Welcome to your Update from the Clinic for the month of June. Neuralstem presented final data on a first-in-class drug for the treatment of major depressive disorder, which is proving to be an effective and non-invasive means to boost brain volume. OncoMed has a shaky start to its Phase I programs targeting the Wnt pathway in cancer stem cells, providing a hint of concern around the safety of these therapeutic candidates. Read on to find out more.
At the American Society of Clinical Psychopharmacology Annual Meeting in Hollywood, Florida, Neuralstem (CUR) reported final data from its Phase 1b study investigating a neurogenic small molecule compound for the treatment of major depressive disorder (MDD). Conventional theories underlying depression suggest that brain chemistry is the primary contributor to formation and onset. However, Neuralstem has bought into an emerging theory that brain physiology is equally important. NSI-189 was shown to induce proliferation of neurons in the hippocampal region of the brain in animal studies, increasing overall volume by as much as 20 per cent.
The small molecule is having positive results in humans. In a Phase 1b completed in Q413, patients (n=28) reported clinically meaningful reductions in both cognitive and depression symptoms following 28 consecutive daily administrations (find the study abstract here). Significant effects were observed across four scales commonly used to assess depression. Particularly large effect sizes were observed in the Symptoms of Depression Questionnaire (1.20 at eight weeks) and the Massachusetts General Cognitive and Physical Functioning Questionnaire (also 1.20 at eight weeks). The effect size, which is considered large above 0.80, measures the overall effect of a treatment on the patient.
OncoMed (OMED), a clinical-stage company targeting cancer stem cells with biologics, has voluntarily halted its Phase 1 programs investigating vantictumab, an antibody, and FZD8-Fc, a fusion protein, in multiple cancer indications due to mild-to-moderate bone adverse events. The biologics, which target the Wnt pathway, are being developed in partnership with Bayer and investigated alone and in combination with conventional chemotherapeutics for advanced solid tumours, HER2-negative breast cancer and advanced pancreatic cancer. The partial clinical hold will remain in effect until OncoMed submits additional data and protocol amendments requested by the FDA’s Division of Oncology Products.
StemCells (STEM) announced interim data from its Phase I/II investigating its HuCNS-SC stem cell platform in patients with dry age-related macular degeneration (AMD) at the recent ISSCR conference in Vancouver. Patients exhibited a 65 per cent reduction in geographic atrophy, which is characterized by degeneration of the retinal pigment epithelium found below the retina and subsequent vision impairment due to loss of rods and cones. Enrollment for the study was completed in February. These interim data are based on a minimum follow up of six months.
Now that it has approval to manufacture its placenta-expanded (PLX) cells, Pluristem (PSTI) continues to push forward with various therapeutic programs, including an orthopedic program, for which it just announced its latest target indication – rotator cuff injury. The U.S. FDA approved Pluristem’s manufacturing process in March.
That’s all for this past month. Hopefully OncoMed’s Wnt programs are back up and running shortly. Fortunately for the company, they have a safety net in diversification. Its pipeline currently has five therapeutic candidates. Investors clearly aren’t too concerned. The stock has been holding steady around the USD$22 mark, only off a little over 8 per cent from its July 7th open of USD$24.
Disclaimer: “Update from the Clinic” is a blog post generated by news flow from public regenerative medicine (RM) companies around the globe. As CCRM has public RM companies in its industry consortium, and the number of such companies is relatively limited on a global scale, Mark Curtis will sometimes include CCRM consortium members in his review. This blog post is provided for general information only and nothing contained in the material constitutes a recommendation for the purchase or sale of any security. The author is not a shareholder of any public RM company. To see a list of CCRM’s industry consortium members, please visit http://ccrm.ca/industry-consortium