'Oryzon continued to make strong clinical progress in the fourth quarter,' said Dr.
Fourth Quarter and Recent Highlights
Iadademstat in oncology: New positive efficacy data from Phase II trial ALICE, investigating iadademstat in acute myeloid leukemia (AML) at the 61st ASH Annual Meeting and Exposition in
Reported objective responses in 6 out of 8 evaluable patients (75% OR): of these, there were 2 complete remissions (CR), 3 complete remissions with incomplete hematologic recovery (CRi) and 1 partial remission (PR).
The mean follow-up time amongst the evaluable patients was 20 weeks, with a mean Time to Response (TTR) of only 32 days in those patients who responded.
Two of the 5 patients (40%) that had received more than 3 cycles of treatment had also become transfusion independent.
Encouraging preliminary efficacy data from the first 8 patients in the CLEPSIDRA Phase II trial evaluating the safety and clinical efficacy of iadademstat in combination with platinum/etoposide in second-line small cell lung cancer (SCLC) patients at the ESMO conference in
Reported responses in 6 out of 8 patients (75% response rate), with 4 partial remissions and 2 long-term disease stabilizations in patients treated with iadademstat plus carboplatin/etoposide.
Demonstrated durable treatment response with one partial remission patient at cycle 13 and still in response. This patient showed an initial 78.7% tumor reduction as determined by RECIST after 6 cycles of iadademstat plus carboplatin/etoposide. Tumor reduction continued upon iadademstat monotherapy after the combo cycles, with 86.3% of tumor reduction by RECIST at the end of cycle 12.
The clinical trial continues to recruit patients and investigate dosing regimens to minimize hematological toxicity of the combination.
Vafidemstat in neurological disease: Additional positive Phase IIa REIMAGINE efficacy data of vafidemstat in the treatment of aggression in three psychiatric diseases at the 2019
Reported data from ADHD, BDP and ASD and aggregated cohorts demonstrating statistically significant improvements in several scales measuring aggression such as the Clinical Global Impression (CGI) of Severity (CGI-S) and Improvement (CGI-I) scales and the Neuropsychiatric Inventory (NPI) 4-item Agitation/Aggression subscale.
Benefits also observed on several scales more generally assessing the global condition of the patients, such as the Neuropsychiatric Inventory (NPI) total score, the global BPD checklist (BPDCL) scale (for BPD patients) and the ADHD Rating Scale (ADHD-RS) (for ADHD patients).
On the strength of these data, the company is currently preparing a Phase IIb trial in BPD (PORTICO trial), expected to start in 1H2020, and is evaluating additional Phase IIb studies in ADHD and/or ASD.
The company has completed the recruitment in REIMAGINE-AD, a Phase IIa trial evaluating the effect of vafidemstat to treat aggressiveness in moderate and severe Alzheimer's disease (AD) with a total of 12 patients. The company plans to report the results of this study at the AAT-AD/PD conference in
The company has completed recruitment of the Phase IIa ETHERAL trial in
The company announced that the extension phase of the SATEEN Phase IIa clinical trial evaluating vafidemstat in multiple sclerosis has been extended in patients with the secondary progressive form of the disease up to a maximum of 18 months of vafidemstat treatment. This extension will allow the assessment of the effect of vafidemstat as a therapeutic treatment for the progressive form of the disease which requires longer clinical observation periods.
Financial Update: Fourth Quarter 2019 Financial Results
Research and development (R&D) expenses were
General and administrative expenses were
Net losses were
Negative net result of
Cash, cash equivalents and marketable securities totaled
About Oryzon
Founded in 2000 in
FORWARD-LOOKING STATEMENTS
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