December 2018

Features

Interview: Challenges and Opportunities in Psychiatric Trials

December 31, 2018

In a recent conversation on the current psychiatric clinical trials environment, Mark Opler, MD, chief research officer at WCG-MedAvante-ProPhase, had the opportunity to gather insights from noted clinical psychiatrist and researcher Christoph Correll, MD. Dr. Correll’s work focuses on the identification, characterization and treatment of adults and youths with severe psychiatric disorders. His particular area of expertise is psychopharmacology.

Dr. Opler: Could you tell us what you see as the top three challenges in our current clinical trials environment?

Dr. Correll: Unfortunately, we’ve seen many programs look promising but ultimately fail. The transition from Phase II to Phase III has been particularly difficult, and we need to understand that better. We get signals in smaller trials that are suggestive, but once they go into large explanatory Phase III trials, the results are disappointing.

Pipeline

New Pipeline Updates from Concert, Spiral and Daiichi Sankyo

December 31, 2018

Company Drug/Device Medical Condition Status
Concert Pharmaceuticals CTP-692 schizophrenia Phase I trial initiated enrolling 80 healthy volunteers
Spiral Therapeutics LPT99 inner ear disorders Phase I trial initiated enrolling 32 healthy adult subjects
Daiichi Sankyo Company, Ltd. quizartinib, a FLT3 inhibitor and an MDM2 inhibitor, milademetan (DS-3032) relapsed/refractory FLT3-ITD acute myeloid leukemia (AML) or newly-diagnosed FLT3-ITD AML unfit for intensive chemotherapy Phase I trial initiated enrolling up to 110 subjects in the U.S., EU and Japan
Carmot Therapeutics CT-868 type 2 diabetes Phase I trial initiated enrolling overweight or obese but otherwise healthy volunteers and subjects
Viriom, Inc. VM1500A once monthly injectable HIV Phase I trial initiated enrolling up to 36 HIV-uninfected volunteers in Moscow, Russia
CStone Pharmaceuticals CS1001 advanced solid tumors Phase I trial initiated enrolling subjects in the U.S.
MiNATherapeutics MTL-CEBPA in combination with Sorafenib advanced liver cancer Phase Ib trial initiated enrolling 38 subjects in the U.K., Singapore and Taiwan
Actuate Therapeutics, Inc. 9-ING-41 refractory hematologic malignancies or solid tumors Phase I/II trial initiated
Vedanta Biosciences VE303 recurrent Clostridium difficile infection (rCDI) Phase II trial initiated enrolling up to 146 subjects with a recent diagnosis of rCDI
Hookipa Pharma, Inc. HB-101 cytomegalovirus (CMV) Phase II trial initiated enrolling 150 male and female subjects aged 18 years or older at 35 sites worldwide
Pear Therapeutics, Inc. Pear-004 schizophrenia Phase II trial initiated
Ayala Pharmaceuticals, Inc. AL101 adenoid cystic carcinoma (ACC) bearing Notch activated mutations Phase II trial initiated enrolling subjects at eight sites in the U.S.
Isofol Medical AB arfolitixorin metastatic colorectal cancer (mCRC) Phase III trial initiated enrolling 440 subjects aged 18 years or older
Corbus Pharmaceutical Holdings, Inc. lenabasum dermatomyositis Phase III trial initiated enrolling 150 subjects
Rakuten Aspyrian ASP-1929 recurrent local regional head and neck squamous cell carcinomas (HNSCC) Phase III trial initiated enrolling 275 subjects at 75 sites in the U.S., Europe and Asia
CathWorks FFRangio System multi-vessel coronary artery disease 510(k) clearance granted by the FDA
Retia Medical, LLC Argos Cardiac Output (CO) Monitor cardiac output monitoring 510(k) clearance granted by the FDA
Arch Therapeutics, Inc. AC5 Topical Gel partial and full-thickness wounds 510(k) clearance granted by the FDA
Amgen Nplate (romiplostim) immune thrombocytopenia (ITP) sBLA approval granted by the FDA

 

CWMarketplace

December 2018: Top 10 Industry Provider Profiles

December 31, 2018

CWMarketPlace is a monthly section featuring a range of clinical research service providers who have Industry Provider Profile pages posted on CenterWatch.com. Included in their annual subscriptions, company profiles are randomly selected to appear in this section, providing added exposure for their products and services. To learn more about becoming an Industry Provider Profile page subscriber, contact Sales at (617) 948-5100.

Click on any provider to view the company’s complete online profile or search more profiles.

Features

Debarment Certification: A Must-Have in Any Clinical Trial Agreement

December 17, 2018

The debarment certification is one of the sections of central importance in a clinical trial agreement (CTA). This certification is a representation or warranty made by the institution, principal investigator, and, if applicable, affiliated hospitals or third-party facilities, that it is not debarred, disqualified or banned by the FDA from conducting clinical trials.

Pipeline

New Pipeline Updates from Genentech, Planmed Oy, and Gibson Oncology

December 17, 2018

Company Drug/Device Medical Condition Status
Bio-Thera Solutions BAT4306F CD-20-positive B-cell non-Hodgkins lymphoma Phase I trial initiated
Alligator Bioscience ATOR-1015 advanced solid tumor disease Phase I trial initiated enrolling up to 53 subjects at five clinics in Sweden and Denmark
Rodin Therapeutics RDN-929 snyaptopathies, a group of over 100 brain diseases characterized by synaptic loss and disfunction Phase I trial initiated
Protagonist Therapeutics, Inc. PN-10943 inflammatory bowel disease Phase I trial initiated
Aridis Pharmaceuticals AR-501 (gallium citrate) chronic bacterial lung infections in patients with Cystic Fibrosis Phase I/II trial initiated enrolling 96 (48 healthy and 48 with Cystic Fibrosis) subjects
Constellation Pharmaceuticals, Inc. CPI-1205 metsastic castration-resistant prostate cancer (mCRPC) Phase II trial initiated enrolling up to 35 subjects
KaNDy Therapeutics NT-814 troublesome post-menopausal symptoms, including hot flashes Phase II trial initiated enrolling up to 165 menopausal subjects aged 40 to 65 years
Levo Therapeutics, Inc. intranasal carbetocin (LV-101) Prader-Willi syndrome (PWS) Phase III trial initiated
Generex Biotechnology Corporation AE37 plus Keytruda (pembrolizumab) triple negative breast cancer IND clearance granted by the FDA
Virtus Pharmaceuticals, LLC generic Levorphanol Tartrate 2 mg tablets severe pain ANDA approval granted by the FDA
Asana Biosciences Janus Kinase (JAK) and Spleen Tyrosine Kinase (SYK) dual inhibitor ASN002 moderate-to-severe atopic dermatitis Fast Track Designation granted by the FDA
Gibson Oncology, LLC LMP-400 small molecule topoisomerase 1inhibitor Ewing sarcoma Rare Pediatric Disease Designation (RPDD) granted by the FDA
Sandoz, Inc. and Pear Therapeutics, Inc. reSET-O Opioid Use Disorder (OUD) Clearance granted by the FDA
Planmed Oy new features and intended uses of Planmed Verity orthopedic imaging solution reconstructive surgeries Approval granted by the FDA
Genentech Tecentriq and Avastin metastatic non-squamous non-small cell lung cancer (NSCLC) Approval granted by the FDA
Mayne Pharma Group Limited Tolsura (SUBA-itraconazole) systemic fungal infections Approval granted by the FDA