Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) has stated that the U.S FDA has accepted its license application for eflapegrastim after the company resubmitted it for filing. The regulator has set a goal for a Prescription Drug User Fee Act for September 9.
According to the CEO and President of Spectrum, Tom Riga, this step is crucial for the company as it tries to make it through the review process. Moreover, the company is working with the FDA to ensure the drug’s approval.
Spectrum Therapeutics is trying to identify where it can use eflapegrastim to reduce infection. The drug received the Biologics License Application after two phases III trials that tested its efficacy and safety in patients with breast cancer to manage neutropenia caused by myelosuppressive chemotherapy.
Alzamend Neuro Inc (NASDAQ: ALZN) has a contract with Atlasciences and iResearch
Alzamend Neuro Inc (NASDAQ: ALZN) announced its contract with iResearch Atlanta and Atlasciences Clinical Kansas to conduct and manage its Phase 2a dose-escalating study for patients with non-severe Alzheimer’s Disease. The company hopes to begin recruiting patients for the study in May.
The role of the study is to investigate the tolerability and safety of AL001 in steady-state, multiple-dose conditions. It will also help researchers determine the highest dose that patients with non-severe Alzheimer’s can tolerate. The company believe this AL001 could provide similar benefits to lithium while eliminating the adverse effects of the latter.
Alzamend’s CEO, Stephan Jackman, explained that the company partnered with Atlasciences for this Phase 1 study. For this reason, the company is glad to expand the partnership. Additionally, the company has added iResearch to the program as it has a highly skilled and experienced team.
AL001 could replace lithium
Jackman believes that AL001 could replace lithium as the standard of care by providing increased benefits and fewer adverse effects. It could also treat other neurological diseases other than Alzheimer’s disease.
In the phase 1 study, researchers administered lithium combined with AL001 three times each day to patients. Results indicated that the efficacy of the two drugs was almost similar. However, it could provide more benefits than lithium which could be lethal. Dosing lithium could be difficult because of the small gap between therapeutic and toxic doses.
