International, Multi-Center, Open-label, Treatment Extension Study of Iniparib as Monotherapy or in Combination Chemotherapeutic Regimens in Cancer Patients Who Have Derived Clinical Benefit From Iniparib Following Completion of a Phase 1, 2 or 3 Parental Study

The purpose of this study is to assess the safety and tolerability of iniparib administered as monotherapy or in combination regimens in patients previously treated with iniparib in a clinical study and who have derived clinical benefit after completion of the parental study's objectives.

Start Date01 May 2012

Sponsor / Collaborator

Sanofi

NCT01455532

/ CompletedPhase 1

A Phase 1/1b Dose Escalation Study Evaluating Iniparib (BSI201/SAR240550) as a Single Agent and in Combination With Chemotherapeutic Regimens in Patients With Solid Tumors

Primary Objective:
To assess the safety and the maximum tolerated dose(MTD) of iniparib as a single agent and in combination with chemotherapeutic regimens in patients with advanced solid tumors that are refractory to standard therapy.
Secondary Objectives:
To assess the antitumor effect of iniparib (per Response Evaluation Criteria in Solid Tumors [RECIST]) Version 1.1 in patients with measurable disease.
To characterize iniparib (and its metabolites, if possible) pharmacokinetics.
Based on data generated by Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

Start Date01 Nov 2011

Sponsor / Collaborator

Sanofi

NCT01213381

/ CompletedPhase 1

A Phase I Study Evaluating the Safety and Pharmacokinetics of SAR240550 Administered Twice Weekly in Patients With Advanced Solid Tumors.

Primary Objective:
- To determine a dose of SAR240550 to be further studied in combination with chemotherapy regimens
Secondary Objectives:
To determine the dose limiting toxicity (DLT) of SAR240550 and SAR240550 in combination with chemotherapy regimen (gemcitabine and carboplatin
To assess safety profiles: significant laboratory changes and adverse events (AEs)
To make a preliminary assessment of antitumor effect in study subjects per Response Evaluation Criteria in Solid Tumors (RECIST) with measurable disease
To characterize SAR240550 and metabolites, 4-iodo-3-amino benzamide (IABM) and 4-iodo-3-amino-benzoic acid (IABA), pharmacokinetics
To collect blood samples for glutathione S-transferase (GST) genotypes at baseline)
Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

Start Date01 Sep 2010

Sponsor / Collaborator

Sanofi

100 Clinical Results associated with Iniparib

100 Translational Medicine associated with Iniparib

100 Patents (Medical) associated with Iniparib

163

Literatures (Medical) associated with Iniparib

01 May 2025·Contemporary Clinical Trials

Restricted mean survival time based on Wu-Kolassa estimator compared to Kaplan-Meier estimator

Article

Author: Dong, Ning ; Wu, Yaoshi ; Kolassa, John

OBJECTIVE:

The purpose of the paper is to introduce the Wu-Kolassa estimator (WKE) and the RMST based on it for its less biased estimation and substantial power gain, compared to the Kaplan-Meier estimator (KME), to researchers working in medical and health sciences to evaluate and compare patient survival times.

RESULTS:

The seven numerical studies showed that the power gain in WKE-based RMST analysis can reach more than 80 %, depending on the size of the study and the trend of failure rate. For the phase III study of iniparib plus gemcitabine and carboplatin (GCI) versus gemcitabine and carboplatin (GC) in patients with metastatic triple-negative breast cancer, GCI is superior to GC demonstrated by WKE-based RMST analysis (point estimate of treatment difference in RMST = 0.807; 95 % CI: 0.0214 to 1.592, 1.5 times higher than the estimate based on KME = 0.542; 95 % CI: -0.385 to 1.470). For the phase III trial that studied ovarian suppression (os) with tamoxifen or exemestane, tamoxifen plus os is superior to tamoxifen alone using WKE-based RMST (point estimate of difference = 0.228; 95 % CI: 0.016 to 0.439, more than 2-fold higher than the estimated difference based on KME = 0.113; 95 % CI: -0.008 to 0.234).

