DocePLUS (docetaxel liposomal) / Plus Therap - LARVOL DELTA

Metabolic Engineering of Saccharomyces cerevisiae for Production of Canthaxanthin, Zeaxanthin, and Astaxanthin. (PubMed, J Fungi (Basel)) - "The engineered strain Sp_Bc-Can001 ∆gal80 was evaluated in a 5 L bioreactor fermentation, achieving a notable canthaxanthin titer of 60.36 ± 1.51 mg/L using sucrose. This research conclusively establishes S. cerevisiae as a viable platform for efficient carotenoid biosynthesis and, for the first time in this yeast system, illustrates sucrose's viability as a carbon source for canthaxanthin production. These findings pave the way for sustainable, cost-effective carotenoid production at an industrial scale."

Journal

Long-Term Outcomes with Ibrutinib Versus the Prior Regimen: A Pooled Analysis in Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL) with up to 7.5 Years of Extended Follow-up (ASH 2019) - P2, P3, P3b; "Methods Patients (pts) enrolled in SPARK (MCL2001; NCT01599949), RAY (MCL3001; NCT01646021), and PCYC-1104 (NCT01236391) received ibrutinib 560 mg orally once daily until progressive disease or unacceptable toxicity, and pts benefiting at end of study could enroll in the open-label long-term extension study CAN3001 (NCT01804686). In chemosensitive pts with late frontline POD, second-line ibrutinib PFS was 36% longer than frontline outcome. There was no notable emerging toxicity with additional follow-up."

Retrospective data • TP53

Phase 2 ready oncology drug receives FDA Orphan Drug Designation (GlobeNewswire) - "Cytori Therapeutics...announced that it received FDA orphan drug designation for its ATI-1123 chemotherapy drug product candidate, an albumin-stabilized pegylated liposomal docetaxel, for the treatment of small cell lung cancer."

Orphan drug • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer

"#Cytori Reports Summary of #FDA Feedback Regarding its #ATI1123 Product $CYTX https://t.co/ElRecnv4iA" (@1stOncology)

Cytori reports summary of FDA feedback regarding its ATI-1123 product (Cytori Press Release) - "Cytori Therapeutics...provided an update on the development of its proprietary drug, ATI-1123, based on recently obtained feedback from the United States Food and Drug Administration (FDA)....ATI-1123 has completed a phase I trial. Based on the FDA feedback, the Company plans to proceed with a follow-on phase II trial in platinum-sensitive small cell lung cancer who have progressed at least 60 days after initiation of first-line chemotherapy."

FDA event • New P2 trial

Cytori Reports Q1 2019 Business and Financial Results (GlobeNewswire, Cytori Therapeutics Inc.) - ATI-0918, a generic version of pegylated liposomal doxorubicin hydrochloride, is the lead product candidate. The Company plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) next year based on a successful bioequivalence study completed against the European reference drug...Cytori is also developing ATI-1123, a patented, albumin-stabilized pegylated liposomal docetaxel.

European regulatory