Generex Provides Positive Update on Generex Oral-lyn Pivotal Phase III Trial

Study has now achieved 75% of the required number of per-protocol completers

30-Jul-2010 - Generex Biotechnology Corporation announced that it has now achieved 75% of the required number of per-protocol completers in its ongoing six month pivotal global Phase III study of Generex Oral-lyn™, the Company’s proprietary buccal insulin spray product. These early results suggest that, ...

Generex Biotechnology Reports Preliminary Outcomes and Trends from Ongoing Phase III Clinical Trial of Generex Oral-lyn

Findings based on in-process data for subjects that completed the 6-month treatment phase of the study demonstrate several favorable comparisons to injectable insulin

08-Jun-2010 - Generex Biotechnology Corporation reported preliminary outcomes and trends from the ongoing Phase III pivotal study of Generex Oral-lyn™, the Company’s proprietary oral insulin spray product. Observations were made regarding insulin antibody levels, weight gain, body mass index, and ...

Generex Biotechnology Achieves Enrollment of Over 400 Subjects in Phase III Generex Oral-lyn Study

11-May-2010 - Generex Biotechnology Corporation announced that it has achieved enrollment of over 400 subjects in its pivotal global Phase III study of its flagship product, Generex Oral-lyn™, a proprietary buccal insulin spray product designed to replace prandial injections of insulin. Generex will continue ...

Generex Receives New US Patent for its Proprietary Buccal Drug Delivery Platform Technologies

Patent covers Method for Administration of Insulin to the Buccal Region

03-May-2010 - Generex Biotechnology Corporation announced that it has received a new patent in the United States. The Director of the United States Patent and Trademark Office has granted the Company a patent titled, “Method for Administering Insulin to the Buccal Region”. This new patent increases the ...

Generex announces USFDA approval of use of company's buccal insulin product

14-Sep-2009 - Generex Biotechnology Corporation announced that the U.S. Food and Drug Administration (FDA) has granted approval for the treatment use of Generex Oral-lyn™ under the FDA’s Treatment Investigational New Drug (IND) program. Under a structured Treatment IND protocol, Generex Oral-lyn ™ will be ...

Generex Announces Enrollment of Over 150 Patients In Phase III Trial of Generex Oral-lyn

More than 100 patients currently receiving Generex Oral-lyn; Some Patients for more than Three Months

15-Aug-2008 - Generex Biotechnology Corporation announced that it has initiated enrolled over 150 patients in the Company's pivotal Phase III clinical trial of Generex Oral-lyn(TM), its flagship proprietary oral insulin spray product. Of those patients, over 100 have been dosed. There are 55 sites in the ...

Generex Biotechnology announces North American initiation of Generex Oral-lynT Phase III Diabetes Study

09-Apr-2008 - Generex Biotechnology Corporation announced that it has initiated the Phase III protocol in North America for its proprietary buccally-absorbed oral insulin spray product, Generex Oral-lyn, with the commencement of patient screening. The first screening took place in late March in Texas. Other ...

Generex Biotechnology receives regulatory approval to initiate Phase III clinical trial for Generex Oral-lyn

Ministry of Health of the Ukraine approves Phase III protocol GEN084-OL for a number of clinical sites in the Ukraine

25-Jan-2008 - Generex Biotechnology Corporation announced that on January 22, 2008 the Ministry of Health of the Ukraine issued an approval letter for the conduct of a Phase III clinical trial protocol for Generex Oral-lyn at eight clinical sites located in the Ukraine. The significance of this approval is ...

Generex Biotechnology receives approval from the Ministry of Health of the United Arab Emirates to sell Generex Oral-lyn T

Imperial College London Diabetes Centre receives approval to sell to patients through the diabetes centre in Abu Dhabi, United Arab Emirates

13-Dec-2007 - Generex Biotechnology Corporation announced that the Ministry of Health of the United Arab Emirates, Drugs Control Department has issued a non-objection letter to the Imperial College London Diabetes Centre to import Generex Oral-lyn, Generex's proprietary oral insulin spray product, into Abu ...

First Metformin gum patent granted to Generex Biotechnology

16-Nov-2006 - Generex Biotechnology Corporation announced that it has been granted the first patent for its medicinal gum platform titled "Compositions for Oral Transmucosal Delivery of Metformin". The patent covers claims to the composition, processes, and methodologies for the delivery of an oral ...