CONCLUSIONS:

The Wu-Kolassa estimator is superior to the Kaplan-Meier estimator as it reduces the estimation bias and increases the power in the RMST analysis when the censoring rate is high or when the reference group has more censoring data than the test group.

01 Apr 2025·JOURNAL OF BIOLOGICAL CHEMISTRY

Duplexed CeTEAM drug biosensors reveal determinants of PARP inhibitor selectivity in cells

Article

Author: Alam, Seher ; Rotili, Dante ; Fabbrizi, Emanuele ; Lovric, Alen ; Altun, Mikael ; Pires, Maria J ; Valerie, Nicholas C K

Poly (ADP-ribose) polymerase (PARP) inhibitors (PARPi) targeting PARP1 and PARP2 have revolutionized cancer therapy by selectively killing cancer cells with defective DNA repair. However, achieving PARP1 or PARP2-selective inhibitors is difficult due to structural homology. Selectivity profiling is typically done with purified proteins, but these lack the complexity of intracellular environments and could therefore be inaccurate. Here, we duplex PARP1 L713F-GFP and PARP2 L269A-mCherry cellular target engagement by accumulation of mutant (CeTEAM) drug biosensors to systematically characterize binding and cell cycle alterations of 27 PARPi. Our results reveal that most PARPi are equipotent for both PARPs, including the next-generation drug, senaparib. However, benzimidazole carboxamide (niraparib) derivatives demonstrated PARP1-selective tendencies, while phthalazinones (olaparib) favored PARP2. AZD5305, a reported PARP1-selective inhibitor with characteristics of both series, was the exception and appears ∼1600-fold more potent toward PARP1. In agreement with current understanding, we see that trapping-associated S/G2-phase transitions positively correlate with PARP1/2 binding potency, while some potent binders, such as veliparib, did not - likely reflecting their allosteric influence on DNA retention. We also assessed the effect of the PARP1/2 active site component, histone PARylation factor 1, on intracellular PARPi binding and see that its depletion elicits slight deviations in apparent binding potency, while contributing additively to trapping-like phenotypes. The PARP1/2 CeTEAM platform thus provides a structural roadmap for the development of selective PARPi and should facilitate the discovery of targeted therapies. Furthermore, our results highlight that multiplexing CeTEAM biosensors and layered genetic perturbations can systematically profile determinants of intracellular drug selectivity.

17 Jan 2025·ORGANIC LETTERS

Polyfluoroalkanoic Acids as Fluoroalkylating Reagents: Strategy for Direct Access to R_f-Embedded Amides

Article

Author: Kabadwal, Lalit Mohan ; Bera, Atanu ; Haldar, Shuvojit ; Banerjee, Debasis

Herein, we have reported the application of bench stable perfluoroalkanoic acids as fluoro-alkylating reagents in combination with DIB and primary amides for sequential one-pot transformation to R_f-embedded functionalized amides under metal-free conditions. The protocol is tolerant to a range of sensitive functional groups (>33 examples and up to 90% yield), and perfluoro acids. Preliminary mechanistic studies, control experiments, in situ ¹⁹F-NMR analyses, and the synthesis of intermediate species were performed to understand the reaction pathways.

News (Medical) associated with Iniparib

20 Jan 2017

·www.biospace.com

New FDA Report Cites 22 Drugs That Passed Phase II But Crashed and Burned in Phase III

