Proellex-V (telapristone suppository)
/ AbbVie
- LARVOL DELTA
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February 10, 2012
Evaluation of safety, pharmacokinetics, and efficacy of Proellex administered vaginally in women with uterine fibroids
(clinicaltrials.gov)
- P2, N=36; Not yet recruiting → Recruiting
Enrollment open • Uterine Leiomyoma
May 16, 2013
Evaluation of safety, pharmacokinetics, and efficacy of Proellex administered vaginally in women with uterine fibroids
(clinicaltrials.gov)
- P2, N=36; Sponsor: Repros; Active, not recruiting -> Completed.
Trial completion • Uterine Leiomyoma
June 07, 2012
Jefferies Global Healthcare Conference
(Repros)
- Anticipated P2 study data for uterine fibroids in Q4 2012
Anticipated P2 data • Vaginal Atrophy
April 18, 2014
Extension of study ZPV-200
(clinicaltrials.gov)
- P2, N=48; Sponsor: Repros Therapeutics; Enrolling by invitation -> Completed; Primary Completion Date: Sep 2013 -> Apr 2014.
Trial completion • Uterine Leiomyoma
January 03, 2013
Repros' Proellex-V topline analysis suggests 12 mg dose effective and well tolerated in phase 2 for uterine fibroids
(Repros)
- P2, N=40; ZPV-200 (NCT01451424); "Company to request end of Phase 2 meeting with FDA during Q1 2013...The reduction in fibroid volume was significant for the 12 mg dose as compared to either the 3 or 6 mg dose group (p=0.002 and p=0.01, respectively)...58% of the women on the 12 mg dose ceased menstruation whereas 18% of the combined 3 and 6 mg doses stopped...The Company has put in place an extension study to begin to build the 1 year exposure safety data base that will be required for an eventual NDA submission."
Anticipated FDA event • P2 data • Uterine Leiomyoma
January 03, 2015
Now may be the time to buy Repros Therapeutics
(SeekingAlpha)
- "Additionally, the company was also allowed by the FDA to carry out two Phase II/b studies for uterine fibroids, using both oral and vaginal administration of Proellex. These trials have an estimated primary completion date of December 2015, if enrollment goes as planned, and based on positive results, Repros will schedule a Type-C meeting with the FDA around the end of this year. The meeting will decide on the important question of the size of the safety database. If the Phase III trial requires yearlong data for safety and everything goes smoothly, then by the end of 2017 the company should be preparing for an NDA submission of Proellex."
Anticipated FDA event • Anticipated NDA • Anticipated trial primary completion date • Endometriosis • Uterine Leiomyoma
September 08, 2011
Repros Therapeutics Inc- Corporate Update
(Repros)
- Repros has submitted IND application with FDA for vaginal administration in the treatment of uterine fibroids
IND submission
November 05, 2012
Repros to present Androxal and Proellex clinical updates at the Lazard Capital Markets 9th Annual Healthcare Conference
(Repros)
- Repros will present clinical updates for Proellex programs on Wednesday, November 14, 2012, at 8 am Eastern time
Anticipated clinical guideline • Endometriosis • Uterine Leiomyoma
December 29, 2014
Repros initiates two phase 2b uterine fibroid studies
(Repros Press Release)
- "Repros Therapeutics...today announced it has initiated two Phase 2B efficacy studies of Proellex® in the treatment of uterine fibroids in women that experience heavy vaginal bleeding as a result of these benign tumors. The Company plans to request a Type C meeting after all the subjects have experienced the menstrual event following the first course of treatment. Assuming enrollment proceeds according to plan, the Company believes it can schedule a Type C meeting with the FDA around year end 2015. The purpose of this meeting will be to discuss the overall FDA proposed size of the safety database required for an NDA."
Anticipated FDA event • Trial initiation date • Uterine Leiomyoma
November 04, 2013
Repros receives FDA guidance for Proellex low dose oral uterine fibroid clinical program
(Repros Press Release)
- "Repros Therapeutics...has received guidance from the FDA regarding its clinical program for low dose oral Proellex in the treatment of uterine fibroids. The Company currently has three open INDs for Proellex: 70,535 - oral treatment of fibroids STATUS: Full Clinical Hold; 76,631 — oral treatment for endometriosis STATUS: Partial Clinical Hold and in Phase 2; 112,576 — vaginal treatment for fibroids STATUS: Initiating Phase 2b. The Company will use the same design for the vaginal Phase 2b study and expects to start the two studies in early 2014."
