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Viramal seeks CROs for men’s and women’s health trials in 2016, global or US partner for TestoCream – exec
Viramal is open to contact from CROs and CMOs for a number of men’s and women’s health products with clinical trials initiating in 2016, said CEO Oliver Bates. The company is also searching for a global or US partner to commercialize its TestoCream product, with serious discussions anticipated in 2H16, Bates said.
The London, UK-based firm is seeking a full service CRO as soon as possible for a Phase III with its TestoCream product to initiate in 2H16, said Bates. It has shortlisted a few CROs for this trial, he said, but is open to contact from others. The company is also looking for both CROs and CMOs for several women’s health products for which Phase I/II studies are expected to initiate in 2Q16, Bates said. Approximately six studies in women’s health are expected to initiate between 2Q16 and 2017, subject to funding, he added.
CROs should have reproductive endocrinologists or OBGYN physicians on staff, depending on the product they’re working with, Bates said. CROs should also be able to work in conjunction with the firm’s in-house team, he noted.
The firm currently works with the Germany-based CMO NextPharma, as well as some additional European manufacturers for some of its products, but is open to contact from others, Bates said.
Viramal just enrolled two patients in a small PK study in the US using its latest formulation of TestoCream, and plans to initiate a pivotal Phase III in 2H16, which will enroll between 150 and 175 patients, Bates said.
TestoCream is a transdermal delivery of testosterone for male hormone therapy, developed on the company’s proprietary delivery platform, according to company information.
Viramal is looking for either a global or US commercial partner for TestoCream and will focus on regional territories thereafter, Bates said. The US market is the largest and thus the firm’s primary objective is to start there, before moving onto Europe, he said. The firm just initiated licensing conversations this year and discussions are in their early stages still, he said.
The ideal partner would be able to reach a broad patient market and not just the aging male to whom other similar products might apply, Bates said. The firm hopes to be in serious discussions with potential partners in 2H16, he added.
For its women’s products, the company is currently finalizing INDs for its drugs, which are known chemical entities delivered via the company’s platform technology, Bates explained. These products will be used to treat infertility in women with endometriosis and limit side effects of existing therapies, and provide estrogen therapy in multiple formulations for menopausal women, according to company information.
Viramal’s proprietary delivery platform is intended to improve safety, efficacy and patient acceptability, with both localized and systemic targeted delivery to optimize drug concentration, according to company information.
by Alissa Fleck in New York
This article appeared on BioPharm Insight