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Clinical Trial Results:
EFFICACY AND SAFETY OF A SINGLE TRUS-GUIDED INTRAPROSTATIC INJECTION OF NX-1207 IN PATIENTS WITH LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA: A PHASE III EUROPEAN CLINICAL STUDY

Summary
EudraCT number	2012-002451-41
Trial protocol	DE PT ES GB IT PL RO
Global end of trial date	25 Jan 2016

Results information
Results version number	v1(current)
This version publication date	21 Jan 2017
First version publication date	21 Jan 2017
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

NX1207-IT-CL0414

ISRCTN number

-

US NCT number

NCT02003742

WHO universal trial number (UTN)

-

Sponsor organisation name

Recordati S.p.A

Sponsor organisation address

Via Civitali 1, Milan, Italy,

Public contact

Clin. Proj. Leader - Medical Dep., Recordati S.p.A., +39 (0)248787183, miotto.f@recordati.it

Scientific contact

Clin. Proj. Leader - Medical Dep., Recordati S.p.A., +(039) (0)248787183, miotto.f@recordati.it

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

25 Jan 2016

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

25 Jan 2016

Was the trial ended prematurely?

Yes

Main objective of the trial

The primary objective of the core of the study was to demonstrate that a single TRUS-guided intraprostatic injection of NX-1207 provided a long lasting therapeutic improvement of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) in patients not adequately controlled by medical therapy with α-blockers, as assessed by a change from baseline in the International Prostate Symptom Score (IPSS) total score.

Protection of trial subjects

The study was conducted in EU and in extra-EU countries in accordance with the ethical principles that have their origin in the Declaration of Helsinki and in compliance with the protocol, Good Clinical Practice (GCP) guidelines (CPMP/ICH/135/1995), with Directive 2001/20/EC (for Europe [EU]), and with all local laws and regulations concerning clinical trials. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

11 Nov 2013

Long term follow-up planned

Yes

Long term follow-up rationale

Safety, Efficacy

Long term follow-up duration

12 Months

Independent data monitoring committee (IDMC) involvement?

No

Number of subjects enrolled per country

Country: Number of subjects enrolled

Poland: 38

Country: Number of subjects enrolled

Portugal: 13

Country: Number of subjects enrolled

Romania: 16

Country: Number of subjects enrolled

Spain: 13

Country: Number of subjects enrolled

Germany: 68

Country: Number of subjects enrolled

Italy: 25

Country: Number of subjects enrolled

Russian Federation: 33

Country: Number of subjects enrolled

United Kingdom: 6

Worldwide total number of subjects

212

EEA total number of subjects

179

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

162

From 65 to 84 years

50

85 years and over

0

Subject disposition

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Recruitment details

Investigators at 47 centres (4 in France, 12 in Germany, 5 in Italy, 5 in Poland, 3 in Portugal, 5 in Romania, 5 in Russia, 5 in Spain, and 3 in the United Kingdom) agreed to participate in this study. Study initiation date (Fist patient in): 11 November 2013 Study completion date (Last patient last visit): 29 January 2015

Screening details

Men aged 45 years or older with LUTS/BPH not adequately controlled by medical therapy with α-blockers and presence of moderate/severe LUTS (IPSS ≥ 15) at screening and at baseline (after a 4 week with tamsulosin 0.4 mg QD), Prostate Volume ≥ 30 mL and ≤ 70 mL (as assessed by TRUS) and Qmax < 15 mL/sec based on a minimum void of 125 mL.

Number of subjects started

212

Number of subjects completed

196

Reason: Number of subjects

Screening failure: 16

Period 1 title

Open-label Run-in period

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Run-in period

Arm description

A 4 week run-in period in which all subjects were treated with the most commonly used α-blocker at the current recommended dosage (i.e. tamsulosin 0.4 mg QD).

Arm type

Tamsulosin 0.4 mg

Investigational medicinal product name

Tamsulosin 0.4 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

All enrolled subjects received 1 film coated, prolonged release tablets of tamsulosin 0.4 mg to be taken per oral route once daily

Number of subjects in period 1 ^[1]	Run-in period
Started	196
Completed	104
Not completed	92
Consent withdrawn by subject	4
Run-in failure	21
Protocol deviation	67

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: A total of 212 patients have been screened and 196 enrolled in the run-in period. 16 patients were excluded prior to run-in period due to selection criteria not met (screening failure).