Anticipated new trial • FDA event • Uterine Leiomyoma
April 12, 2016
Repros reports positive clinical data for vaginal Proellex in women with severe menstrual bleeding due to uterine fibroids
(Repros Press Release)
- P2, N=42; NCT02323646; Sponsor: Repros Therapeutics; "Repros Therapeutics...today reported that vaginal administration of Proellex ® at doses of both 6 and 12 mg achieved significant reduction in excessive menstrual bleeding, the key symptom of uterine fibroids....At baseline, the mean amount of blood lost for one menstrual cycle was 255 mL, 274 mL and 238 mL for each arm, respectively. Once both the vaginal and oral studies complete both 18 week courses of treatment the Company plans to request an end of Phase 2 meeting with the FDA to jointly discuss plans for Phase 3. Low dose oral data from a comparable study to be reported in Q2 2016."
Anticipated clinical data • Anticipated FDA event • P2b data • Uterine Leiomyoma
August 06, 2016
Repros: Pipeline Update
(Repros)
- Anticipated completion of phase 2 vaginally administered trial (NCT02323646) for uterine fibroids in Q1 2017; Anticipated completion of phase 2 orally administered trial (NCT02301897) for uterine fibroids in Q2 2017; Anticipated completion of phase 2 orally administered trial (NCT01728454) for endometriosis in Q2 2017
Anticipated trial completion date • Endometriosis • Uterine Leiomyoma
January 04, 2012
Repros' IND for Proellex-V accepted by the FDA
(Repros)
- Repros Therapeutics announced its IND for Proellex-V, or vaginally delivered Proellex for the purpose of significant fibroid size reduction and symptom elimination with the goal of avoiding surgery, has been accepted by FDA; Repros expects the P2 (N=36) ZPV-200 study to be completed in 2012 and anticipates to initiate P3 study
Anticipated P2 completion • Anticipated P3 trial initiation • IND submission
May 22, 2013
FDA recommends running phase 2b trial of Proellex-V in the treatment of severe menstrual bleeding associated with uterine fibroids
(Repros)
- "Repros...has met with the FDA regarding the clinical development of Proellex-V... in the treatment of uterine fibroids... the Pictorial Blood Loss Assessment (PBAC) was identified as the key primary endpoint; If the Company proposes a label that includes a claim based on patient reported outcome (PRO), such as bulk symptoms or quality of life, the PRO must be validated before the start of Phase 3...The study will start in the latter half of this year and results are expected in mid 2014. NDA submission is expected in 2016."
Anticipated NDA • Anticipated new P3 trial • Anticipated P3 data • FDA event • Uterine Leiomyoma
April 23, 2016
Repros: Clinical Trial Update
(Repros)
- Anticipated data from the second course of treatment in P2b trial (NCT02323646) for uterine fibroids by Q3 2016
Anticipated P2b data • Uterine Leiomyoma
November 12, 2015
Repros Therapeutics completes randomization of phase 2b study of vaginal Proellex in women with symptomatic uterine fibroid bleeding
(GlobeNewswire)
- "Repros Therapeutics...today announced it has completed randomization for its Phase 2b study of Proellex® in the treatment of women suffering with symptomatic uterine fibroids. In addition, subsequent to discussion with the FDA, Repros is collecting an assessment of blood loss by a validated alkaline hematin method at baseline and during off-drug intervals. At baseline menses women were required to exhibit > 80 ml of blood loss by that method to be enrolled. The Company expects to have topline results from the study of the subjects' first four-month course of treatment during the second quarter of 2016. A sister study using low doses of oral Proellex® in similar women has completed screening and should be fully randomized before the end of January 2016."