January 20, 2017 By Mark Terry , BioSpace.com Breaking News Staff The Trump administration has indicated plans to reform the U.S. Food and Drug Administration (FDA) “to put greater focus on the need of patients for new and innovative medical products.” So far, it hasn’t selected a commissioner for the FDA, although some of the names suggested, such as Jim O’Neil , a venture capitalist, and Balaji Srinivasan , co-founder of genetics testing company Counsyl , have showed indications that they want to focus on drug safety rather than efficacy, perhaps even cutting the need for in-depth Phase III clinical trials. The FDA just published a study titled, “22 Case Studies Where Phase 2 and Phase 3 Trials Had Divergent Results .” Below are the so-called Hall of Shame drugs that showed promise in Phase II, but failed in Phase III. 1. Bitopertin ( Roche , . For schizophrenia. Failed to improve the negative symptoms of schizophrenia. 2. Bitopertin ( Bristol-Myers Squibb , . For hepatocellular cancer. Failed to improve overall patient survival compared to approved treatment and had unexpected toxicities. 3. Capsaicin Topical Patch, Qutenza ( NeurogesX , ). To treat HIV-associated nerve pain, with previous approval for treatment of shingles-associated nerve pain. Lack of efficacy compared to control groups. 4. Darapladib ( GlaxoSmithKline , .) As an add-on to statins for cardiovascular disease in patients with a prior heart attack. Failed for lack of efficacy, despite promising biomarker evidence in Phase II. 5. Dexmecamylamine ( Targacept , / AstraZeneca , . For add-on treatment of depression. No more effective than placebo in Phase III trials for treatment of depression. 6. Exhale Drug-Eluting Stent ( Broncus Technologies ). For reduction of shortness of breath in emphysema patients. Statistically significant results in Phase II, but failed to improve lung function or symptoms in Phase III. 7. Experimental HSV-2 Vaccine ( Chiron , now Novartis Vaccines & Diagnostics ). To prevent genital herpes. Positive biomarker results in Phase II, did not prevent genital herpes in Phase III. 8. Gluatmic Acid Decarboxylase Vaccine ( Diamyd Medical ). For the preservation of insulin secretion for patients with recent-onset type 1 diabetes. Promising results in Phase II, but in the Phase III trial, did not improve pancreatic function or clinical outcomes. 9. Imiquimod, Aldara 5% Cream ( 3M , . To treat molluscum contagiosum (MC) lesions in children. Was approved to treat external anogenital warts. Showed promising Phase II results, but in Phase III did no better than placebo. 10. Iniparib ( Sanofi , . As an add-on treatment of triple negative breast cancers. Showed promising tumor response and survival in Phase II, but in Phase III did not improve survival. 11. Lithium ( King’s College London , UK). Already a treatment for bipolar disorders, was being tested as an add-on treatment to delay disease progression of amyotrophic lateral sclerosis. Showed positive effects on disease progression and survival in Phase II, but in Phase III did not improve survival, health status or quality of life. 12. MAGE-A3 Vaccine ( GlaxoSmithKline , . For non-small cell lung cancer (NSCLC). Proof of concept trial was promising, but showed no clinical benefit compared to placebo in Phase III. 13. NicVAX Vaccine ( Nabi Biopharmaceuticals , . For smoking cessation. Promising Phase II, but in Phase III the abstinence rate was similar to placebo. 