On May 16, 2019 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the first quarter ended March 31, 2019 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, MAY 16, 2019, View Source [SID1234536402]).

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"During the first quarter, we continued to execute on our strategic initiatives to build our DNAbilize technology and advance our clinical development programs. We were delighted to present data from preclinical studies supporting the potential of BP1003, a novel liposome-incorporated STAT3 oligodeoxynucleotide inhibitor for the treatment of pancreatic cancer, non-small cell lung cancer (NSCLC) and acute myelogenous leukemia (AML) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting before an audience of world-leading oncologists," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "We look forward to completing Investigational New Drug (IND) enabling studies in 2019 through early 2020, and to file an IND application for a Phase 1 study of BP1003 for the treatment of pancreatic cancer in 2020."

Recent Corporate Highlights

·Presented Preclinical Data at American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019. In April 2019, Bio-Path presented data from preclinical studies supporting the potential of BP1003, a novel liposome-incorporated STAT3 oligodeoxynucleotide inhibitor, for the treatment of pancreatic cancer, non-small cell lung cancer (NSCLC) and acute myelogenous leukemia (AML). These data were presented in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, GA.
·Raised $21.3 Million During the First Quarter. In March 2019, Bio-Path issued 712,910 shares of its common stock at a price of $25.95 per share, for gross proceeds of approximately $18.5 million in one transaction. In addition, Bio-Path completed two smaller offerings during the first quarter.

Financial Results for the First Quarter Ended March 31, 2019

·The Company reported a net loss of $1.5 million, or $0.89 per share, for the three months ended March 31, 2019, compared to a net loss of $1.9 million, or $3.38 per share, for the three months ended March 31, 2018.

·Research and development expenses for the three months ended March 31, 2019 decreased to $0.4 million, compared to $0.9 million for the three months ended March 31, 2018 primarily due to decreased clinical trial expenses as we modified operations between Stage 1 and Stage 2 of our Phase 2 clinical trial in AML to include venetoclax combination treatment with prexigebersen.

·General and administrative expenses for the three months ended March 31, 2019 increased to $1.1 million, compared to $1.0 million for the three months ended March 31, 2018 primarily due to increased legal fees and insurance costs.

·As of March 31, 2019, the Company had cash of $19.3 million, compared to $1.0 million at December 31, 2018. Net cash used in operating activities for the three months ended March 31, 2019 was $2.0 million compared to $1.7 million for the comparable period in 2018. Net cash provided by financing activities for the three months ended March 31, 2019 was $20.3 million.

Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these first quarter 2019 financial results and to provide a general update on the Company. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to the conference ID 4956638. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.

On May 16, 2019 Amgen (NASDAQ:AMGN) reported that it will present at the RBC Health Care Conference at 8:30 a.m. ET and at the UBS Global Healthcare Conference at 2 p.m. ET on Tuesday, May 21, 2019, in New York City. Elliott M. Levy, M.D., senior vice president of Global Development at Amgen, will present at both conferences (Press release, Amgen, MAY 16, 2019, View Source;p=RssLanding&cat=news&id=2398945 [SID1234536401]). Live audio of the presentation can be accessed from the Events Calendar on Amgen’s website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen’s website for at least 90 days following the event.

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On May 16, 2019 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") reported that an abstract pertaining to its lead product candidate, Iomab-B, which is being studied in the pivotal Phase 3 SIERRA study, will be presented via poster at the 2019 ASCO (Free ASCO Whitepaper) or American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting that is being held from May 31st – June 4th at McCormick Place, in Chicago (Press release, Actinium Pharmaceuticals, MAY 16, 2019, View Source [SID1234536400]). The data to be presented at ASCO (Free ASCO Whitepaper) is a new analysis from the first 25% of patients enrolled in the SIERRA trial highlighting that by day 3 after Iomab-B administration, patients had a 98% median reduction in peripheral blasts and 100% reduction in blasts by day 8. This significant and rapid reduction in blasts occurred with patients receiving only a single therapeutic infusion of Iomab-B and no other pre-transplant conditioning. As a result, patients had significantly lower circulating leukemia burden prior to their BMT or Bone Marrow Transplant with all patients that received a therapeutic infusion of Iomab-B having robust engraftment despite active disease prior to Iomab-B conditioning.

