Texas is quickly becoming a hotbed of biopharmaceutical activities, with Houston being one of the two top cities in the state that is leading the way.
Texas is quickly becoming a hotbed of biopharmaceutical activities, with Houston being one of the two top cities in the state that is leading the way. A good case in point includes Hope Biosciences Stem Cell Research Foundation (HBSCRF), a Houston-area non-profit that recently received the go-ahead from the U.S. Food and Drug Administration (FDA) to initiate a double-blind, placebo-controlled Phase II study on intravenous infusions of autologous adipose-derived mesenchymal stem cells in Parkinson’s disease.
With the new approval, the trial from HBSCRF represents the first global study to use pure adipose-derived mesenchymal stem cells delivered at high quantities over repeat treatments in patients with Parkinson’s disease. A total of 24 patients with the neurodegenerative disorder will be randomly assigned to six intravenous infusions comprising 200 million stem cells each.
The FDA approval is the company’s third FDA-authorized study for Parkinson’s disease to date, said HBSCRF Founder Donna Chang, in a statement. “The first two were FDA-authorized expanded access, single-patient studies. From those, we gained an idea of what doses and periodicity of stem cell yielded dramatic results, and so were able to design this larger clinical trial very deliberately,” she said. “This is exactly how clinical research works at its best – every patient provides greater understanding. We are hopeful this larger trial will confirm what we see in the expanded access studies and help get treatment to more people and families.”
So far, the company’s first patient with Parkinson’s disease has been treated with over 20 infusions. According to a primary investigating physician of the study, this patient has reportedly experienced a “remarkable improvement” in their activities of daily living.
Additionally, this patient does not require a 24-hour caretaker, compared with before the study, and the treating neurologist has stated that the patient shows no measurable sign of disease. This week, HBSCRF’s second patient with Parkinson’s disease will receive their third dose of the investigational stem cells treatment approach.
“Stem cells are the hope for degenerative conditions, but success is only possible with continued administration of healthy, fresh, viable cells,” explained Chang. “We have finally overcome the major hurdles of cell therapy. Now we must figure out how many doses it takes to deliver consistent results. We are just scratching the surface of potential for these cells.”
Aside from Parkinson’s disease, the FDA has also authorized 17 clinical trials from HBSCRF across ten diseased areas. To date, the company has administered approximately 100 billion cells to patients over one year.
Another Houston area company, ESSA Pharmaceuticals, Inc., also shows promise among the top leading biopharmaceutical companies in the country. Today, ESSA announced it had entered a clinical collaboration agreement with Bayer to examine a combination therapy involving an ESSA’s first-in-class N-terminal domain androgen receptor inhibitor EPI-7386 with Bayer’s androgen receptor inhibitor darolutamide in patients with metastatic castration-resistant prostate cancer (mCRPC).
The terms of the agreement give Bayer the option of sponsoring and conducting a Phase I/II clinical trial to assess the safety, pharmacokinetics, and efficacy of the dual treatment in patients with mCRPC. In turn, ESSA has agreed to supply Bayer with EPI-7386 for the study and will retain the rights to its investigational candidate.
In the announcement of the collaboration agreement, the two companies stated that the first clinical trial should launch sometime this year.
“We are delighted to collaborate with Bayer to explore the potential clinical role of EPI-7386 in combination with Bayer’s darolutamide in patients with metastatic castration-resistant prostate cancer, who have progressed on androgen deprivation therapy,” according to a statement made by ESSA’s Chief Executive Officer Dr. David R. Parkinson. “Combining our two therapies will simultaneously target both ends of the androgen receptor, and potentially allow for a more potent approach to suppressing androgen activity. We look forward to investigating the combination of these therapies and their potential role together in the treatment of prostate cancer.”
