Valirx Share Discussion Threads

[the stigologist] 28/9/2020 07:22

Triple Whammy good news for PYC from VAL news

1. ORR of 50% is very good early result. Shows promise to get VAL201 licensed to a bigger player. Physiomics get FREE CARRIED UPSIDE and share of ANY licensing income (including upfronts, milestones, royalties)

2. Note VAL comment on 'optimal dosing strategies'. Given PYC helped them develop drug in first place Physiomics should get follow on work now to develop these 'optimal dosing strategies' given Physiomics are experts in Modelling and Simulation of exactly that

3. In considering Partnering Physiomics modelling expertise can also be used to model which drug will work best in combination with VAL201 and this can be used to narrow search for best partner.

[the stigologist] 28/9/2020 07:22

Triple Whammy good news for PYC from VAL news

1. ORR of 50% is very good early result. Shows promise to get VAL201 licensed to a bigger player. Physiomics get FREE CARRIED UPSIDE and share of ANY licensing income (including upfronts, milestones, royalties)

2. Note VAL comment on 'optimal dosing strategies'. Given PYC helped them develop drug in first place Physiomics should get follow on work now to develop these 'optimal dosing strategies' given Physiomics are experts in Modelling and Simulation of exactly that

3. In considering Partnering Physiomics modelling expertise can also be used to model which drug will work best in combination with VAL201 and this can be used to narrow search for best partner.

[thebossman] 28/9/2020 07:20

RNS Number : 2179A

ValiRx PLC

28 September 2020

28 September 2020

("ValiRx", the "Company" or the "Group")

VAL201 Clinical Trial Update

Headline results demonstrate VAL201 has potential to be a safe and well-tolerated drug

London, UK ValiRx (AIM:VAL) reports today that it has received headline results from the recently completed Phase 1/2 clinical trial of its lead asset VAL201, for the treatment of advanced prostate cancer, held at University College Hospital (UCLH), London.

The headline results, detailed below, provide a summary of the top-level data of safety and tolerability as well as evidence for disease impact as observed during the clinical trial. Full data and details of from the clinical trial are expected to be received by the Company by end Q4 2020.

Disease Impact - Overall Response Rate 54.5%

Evidence for positive disease impact has been measured using PCWG2 (Prostate Cancer Working Group 2) guidelines. These industry standard guidelines take into account both the primary tumour and metastatic tumours alongside prostate specific antigen (PSA) levels to assess whether the disease has progressed, or whether the patient has responded and halted disease progression. These guidelines provide a more comprehensive measure of disease impact than just primary tumour imaging.

Of the 12 patients dosed with VAL201, 11 patients had sufficient PCWG2-relevant data collected across multiple cycles. 6 of these 11 have been categorised as responding throughout treatment. That is, when the treatment with VAL201 was halted for a defined reason, whether or not the 6 standard cycles had been completed, these patients showed no disease progression by PCWG2 criteria with stable disease.

Safety and Tolerability - no Maximum Tolerated Dose declared

As the first clinical trial of VAL201, safety and tolerability data are of paramount importance.

The headline safety and tolerability results demonstrated only one dose-limiting toxicity event occurred. This was at a maximum dose of 8 mg/kg, with the patient having raised blood pressure (severe hypertension). Following treatment for the raised blood pressure, the patient completed the remainder of the trial.

A Maximum Tolerated Dose has not been determined for VAL201, and all doses remain available for further testing.

No deaths were reported in patients during the clinical trial.

Further minor events listed as likely to be related to the administration of VAL201 are: Injection site disorders in 11 out of 12 patients; fatigue (5/12); dyspepsia (1/12); muscle spasm (1/12); hypertension (2/12); bradycardia (1/12).

Next Steps

During Q4 2020, the Company expects to receive the full Clinical Study Report and will use the complete data to publish the results on the National Institute of Health's (NIH) public database ClinicalTrials.gov, as well as to produce research papers for peer-reviewed publications.

The Company intends to share these results with potential industry partners to evaluate all options for further clinical development of VAL201.

Dr Suzy Dilly, Chief Executive Officer commented: "I am delighted to be able to share these exciting results today, which are an accumulation of a lot of work by the wider team, both within and external to ValiRx. While considering these results it is important to remember that this is only the first clinical trial using VAL201, so this data has been generated using the utmost caution in sequentially dosing patients. Nevertheless, the headline results clearly demonstrate that VAL201 has the potential to be a safe and well-tolerated drug. With this data in hand, future studies will investigate optimal dosing strategies for VAL201 and help confirm these early indications of a positive response rate."

Professor Alan Boyd, Consultant Pharmaceutical Physician and Medical Monitor for the study commented: "Development of effective treatments with low-side effects for patients with prostate cancer who have relapsed after radiotherapy is essential and will improve the lives of patients during treatment. I am pleased to have contributed to a project that has demonstrated such a good safety and tolerability profile while giving the first indications of a favourable effect on the patient's disease."

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

For further information please contact:

[bloomberg2] 28/9/2020 07:19

https://youtu.be/8g_GeQR8fJo

[shares188] 28/9/2020 07:17

Very impressed
This will explode today

[stumbleupon] 28/9/2020 07:13

Lets hope so....

[montynj] 28/9/2020 07:12

Good for PYC

[nobbygnome] 28/9/2020 07:11

Well the results are better than I expected as a response rate of 54% is good in these sorts of patients. EVG's breast cancer drug got a response rate of around 25% in severe patients and that was seen as a big success.

[wulber] 28/9/2020 07:07

The Company intends to share these results with potential industry partners to evaluate all options for further clinical development of VAL201.

[412069] 28/9/2020 07:06

They’ve done it over a £1 today.

[reidy66] 28/9/2020 07:04

Wakey wakey people RNS out !!

[shares188] 27/9/2020 21:01

SNG, mark Two!

[nico115] 27/9/2020 20:46

If 201 is good then 100p -60m mkt cap is easily achievable

[carlisle44] 27/9/2020 20:41

TBurns post 1052 what is the planned extension that you mention?

TIA

[nobbygnome] 27/9/2020 20:06

£40-50 million looks fair to me with a half decent trial result. The drug still has a long way to go to get to the market....but I would settle for £100 million for sure!

[jusjusjus] 27/9/2020 18:15

LSE board getting over-excited, predictions ranging from £100m to £500m mkt cap!

[jack1236] 27/9/2020 17:42

O/T tburns you have a pm.

[jusjusjus] 27/9/2020 17:28

Latest update from July

Waiting with great anticipation for version no. 14 (results)

[tburns] 27/9/2020 14:12

Any chance you could share here 412? TIA

[412069] 27/9/2020 14:02

Read Graces post over on lse very very informative indeed.

[ball deap] 27/9/2020 13:10

Keep the faith guys, I've heard rumours Paul Hollywood has taken a holding !!!

[tburns] 27/9/2020 10:26

Morning Nobby, yes v. exciting week ahead, on the basis that both VAL and DNL come good then our planned extension will be covered by pharma profits from the past 3 months.

I still don't fully understand the delay with SNG, although this has allowed me to buy backin 80p below the high price post the July RNS. Have a good one too. GLA

[nobbygnome] 26/9/2020 17:28

>> tburns

It should be an exciting week next week for VAL and DNL and hopefully also SNG. It's what investing in these small biotechs is all about. It is rarely smooth but the roller coaster ride usually gives lots of thrills and spills!