14. Velimogene Aliplasmid, Allovectin-7 ( Vical , . For metastatic melanoma. In Phase II, showed evidence of tumor shrinkage. In Phase III, reduced tumor size in significantly fewer patients than two other marketed drugs. 15. Olanzapine Pamoate, Zyprexa Relprevv ( Eli Lilly , . Evaluated for long-acting injection treatment for schizophrenia. Already approved as an oral short-acting treatment for schizophrenia. In Phase III, identified serious safety risks. 16. Aliskiren, Rasilez, Tekturna ( Novartis , . Evaluated as an add-on treatment for prevention of congestive heart failure (CHF) complications. Previously approved for hypertension. Positive results in an proof of concept study, but in the Phase III trial adding aliskirin to standard therapy, did not cut cardiovascular-related death or CHF re-hospitalization, and showed an increase in kidney failure and low blood pressure. 17. CoStar Drug-Eluting Stent ( Conor Medsystems ). To cut heart attack risk in patients with coronary artery disease. Although approved in Europe and had positive results in a small trial, patients who received it in Phase III trials had worse outcomes than those receiving different stents. 18. Figitumumab ( Pfizer , . Evaluated as an add-on treatment of advanced non-small cell lung cancer (NSCLC). Showed promise in Phase II, but in Phase III failed to improve survival. Also, in one combination with another regimen, increased serious adverse events and deaths. 19. Recombinant Factor VIIa, NovoSeven ( Novo Nordisk , . Evaluated for decrease of intracerebral bleeding and hematoma size in stroke patients. Already approved for hemophilia. Showed positive Phase II results, but in Phase III, patients didn’t show clinical benefits, but did have an increase incidence of serious events compared to patients receiving the placebo. 20. Semagacestat ( Eli Lilly , . For Alzheimer’s disease. Showed promising biomarker results in Phase II, but the Phase III trial was ended early because patients receiving the drug had worsened cognition, worse functional status, and an increased risk of skin cancer. 21. Torcetrapib ( Pfizer , . For the prevention of cardiovascular events in patients with a history of cardiovascular disease or type 2 diabetes. Showed improved cholesterol levels in Phase II trials, but in Phase III it increased mortality and cardiac events compared with placebo. 22. V710 Vaccine (Intercell--now Valneva / Merck , . V710 Vaccine (Intercell (now Valneva)/Merck, MRK). Evaluated as a vaccine to prevent Staphylococcus aureus infection. Showed promise in Phase II, but the Phase III clinical trial was ended early because of lack of efficacy and the potential risk for serious adverse events and death. John Carroll , writing for Endpoints News, writes , “Some on the libertarian side have said they want to simply toss out the gold standard on efficacy and safety altogether, excoriating the old rules of market engagement. That toxic argument raises some important questions about each stage of drug development. And there’s a new report out from the FDA that covers just what you can miss if you cut Phase III out altogether.”