Anticipated P2b data • Enrollment status • Uterine Leiomyoma
April 05, 2013
Repros: BioCentury Future Leaders in the Biotech Industry Conference
(Repros)
- Anticipated end of Phase 2 meeting with FDA for vaginal uterine fibroids at end of May 2013; Anticipated initiation of P3 trial for vaginal uterine fibroids in Q3 2013; Anticipated initiation of P2 trial of low dose oral formulation for uterine fibroids by Q4 2013
Anticipated FDA event • Anticipated new P2 trial • Anticipated new P3 trial • Anticipated trial initiation date • Uterine Leiomyoma
November 15, 2012
Lazard Capital Markets Healthcare Conference
(Repros)
- Anticipated patent life for chronic relief of uterine fibroid symptoms, fibroid debulking and endometriosis by mid-2020
Anticipated patent • Endometriosis • Uterine Leiomyoma
July 23, 2012
Repros' Proellex(R)-V shows consistent efficacy in uterine fibroids phase 2 study
(Repros)
- P2, N=36; NCT01451424; At the end of four months of treatment with Proellex 12 mg, all 7 women stopped menstruating and all reported a PBAC score of 0 (p=0.002); The mean UFSQOL score at baseline was 43.8 and at the end of four months the mean score was 1.33 (p=0.001); Repros will complete enrollment by the end of this month; Company anticipates full clinical results at or around year end; End of phase 2 meeting with FDA projected for Q1 2013 with advancement to phase 3 thereafter
Anticipated enrollment status • Anticipated FDA event • Anticipated new P3 trial • Anticipated P2 data • P2 data • Endometriosis
November 15, 2012
Lazard Capital Markets Healthcare Conference
(Repros)
- Anticipated initiation of P2 trial of low dose oral formulation for uterine fibroids and endometriosis by Q4 2012; Anticipated data from P2 trial in vaginal uterine fibroids in Q4 2012
Anticipated new P2 trial • Anticipated P2 data • Endometriosis • Uterine Leiomyoma
November 13, 2012
Repros presents Androxal(R) and Proellex(R) clinical updates at The Lazard Capital Markets 9th Annual Healthcare Conference
(Globenewswire)
- "The Company has initiated the first clinical site for the Phase 2 low dose oral study of Proellex® in the treatment of severe endometriosis and expects to commence enrollment shortly. The Company expects to complete enrollment of the 90 subject, 4 month active dosing trial in the second quarter of 2013 and release results during the fourth quarter of that year"..."The Company has reviewed the preliminary results from the women that have completed dosing with Proellex®-V at 3, 6 and 12 mg. The 12 mg dose achieved statistically significant improvement in menstrual bleeding, uterine fibroid symptoms and reduction in fibroid volume"...
Anticipated enrollment status • Anticipated P2 data • Clinical data • Endometriosis • Uterine Leiomyoma
February 12, 2014
Repros: BIO CEO & Investor Conference
(Repros)
- Anticipated initiation of P2b trial for uterine fibroids in Q2 2014
Anticipated new P2b trial • Anticipated trial initiation date • Uterine Leiomyoma
April 30, 2012
Repros' Proellex-V clears important hurdle in uterine fibroid program
(Market Watch)
- P2, N=36; ZPV-200; Statistical significance (p<0.05) was seen in a pair-wise comparison of the 6 women from both the perspective of reduction in menstrual bleeding using the Pictorial Blood Loss Assessment Chart and a reduction in overall uterine fibroid symptoms as determined by the Uterine Fibroid Symptom Quality of Life Survey; Trial results is expected in the Q4 2012; Company intends to request an end of P2 meeting with the FDA to commence P3 studies late this year or early next year
Anticipated FDA meeting • Anticipated P3 trial initiation • Anticipated trial results • P2 interim data • Uterine Leiomyoma
December 03, 2012
Safety, pharmacokinetics and efficacy of Proellex (telapristone acetate) administered vaginally in the treatment of premenopausal women with uterine fibroids who have completed ZPV-200
(clinicaltrials.gov)
- P2, N=40; Sponsor: Repros; Enrolling by invitation; New P2 trial.
New P2 trial • Uterine Leiomyoma
November 14, 2013
The antiprogestin telapristone shrinks fibroids when when orally or as a vaginal suppository
(COGI 2013)
- Abstract # O105; P2, N=40; Sponsor: Repros Therapeutics; NCT01739621; "Fibroid volume reduction was significant for the 12mg dose as compared to either the 3mg or 6mg dose groups (p = 0.002, and p = 0.01, respectively.) Women taking the 12mg vaginal dose experienced a reduction in PBAC (85 + 25%), in UFSQOL (79 + 32%), and a change in fibroid volume (28 + 13 %.) Of those taking the 12mg dose 58% ceased menstruation whereas, only 18% of the 3mg and 6mg dose groups did so. It was unexpected that the 24mg dose was not more than/as effective as the 12mg dose."
P2 data • Uterine Leiomyoma
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