Period 2 title

Single-blind Randomised treatment period

Is this the baseline period?

No

Allocation method

Randomised - controlled

Blinding used

Single blind

Roles blinded

Subject

Are arms mutually exclusive

Yes

NX-1207 injection

Arm description

A single TRUS-guided intraprostatic injection of 2.5 mg of NX-1207 (NX-1207 arm) followed by 1 tablet of tamsulosin placebo to be taken orally QD

Arm type

Experimental

Investigational medicinal product name

NX-1207

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for solution for injection/infusion

Routes of administration

Intraprostatic use

Dosage and administration details

A single TRUS-guided intraprostatic injection of 2.5 mg of NX-1207 (NX-1207 arm) followed by 1 tablet of tamsulosin placebo to be taken orally QD

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

1 tablet of tamsulosin placebo to be taken orally QD

Tamsulosin 0.4 mg

Arm description

TRUS procedure only (comparator arm) followed by 1 film coated, prolonged release tablet of tamsulosin 0.4 mg, to be taken orally QD.

Arm type

Active comparator

Investigational medicinal product name

Tamsulosin hydrochloride 0.4 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Marketed tablets of tamsulosin hydrochloride 0.4 mg (film coated, prolonged release tablet - Omexel® L.P.).

Number of subjects in period 2	NX-1207 injection	Tamsulosin 0.4 mg
Started	49	55
Completed	4	4
Not completed	45	51
Consent withdrawn by subject	2	3
Adverse event, non-fatal	3	-
Drop out due to the early termination of study	38	-
Drop out due to the early termination of study	-	45
Lack of efficacy	2	3

Baseline characteristics

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Reporting group title

Open-label Run-in period

Reporting group description

-

Reporting group values	Open-label Run-in period	Total
Number of subjects	196	196
Age categorical
Men aged 45 years or older
Units: Subjects
Adults (18-64 years)	162	162
From 65-84 years	34	34
85 years and over	0	0
Age continuous
Units: years
median (full range (min-max))	66.5 (51 to 85)	-
Gender categorical
Units: Subjects
Female	0	0
Male	196	196
Ethnic group
Units: Subjects
Caucasian male	196	196

End points

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Reporting group title

Run-in period

Reporting group description

A 4 week run-in period in which all subjects were treated with the most commonly used α-blocker at the current recommended dosage (i.e. tamsulosin 0.4 mg QD).

Reporting group title

NX-1207 injection

Reporting group description

A single TRUS-guided intraprostatic injection of 2.5 mg of NX-1207 (NX-1207 arm) followed by 1 tablet of tamsulosin placebo to be taken orally QD

Reporting group title

Tamsulosin 0.4 mg

Reporting group description

TRUS procedure only (comparator arm) followed by 1 film coated, prolonged release tablet of tamsulosin 0.4 mg, to be taken orally QD.

Primary: Change from baseline in IPSS total score

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End point title

Change from baseline in IPSS total score

End point description

The primary objective of the study was to demonstrate that a single transrectal ultrasound (TRUS)-guided intraprostatic injection of NX-1207 provided a long lasting therapeutic improvement of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) in patients not adequately controlled by medical therapy with α-blockers, as assessed by a change from baseline in the International Prostate Symptom Score (IPSS) total score.

End point type

Primary

End point timeframe

Change from baseline in the International Prostate Symptom Score (IPSS) total score.

End point values	NX-1207 injection	Tamsulosin 0.4 mg
Number of subjects analysed	48	54
Units: IPSS total score
number (not applicable)	48	54

Descriptive statistics of the variables collected

Statistical analysis description

The statistical plan has been revised after the premature study termination.

Comparison groups

NX-1207 injection v Tamsulosin 0.4 mg

Number of subjects included in analysis

102

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

P-value

< 0.001

Method

ANCOVA

Parameter type

Mean difference (final values)

Confidence interval

level

95%

sides

2-sided

lower limit

-

upper limit

-

Variability estimate

Standard deviation

Notes
[1] - Due to the reduced number of patients randomised and completing the study only descriptive statistics on the parameters, as well as on the change from the baseline, were calculated. No treatment group comparison and any inferential statistical analysis as planned by the protocol has been performed. The efficacy and safety analisyses were based only the Safety Set. The Safety Set was defined as all patients who took at least one dose-post baseline of study medication.