Clinical ResultPhase 3Phase 2VaccineDrug Approval

12 Jul 2016

·www.biospace.com

Sanofi Hunts Other Oncology Companies for Cancer Gold

July 12, 2016 By Mark Terry , BioSpace.com Breaking News Staff It’s not exactly a secret that Paris-based Sanofi is on the prowl for acquisitions to bolster its sagging oncology portfolio. It’s ongoing hostile takeover for the Bay Area’s Medivation is the prime example. The company’s chief scientific officer, Gary Nabel , recently provided some granularity to Sanofi’s interests. He noted to Bloomberg that the French company is looking for approved cancer drugs as well as experimental ones that use new knowledge or techniques. Medivation fits both of those, with its blockbuster Xtandi for prostate cancer, and a PARP inhibitor, talazoparib, in late stage trials for breast cancer patients with BRCA mutations. “One part of the approach is to take mature assets and to maximize value from those,” Nabel told Bloomberg. “Those are late-stage acquisitions. But equally important, it’s looking at early stage developments like PARP inhibitors and others.” Sanofi’s oncology presence has but hurt by patent expirations and generic competition. It also had a notable failure when it acquired the Bay Area’s BiPar Sciences in 2009. The drug it picked up in the deal, BSI-201, didn’t meet its endpoints in 2011. Then the company made a strategic decision that made sense at the time, but didn’t pan out. While many companies began to look at immuno-oncology, such as Merck & Co. and Bristol-Myers Squibb , Sanofi focused on targeted cancer therapies. The poster child for that type of work is Novartis AG ’s Gleevec. Although Gleevec was enormously successful, even revolutionary, that type of work has proven to be a challenge with only a handful of successes. “Unless you were very lucky, and had a very good understanding of the target that you were after in the individual patient,” Nabel told Bloomberg, “the success more broadly was going to be limited.” Perhaps a step too slow, Sanofi tossed $2.2 billion into a deal with Regeneron Pharmaceuticals to push into immuno-oncology, specifically on checkpoint inhibitors targeting PD-1. The two companies have done okay with their new cholesterol medicine, Praluent, progress in cancer has been harder to see. Although an acquisition of Medivation still seems likely, there are hints that Sanofi may be interested in other oncology companies as well. Nabel didn’t provide any specifics, but did say, “There’s innovation externally—late stage, where you pay more, but you get something that’s more defined. Early stage, where you pay less, and you take on more risk. But you can potentially pick up very transformative ideas early on. So we’d like to sample across that whole spectrum.” Others have noted that Sanofi has an interest in the rare disease market as well, and that Vertex Pharmaceuticals and Alexion Pharmaceuticals might be interesting targets. Vertex markets Kalydeco and Orkambi for cystic fibrosis (CF), and has nine pipeline candidates in CF and cancer. Alexion’s focus is rare diseases, with three approved drugs, Sliris to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), Strensiq to treat hypophosphatasia (HPP) and Kanuma to treat lysosomal acid lipase deficiency (LAL-D). Its pipeline is focused on various areas, including hematology, neurology, nephrology, metabolic disorders and inflammatory diseases. There have also been rumors that if the Medivation deal falls through, Sanofi might go go after Novato, California-based BioMarin Pharmaceutical , best known for its failed Duchenne muscular dystrophy drug, Kyndrisa (drisapersen). If it is interested in BioMarin, it would be for rare genetic diseases, which include a pipeline for achondroplasia, CLN2 disease, Hemophilia A and Sanfilippo Syndrome. Already marketed drugs include Vimizim for Morquio A Syndrome, Kuvan for PKU, Naglazyme for MPS VI, Aldurazyme for MPS I, and Firdapse for LEMS.