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(PRNewsfoto/Actinium Pharmaceuticals, Inc.)

Details of the presentation are as follows:

Title: Rapid reduction of peripheral blasts in older patients with refractory acute myeloid leukemia (AML) using reinduction with single agent anti-CD45 targeted iodine (131I) apamistamab [Iomab-B] radioimmunotherapy in the phase III SIERRA trial

Presenter: Ben Kent Tomlinson, MD, Adult Hematologic and Stem Cell Transplant Section, Seidman Cancer Center, University Hospitals Case Medical Center (Cleveland, OH)

Date: Monday, June 3, 2019

Time: 8:00 AM – 11:00 AM Central Daylight Time

Location: Hall A, Poster Board #423, Abstract #7048

Dr. Mark Berger, Actinium’s Chief Medical Officer, said, "We are pleased to have the opportunity to present additional information on our lead candidate Iomab-B at ASCO (Free ASCO Whitepaper). Iomab-B is an important therapeutic candidate and the SIERRA trial is the only Phase 3 trial to offer potentially curative BMT for older patients with active, relapsed or refractory acute myeloid leukemia. While Iomab-B has the potential to be a best-in-class bridge to transplant its profound anti-leukemic and re-induction capabilities must also be noted. Importantly, for the first time, this poster will demonstrate Iomab-B’s effect as a single agent to reduce patients’ circulating leukemia burden, which we find highly encouraging and link to the successful engraftment rates that have been observed in the SIERRA trial to date."

The abstract, which can be accessed on the ASCO (Free ASCO Whitepaper) iPlanner website (click here), presents data on 16 patients that had circulating peripheral blasts including 7 patients originally randomized to receive Iomab-B and 9 patients who crossed over from the control arm to receive Iomab-B after conventional care (salvage chemotherapy) failed to produce a complete remission. As reported in an oral presentation at ASH (Free ASH Whitepaper) 2018 (click here) and a late-breaking oral presentation TCT 2019 (click here), all patients receiving a therapeutic dose of Iomab-B in the SIERRA trial, either directly or via crossover, achieved successful engraftment without delay and donor chimerism by day 100 post-transplant without delay.

About Iomab-B

Iomab-B is an ARC or Antibody Radiation-Conjugate comprised of the anti-CD45 antibody apamistamab and the radioisotope iodine-131 that is intended to be a re-induction and conditioning agent prior to a BMT or bone marrow transplant. Iomab-B was developed at the Fred Hutchinson Cancer Research Center and has been studied in over 300 patients in multiple hematologic indications across 12 clinical trials in addition to the ongoing SIERRA study in older patients with active, relapsed or refractory AML or Acute Myeloid Leukemia prior to patients receiving an allogeneic BMT or bone marrow transplant. Iomab-B is Actinium’s lead targeting conditioning ARC in its multi-target, multi-indication targeted conditioning pipeline that includes the Iomab-B and Actimab-MDS programs for BMT and the Iomab-ACT program that will study a lower dose of Iomab-B for lymphodepletion prior to CAR-T and other cellular therapies.

On May 16, 2019 Allergan plc (NYSE: AGN) reported that Chairman and CEO Brent Saunders will participate in a fireside chat at the Bernstein 35th Annual Strategic Decisions Conference in New York, NY (Press release, Allergan, MAY 16, 2019, View Source(2) [SID1234536397]). The presentation will begin at 9:00 a.m. Eastern Time on Thursday, May 30, 2019.

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The presentation will be webcast live and can be accessed on Allergan’s Investor Relations website at View Source;. The webcast can also be accessed through the following URL: View Source;

An archived version will be available within approximately one hour of the live presentation and can be accessed at the same location for 180 days.

On May 16, 2019 Novartis reported that it will present data from across its oncology portfolio at the upcoming 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), taking place May 31-June 4 in Chicago; and the 24th Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), scheduled for June 13-16 in Amsterdam (Press release, Novartis, MAY 16, 2019, View Source [SID1234536396]). The more than 100 abstracts to be presented underscore Novartis’ relentless commitment to addressing unmet needs in cancer and hematology through innovation and research. Data will focus on a range of disease areas, including breast cancer, lung cancer, melanoma and sickle cell disease, as well as leukemias, other hematologic disorders and solid tumors.