Adverse events

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Timeframe for reporting adverse events

The period of observation for collection of AEs was extended from Visit 1 up to the final/early termination visit. In addition, all SAEs which came to the attention of the investigator within 4 weeks from the end of the study were also to be recorded.

Adverse event reporting additional description

Specific attention was requested for AEs involving the urinary tract and reproductive system, with special mention to infections, e.g: fever, urinary tract infections, prostatic infections, prostatitis, epididymitis, urethral infections, cystitis, even though these would not qualify as serious.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

16

Reporting group title

Run-in period

Reporting group description

-

Reporting group title

NX-1207 group

Reporting group description

-

Reporting group title

Tamsulosin group

Reporting group description

-

Serious adverse events	Run-in period	NX-1207 group	Tamsulosin group
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 196 (0.51%)	2 / 48 (4.17%)	0 / 54 (0.00%)
number of deaths (all causes)	0	1	0
number of deaths resulting from adverse events	0	0	0
Injury, poisoning and procedural complications
Thermal burn
Additional description: The death of patient was caused by thermal burn due to gas explosion. This patient had also experienced pneumonia, pyelonephritis and chronic obstructive pulmonary disease. All SAEs were considered as not related.
subjects affected / exposed	0 / 196 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Cardiac disorders
Sick sinus syndrome
Additional description: The investigator assessed the event as moderate and not related to study drug but to pre-existing condition.
subjects affected / exposed	1 / 196 (0.51%)	0 / 48 (0.00%)	0 / 54 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
Additional description: The investigator assessed the events as severe and not related to study drug as it was a known pre-existing condition.
subjects affected / exposed	1 / 196 (0.51%)	1 / 48 (2.08%)	0 / 54 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Pneumonia
Additional description: The investigator assessed the event as not related to study drug .
subjects affected / exposed	0 / 196 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pyelonephritis
Additional description: The investigator assessed the event as moderate and not related to study drug .
subjects affected / exposed	0 / 196 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Run-in period	NX-1207 group	Tamsulosin group
Total subjects affected by non serious adverse events
subjects affected / exposed	3 / 196 (1.53%)	6 / 48 (12.50%)	7 / 54 (12.96%)
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	0 / 196 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)
occurrences all number	0	1	0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	0 / 196 (0.00%)	3 / 48 (6.25%)	0 / 54 (0.00%)
occurrences all number	0	3	0
Nausea
subjects affected / exposed	0 / 196 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)
occurrences all number	0	1	0
Renal and urinary disorders
Dysuria
subjects affected / exposed	0 / 196 (0.00%)	2 / 48 (4.17%)	0 / 54 (0.00%)
occurrences all number	0	2	0
Infections and infestations
Bacteriuria
subjects affected / exposed	0 / 196 (0.00%)	1 / 48 (2.08%)	2 / 54 (3.70%)
occurrences all number	0	1	2
Cystitis
subjects affected / exposed	0 / 196 (0.00%)	1 / 48 (2.08%)	0 / 54 (0.00%)
occurrences all number	0	1	0

More information

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Were there any global substantial amendments to the protocol? Yes

28 Jun 2013

The aim of the Amendment No. 1 was to modify (on a conservative approach) the storage conditions of the investigational medicinal product under test and the handling and dispensing instruction, in order to better clarify the use of the reconstituted product. This amendment had no significant impact on the scientific value of the clinical trial. All subjects were enrolled in the study only after approval of Amendment No. 1.

25 Jul 2014

The aim of the Amendment No. 2 was to modify exclusion criteria No. 12: “Poorly controlled diabetes (type 1 or type 2), as determined by HbA1c >6% and/or glycosuria” in “Poorly controlled diabetes (type 1 or type 2), as determined by HbA1c > 7% and/or glycosuria”. In order to avoid excluding from study participation patients who have an acceptable glycemic control as per reference scientific guideline and medical practice. This amendment had no significant impact on the safety of the patients or the scientific value of the clinical trial.

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
26 Nov 2014	After the news released by the Nymox Pharmaceutical Corporation (originator of NX-1207), announcing that their two double-blind, placebo-controlled, Phase III clinical trials conducted in the US with NX-1207 2.5 mg had failed to meet their primary efficacy endpoint, the clinical trial was prematurely terminated. Since only a minority of patients had completed the 12 month study period, the investigators were asked to proceed to schedule an early termination visit at a suitable date for the patient.	-

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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