AcquisitionImmunotherapyDrug Approval

17 Jul 2009

·www.biospace.com

Sanofi-Aventis (France) and BiPar Sciences, Inc. Release: BSI-201 Enters Phase 3 in Metastatic Triple Negative Breast Cancer

PARIS and SOUTH SAN FRANCISCO, Calif., July 17, 2009 (GLOBE NEWSWIRE) -- Sanofi-aventis (EURONEXT:SAN) (NYSE:SNY) and its wholly owned subsidiary, BiPar Sciences, today announced the initiation of the pivotal Phase 3 trial for BSI-201 in combination with chemotherapy in patients with metastatic triple-negative breast cancer (mTNBC), defined by tumors lacking expression of estrogen, progesterone receptors and without over-expression of HER2. BSI-201 is a novel, investigational, targeted therapy which inhibits poly (ADP-ribose) polymerase (PARP1), an enzyme involved in DNA damage repair.

100 Deals associated with Iniparib

External Link

KEGG	Wiki	ATC	Drug Bank
D09913	Iniparib	-	DB13877

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	Phase 3	Belgium	Sanofi	01 May 2012
Solid tumor	Phase 3	Italy	Sanofi	01 May 2012
Solid tumor	Phase 3	Spain	Sanofi	01 May 2012
Metastatic HER2-Negative Breast Carcinoma	Phase 3	United States	Sanofi	01 Jul 2009
Triple Negative Breast Cancer	Phase 2	Germany	Sanofi	01 Sep 2010
Brain metastases	Phase 2	United States	Sanofi	01 Jul 2010
Estrogen receptor-negative breast cancer	Phase 2	United States	Sanofi	01 Jul 2010
HER2-negative breast cancer	Phase 2	United States	Sanofi	01 Jul 2010
progesterone receptor-negative breast cancer	Phase 2	United States	Sanofi	01 Jul 2010
metastatic non-small cell lung cancer	Phase 2	France	Sanofi	01 May 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01033123 \| NCT01033292 (Pubmed)	Phase 2	Recurrent ovarian cancer	-	Iniparib (BSI-201) + Gemcitabine + Carboplatin	tjpzmkvubg(rhuyisdliz) = kynsdnmdbf vsbycaegwc (boccscaucs, 49 - 80) View more	-	30 Jan 2023
NCT01173497 (TBCRC2016) Manual	Phase 2	Triple Negative Breast Cancer \| Brain metastases triple negative	37	Irinotecan Hydrochloride+Iniparib	brantmdipj(xjeebudkyl) = evabbfnkqi rjrcolukwo (ivpuzztycx ) View more	-	18 May 2016
NCT00677079 (Pubmed \| Int J Gynecol Cancer) Manual	Phase 2	Platinum-Resistant Primary Peritoneal Carcinoma \| Ovarian Epithelial Carcinoma \| Fallopian Tube Carcinoma Last line BRCA1 Mutation \| BRCA2 Mutation	12	Iniparib	kufanxwtlp(fxpsmsdgrk) = aehknwbvjp kqspqrsbrp (gemlrqfnza )	Negative	01 Feb 2016
NCT01204125 (SOLTI NeoPARP, Pubmed \| Breast Cancer Res Treat)	Phase 2	Triple Negative Breast Cancer Neoadjuvant	141	Paclitaxel alone	smduxufkhj(hbmzqtezab) = iqkkxfxzrl riqhycakee (fkhfpwegjn ) View more	Negative	01 Nov 2015
	Phase 2	Triple Negative Breast Cancer Neoadjuvant	141	Iniparib + Paclitaxel once-weekly	smduxufkhj(hbmzqtezab) = rbthdqfzkw riqhycakee (fkhfpwegjn ) View more	Negative	01 Nov 2015
NCT00813956 (PrECOG 0105, Pubmed \| J Urol \| J Clin Oncol) Manual	Phase 2	Triple Negative Breast Cancer Neoadjuvant BRCA1 Mutation \| BRCA2 Mutation \| Triple-Negative	80	Gemcitabine+Carboplatin+Iniparib	jbhnlruvuv(pnraesylgz) = cduaqbtzjq jbiqvbgbkl (xvyoomewpz, 27 - 46)	Positive	10 Jun 2015
NCT01086254 (Pubmed \| Ann Oncol)	Phase 2	metastatic non-small cell lung cancer First line	119	Gemcitabine-cisplatin	ylrivbtdbz(ncsjtdiwmb) = vqmnpluugu cyclvqlxce (ldfwxyvfhu, 13.0% - 42.1%) View more	-	01 Nov 2014
NCT01086254 (Pubmed \| Ann Oncol)	Phase 2	metastatic non-small cell lung cancer First line	119	Gemcitabine-cisplatin-iniparib	ylrivbtdbz(ncsjtdiwmb) = vofkhstilt cyclvqlxce (ldfwxyvfhu, 11.9% - 30.4%) View more	-	01 Nov 2014
NCT01173497 (TBCRC 018, ASCO2013)	Phase 2	Triple Negative Breast Cancer	37	Iniparib + Irinotecan	cblkpzdvvj(bclrwygukj) = hshwwpvdtt yxjxlsuude (hqpptxpydn ) View more	-	20 May 2013
NCT00687687 (Pubmed \| Gynecol Oncol)	Phase 2	Uterine Carcinosarcoma	22	Iniparib plus paclitaxel and carboplatin	xlesomewdj(rkrhphaqxd) = pltinviqjn erqqidezni (skgsglslzd, 8.5 - 46.1)	Negative	01 Sep 2012
NCT01033123 (ASCO2011)	Phase 2	Platinum-Sensitive Ovarian Carcinoma	41	Iniparib + GC	gfozrklppa(ejjbmqgsuu) = hqqhlqynye fflfbdqgea (vrpwlwswxh )	-	20 May 2011
NCT01033292 (ASCO2011)	Phase 2	Recurrent Platinum-Resistant Ovarian Carcinoma	48	Iniparib + GC	srfwabqtlc(yhtpmrmojk) = tntsqruznk blrbvhdjqo (ryukvcaxnj ) View more	-	20 May 2011

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