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"We are excited to share the latest information about our transformative therapies in cancer and serious blood disorders at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) this year," said Susanne Schaffert, CEO, Novartis Oncology. "New data will showcase our scientific and patient-focused prowess across a range of the most difficult-to-treat diseases in the world."

Novartis data at the 2019 ASCO (Free ASCO Whitepaper) Annual Congress will highlight the following:

Kisqali overall survival results, and additional data on treatment sequencing and patient reported outcomes in HR+/HER2- advanced breast cancer:

Phase III MONALEESA-7 trial of premenopausal patients with HR+/HER2- advanced breast cancer (ABC) treated with endocrine therapy ± ribociclib: Overall survival (OS) results [Abstract # LBA1008; Oral presentation: Tuesday, June 4, 11:57 AM CDT]
Interim results in the full population from CompLEEment-1, a phase 3b study of ribociclib and letrozole as first-line therapy for advanced breast cancer in an expanded population [Abstract #1041; Sunday, June 2, 8:00 AM CDT]
Alpelisib (ALP) + endocrine therapy (ET) in patients with PIK3CA-mutated hormone-receptor positive (HR+), human epidermal growth factor-2-negative (HER2-) advanced breast cancer (ABC): First interim BYLieve results [Abstract #1040; Sunday, June 2, 8:00 AM CDT]
Patient-reported outcomes (PROs) in patients with PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) advanced breast cancer (ABC) from SOLAR-1 [Abstract #1039; Sunday, June 2, 8:00 AM CDT]
Alpelisib (ALP) + fulvestrant (FUL) in patients with PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) advanced breast cancer (ABC): SOLAR-1 results by therapy line and endocrine therapy resistance (ETR) [Abstract #1038; Sunday, June 2, 8:00 AM CDT]
NATALEE: Phase 3 study of ribociclib (RIBO) + endocrine therapy (ET) as adjuvant treatment in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (EBC) [Abstract #TPS597; Sunday, June 2, 8:00 AM CDT]
First-line ribociclib plus letrozole for postmenopausal women with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC): MONALEESA-2 long-term safety results [Abstract #1078; Sunday, June 2, 8:00 AM CDT]
Continuous dosing ribociclib, everolimus, exemestane in HR+ and HER2- advanced breast cancer post-progression on a CDK4/6 inhibitor [Abstract #1016; Sunday, June 2, 8:00 AM CDT, Poster discussion: 11:15 AM CDT]
In-depth gene expression analysis of premenopausal patients with HR+/HER2- advanced breast cancer (ABC) treated with ribociclib containing therapy in the Phase III MONALEESA-7 trial [Abstract #1018; Sunday, June 2, 11:15 AM CDT, Poster discussion: 11:30 AM CDT]
Long-term and new analyses of the Tafinlar+Mekinist COMBI trials in melanoma:

Five-year analysis of dabrafenib plus trametinib (D+T) in patients with BRAF V600-mutant unresectable or metastatic melanoma confirms long-term benefit [Abstract #9507; Oral presentation: Tuesday, June 4, 11:57 AM CDT]
The anti-PD-1 antibody spartalizumab (S) in combination with dabrafenib (D) and trametinib (T) in previously untreated patients with advanced BRAF V600-mutant melanoma: updated efficacy and safety from parts 1 and 2 of COMBI-i [Abstract #9531; Monday, June 3, 1:15 PM CDT]
Circulating tumor DNA (ctDNA) kinetics to predict survival in patients with unresectable or metastatic melanoma treated with dabrafenib (D) or D + trametinib (T) [Abstract #9510; Oral presentation: Saturday, June 1, 3:24 PM CDT]
Tumor microenvironment (TME), longitudinal biomarker changes, and clinical outcome in patients with advanced BRAF V600-mutant melanoma treated with 1st-line spartalizumab (S) + dabrafenib (D) + trametinib (T) [Abstract #9515; Monday, June 3, 1:15 PM CDT; Poster discussion: 4:30 PM CDT]
Association between baseline disease characteristics and relapse-free survival (RFS) in patients with BRAF V600-mutant resected stage III melanoma treated with adjuvant dabrafenib (D) + trametinib (T) or placebo (PBO) [Abstract #9582; Monday, June 3, 1:15 PM CDT]
Results from GEOMETRY study investigating capmatinib (INC280) in NSCLC:

Capmatinib (INC280) in METVAR.ex14-mutated advanced non-small cell lung cancer (NSCLC): Efficacy data from the phase II GEOMETRY mono-1 study [Abstract #9004; Oral presentation: Monday, June 3, 9:12 AM CDT]
Analyses on treatment of advanced solid tumors and hematologic malignancies with spartalizumab (PDR001) in combination with other agents:

Phase Ib study of MIW815 (ADU-S100) in combination with spartalizumab (PDR001) in patients with advanced/metastatic solid tumors or lymphoma [Abstract #2507; Oral presentation: Sunday, June 2, 10:12 AM CDT]
Phase II, open-label study of spartalizumab (PDR001) and LAG525 for patients with advanced solid tumors and hematologic malignancies [Abstract #2553; Saturday, June 1, 8:00 AM CDT]
A study evaluating Kymriah (tisagenlecleucel)*** in follicular lymphoma:

ELARA: A Phase 2, single-arm, multicenter, open-label trial investigating the efficacy and safety of tisagenlecleucel in adult patients with refractory/relapsed follicular lymphoma (r/r FL) [Abstract #TPS7573; Monday, June 3, 8:00 AM CDT]
Long-term treatment-free remission (TFR) data, after Tasigna treatment discontinuation, in patients with CML:

ENESTop 192-week results: treatment-free remission (TFR) in patients with chronic myeloid leukemia in chronic phase (CML-CP) after stopping second-line (2L) nilotinib (NIL) [Abstract #7005; Oral presentation: Saturday, June 1, 4:24 PM CDT]
Treatment-free remission (TFR) following frontline (1L) nilotinib (NIL) in patients with chronic myeloid leukemia in chronic phase (CML-CP): 192-week data from the ENESTfreedom study [Abstract #7013; Monday, June 3, 1:15 PM CDT, Poster discussion: 4:30 PM CDT]
Additional data presented at ASCO (Free ASCO Whitepaper) include:

The CANOPY Program: Canakinumab in patients with non-small cell lung cancer (NSCLC) [Abstract #TPS9124; Sunday, June 2, 8:00 AM CDT]
CANOPY-A: A Phase 3 study of canakinumab as adjuvant therapy in patients with surgically resected non-small cell lung cancer (NSCLC) [Abstract #7013; Sunday, June 2, 8:00 AM CDT]
Advanced Accelerator Applications, a Novartis company and leader in nuclear medicine theragnostics, will present additional analyses from the NETTER-1 study evaluating Lutathera (lutetium Lu 177 dotatate)**** in patients with progressive midgut neuroendocrine tumors:

Analyses of patient diaries in the NETTER-1 study of 177Lu-DOTATATE versus high-dose octreotide in progressive midgut neuroendocrine tumors [Abstract #4111; Monday, June 3, 8:00 AM CDT]
Sandoz, a Novartis division, the pioneer and global leader in biosimilars, will present data for the company’s biosimilar pegfilgrastim:

Cost-minimization analysis for biosimilar pegfilgrastim in the prophylaxis of chemotherapy induced (febrile) neutropenia and expanded access based on budget neutral basis [Abstract #6645; Saturday, June 1, 1:15 PM CDT]
Additional data from Sandoz to be featured online by ASCO (Free ASCO Whitepaper) include:

A large multi-center, randomized, double-blind, crossover study in healthy volunteers, comparing pharmacokinetics and pharmacodynamics of Sandoz proposed biosimilar pegfilgrastim with EU and US reference pegfilgrastim [online only]
Novartis data at the 2019 EHA (Free EHA Whitepaper) Annual Congress will highlight the following:

Retrospective data for investigational compound crizanlizumab (SEG101):

SUCCESSOR: A multicenter retrospective non-interventional follow-up study in patients with sickle cell pain crises who previously participated in the SUSTAIN trial in the United States SUCCESSOR study [Abstract #S853; Oral presentation: Saturday, June 15, 11:45 AM CET]
Expert consensus paper on tapering and discontinuation of TPO-RAs and additional results of worldwide ITP impact survey:

