grade 5 (Death)

Secondary Outcomes
PSA response rate is defined as the percentage of participants with a decline of PSA of 50 percent (%) or more from baseline and that is subsequently confirmed.
Plus Others

BIG QUESTION: Will JNJ continue?
The adverse effects were common and quite serious. 61% severeand 6% deaths. But we know that the objective was to determine the recommended dose, andindeed, a ‘cumulative dose cap’ and an ‘adaptive dosing schedule’ have beenrecommended by the researchers. Whether that’s acceptable and justifiescontinuing or not – no idea!

In my view (from limited data): the comment that suggests inferior efficacy versus the standard (Pluvicto) isimportant. Yes, it’s a Phase 1 for JNJ-6420 and the Pluvicto trial referred to was a Phase 3: BUT, butto have inferior efficacy when you are dosing in a way that allows you to push to the maxtolerable (to a point where serious AEs are experienced), suggests to me that continuing would be a futileexercise!

The presentation or poster will have more information than what the reporters got from the abstracts so I think we will know more soon. Clarity will be at the conference too!

Expand

Apologies for the terrible formatting, the spacing, and the numbering (bulleting) - the system is something else. I hope you can all make sense of what I am trying to say.

No.	Vol.	Price($)
1	442	$6.22

No.

Vol.

Price($)

442

$6.22

Price($)	Vol.	No.
$6.27	5000	1

Price($)

Vol.

No.

$6.27

5000

No.	Vol.	Price($)
1	442	6.220
1	1200	6.210
4	13522	6.200
1	3907	6.190
3	23216	6.180

No.

Vol.

Price($)

442

6.220

1200

6.210

13522

6.200

3907

6.190

23216

6.180

Price($)	Vol.	No.
6.270	5000	1
6.290	3620	2
6.300	20816	2
6.310	1700	1
6.320	4895	2

Price($)

Vol.

No.

6.270

5000

6.290

3620

6.300

20816

6.310

1700

6.320

4895

(20min delay)
Last $6.22		Change 0.030(0.48%)		Mkt cap ! $1.959B

Open	High	Low	Value	Volume
$6.22	$6.35	$6.20	$5.199M	827.0K

CU6 - Media and Industry News, page-148

Emerald & Azure score Digger & Dealer awards

IRIS Metals sniffs 75 metres of lithium in South Dakota, pushing share price up 9.99%

Orpheus delays drilling at South Australian play Frome, on traditional owner advice

Bitcoin: Current State of Play & Where to Next | Swyftx

Livehire sees share rocket 91% on takeover bid by Humanforce

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

CU6 - Media and Industry News, page-148

Top Stories

Emerald & Azure score Digger & Dealer awards

IRIS Metals sniffs 75 metres of lithium in South Dakota, pushing share price up 9.99%

Orpheus delays drilling at South Australian play Frome, on traditional owner advice

Bitcoin: Current State of Play & Where to Next | Swyftx

Livehire sees share rocket 91% on takeover bid by Humanforce

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News