- |||||||||| Ovastat (treosulfan) / Medac
Clinical, Journal: Pre-formulation investigations for establishing a protocol for treosulfan handling and activation. (Pubmed Central) - Aug 15, 2019 The stability profiling of treosulfan provided a valuable reference for handling of biological samples for both in vivo and in vitro studies. These results can be utilized for further investigations concerning the drug kinetics and dynamics in addition to the development of new pharmaceutical formulations.
- |||||||||| Herceptin (trastuzumab) / Roche, Ultomiris IV (ravulizumab IV) / Alexion Pharma
Journal: Antibodies to watch in 2019. (Pubmed Central) - Aug 1, 2019 In addition, our data show that 3 product candidates (leronlimab, brolucizumab, polatuzumab vedotin) may enter regulatory review by the end of 2018, and at least 12 (eptinezumab, teprotumumab, crizanlizumab, satralizumab, tanezumab, isatuximab, spartalizumab, MOR208, oportuzumab monatox, TSR-042, enfortumab vedotin, ublituximab) may enter regulatory review in 2019...Of these, 7 (tremelimumab, spartalizumab, BCD-100, omburtamab, mirvetuximab soravtansine, trastuzumab duocarmazine, and depatuxizumab mafodotin) are being evaluated in clinical studies with primary completion dates in late 2018 and in 2019, and are thus 'antibodies to watch'. We look forward to documenting progress made with these and other 'antibodies to watch' in the next installment of this article series.
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Trial completion date, Trial primary completion date: Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters (clinicaltrials.gov) - Jul 22, 2019 P4, N=40, Recruiting, We look forward to documenting progress made with these and other 'antibodies to watch' in the next installment of this article series. Trial completion date: Apr 2020 --> Apr 2021 | Trial primary completion date: Dec 2019 --> Dec 2020
- |||||||||| Natesto (testosterone) / Acerus, Aytu BioScience, Medac
Journal: Proteins and RNA sequences required for the transition of the t-Utp complex into the SSU processome. (Pubmed Central) - Jul 13, 2019 ...Pol5, accessory factor, dissociated as t-Utps matured into the UtpA complex which permitted later recruitment of the UtpB, U3 snoRNP and the Mpp10 complex into the SSU processome...However, ectopic expression of the short transcripts slowed the growth of yeast with impaired rDNA transcription. These results provide insight into how transcription of the rRNA primes the assemble of t-Utp complex with the pre-rRNA into the UtpA complex and the later association of SSU processome components.
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Trial completion date, Trial primary completion date: Evaluation of Testosterone Nasal Gel in Hypogonadal Boys (clinicaltrials.gov) - Jul 5, 2019 P1, N=20, Recruiting, Recruiting --> Active, not recruiting Trial completion date: May 2019 --> Nov 2020 | Trial primary completion date: May 2019 --> Nov 2020
- |||||||||| Review, Journal: HER2 Directed Antibody-Drug-Conjugates beyond T-DM1 in Breast Cancer. (Pubmed Central) - Jun 15, 2019
Currently, several HER2 directed antibody-drug conjugates are under clinical investigation for HER2 amplified but also HER2 expressing but not amplified breast tumors. In this article, we review the current preclinical and clinical evidence of the investigational drugs A166, ALT-P7, ARX788, DHES0815A, DS-8201a, RC48, SYD985, MEDI4276 and XMT-1522.
- |||||||||| Leunase (L-asparaginase) / Kyowa Kirin, Kidrolase (L-asparaginase) / Jazz, Merck (MSD), Spectrila (asparaginase Escherichia coli) / Medac
Trial completion: AALL07P2: Erwinia Asparaginase After Allergy to PEG-Asparaginase in Treating Young Patients With Acute Lymphoblastic Leukemia (clinicaltrials.gov) - Jun 6, 2019 P=N/A, N=59, Completed, In this article, we review the current preclinical and clinical evidence of the investigational drugs A166, ALT-P7, ARX788, DHES0815A, DS-8201a, RC48, SYD985, MEDI4276 and XMT-1522. Active, not recruiting --> Completed
- |||||||||| Natesto (testosterone) / Acerus, Aytu BioScience, Medac
Clinical, P4 data, Journal: Natesto Effects on Reproductive Hormones and Semen Parameters: Results from an Ongoing Single-center, Investigator-initiated Phase IV Clinical Trial. (Pubmed Central) - Apr 3, 2019 Since in HLH patients HLA-haploidentical HSCT performed through CD34+ cell positive selection was found to be associated with poor sustained engraftment of donor cells, innovative approaches able to guarantee a more robust engraftment are warranted in patients given this type of allograft. Promising initial data from our perspective clinical trial demonstrates that Natesto can not only increase serum testosterone but also maintain follicle-stimulating hormone, luteinizing hormone, and importantly, semen parameters.
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