Oral-lyn's FDA Approval
GNBT's Oral-lyn, an oral insulin medicinal spray, was granted approval last week under the FDA's Expanded Access Treatment Investigational New Drug (IND) program. This means that, by showing benefits that outweigh the risks associated with patients for whom currently approved drugs are no longer effective, Oral-lyn can now be prescribed as an alternative therapeutic option. GNBT is now planning to further broaden Oral-lyn's access to patients in North America, where the company expects to introduce a new paradigm for the treatment of diabetes based on it's proprietary oral insulin product. The FDA's permission for Oral-lyn's prescription by physicians is viewed as a considerable attraction for partnerships and collaborations as GNBT penetrates the North American market with this novel drug. For additional details, see GNBT's press release.
Peptide Vaccine Receives Patent in China
The peptide vaccine technology, Ii-Key, developed by GNBT's subsidiary, Antigen Express Inc., obtained a patent in China last week, enabling GNBT to initiate conversations with a number of big pharmas regarding potential joint venture/licensing partnership. The Toronto-based biotech is backed by positive interim results (13-month time point) from a Phase II trial of an Ii-Key modified peptide vaccine for patients treated for breast cancer who are at high risk of relapse. The study reported a 7% relapse rate in the control arm versus 0% relapses in the Ii-Key peptide arm (AE37). GNBT's CEO, Anna Gluskin, stated that she is "confident that with the right partnerships, [the Ii Key modified peptide vaccine] technology can have a far reaching positive impact on the treatment of many types of cancers and [GNBT] intends to aggressively pursue its goal of bringing these platform technologies to the commercialization stage." For additional details, see GNBT's press release.
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