Tapering and discontinuation of thrombopoietin receptor agonists in ITP: Expert consensus opinions [Abstract #PF709; Friday, June 14, 5:30 PM CET]
Physicians’ perceptions on causes of primary and secondary ITP and leading causes of misdiagnosis: Results from the ITP World Impact Survey (I-WISh) [Abstract #PF712; Friday, June 14, 5:30 PM CET]
Patient perceptions on splenectomy outcomes: Results from the ITP World Impact Survey (I-WISh) [Abstract #PF714; Friday, June 14, 5:30 PM CET]
Differences on perceptions on treatment approaches between physicians and ITP patients: Results from the ITP World Impact Survey (I-WISh) [Abstract #PF711; Friday, June 14, 5:30 PM CET]
Data on the investigational compound asciminib (ABL001) in combination with other tyrosine kinase inhibitors in previously treated CML patients:

Combination therapy using asciminib plus imatinib (IMA) in patients with chronic myeloid leukemia (CML): Results from a Phase 1 study [Abstract #S883; Oral presentation: Saturday, June 15, 4:30 PM CET]
Combination of asciminib plus nilotinib (NIL) or dasatinib (DAS) in patients with chronic myeloid leukemia: Results from a Phase 1 study [Abstract #S884; Oral presentation: June 15, 4:30 PM CET]
Data analyses with a 3.7-year follow-up for Tasigna TFR in CML:

Durability and impact on quality of life of treatment-free remission (TFR) in patients with chronic myeloid leukemia after stopping frontline (1L) nilotinib: [Abstract #PF409; Friday, June 14, 5:30 PM CET]
ENESTop 192-week results: Durability and impact on quality of life of TFR second-line (2L) nilotinib [Abstract #PF411; Friday, June 14, 5:30 PM CET]
Abstracts analyzing the safety and efficacy of Kymriah in acute lymphoblastic leukemia, and on regrading of adverse events in diffuse large B-cell lymphoma:

Tisagenlecleucel appears effective and safe in pediatric and young adult patients with relapsed/refractory acute lymphoblastic leukemia with high-risk cytogenetic abnormalities [Abstract #S1618; Oral presentation: Sunday, June 16, 8:15 AM CET]
Analyses of cytokine release syndrome and neurotoxicity by age and lymphodepleting chemotherapy use in adults with relapsed or refractory diffuse large B-cell lymphoma treated with tisagenlecleucel [Abstract #PF305; Friday, June 14, 5:30 PM CET]
Safety and efficacy of Jakavi (ruxolitinib)***** in myelofibrosis (MF) and anemia, and additional results from a large-scale survey on the impact of myeloproliferative neoplasms:

Safety and efficacy of ruxolitinib (RUX) in patients with myelofibrosis (MF) and anemia (HB <10 g/dl): Results at week 24 of the REALISE trial [Abstract #PS1465; Saturday, June 15, 5:30 PM CET]
Impact of myeloproliferative neoplasms (MPNs) and perceptions of treatment goals amongst physicians and patients in 6 countries: An expansion of the MPN Landmark Survey [Abstract #PF681; Friday, June 14, 5:30 PM CET]
New and updated data evaluating the efficacy and safety of Rydapt (midostaurin) in patients with acute myeloid leukemia (AML) and different genetic mutational status:

RATIFY post-hoc analyses:
Prognostic and predictive impact of NPM1/FLT3-ITD genotypes as defined by 2017 European LeukemiaNet (ELN) risk categorization from randomized patients with acute myeloid leukemia (AML) treated within the international RATIFY Study (ALLIANCE 10603) [Abstract #PF260; Friday, June 14, 5:30 PM CET]
Genetic landscape of FLT3-mutated acute myeloid leukemia (AML) patients treated within the RATIFY Trial: CALGB 10603 (ALLIANCE) [Abstract #PS968; Saturday, June 15, 5:30 PM CET]
RATIFY: Prognostic impact of FLT3 tyrosine kinase domain (TKD) and NPM1 mutation status in patients with newly diagnosed acute myeloid leukemia (AML) treated with midostaurin + standard chemotherapy [Abstract #PF256; Friday, June 14, 5:30 PM CET]
Throughout the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting and EHA (Free EHA Whitepaper) Annual Meeting, Novartis will host dedicated content on Twitter, Facebook, and LinkedIn, featuring leader and patient insights and perspectives on the emerging trends in cancer care and research.

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