The Development Path
Genevé Bio has planned a disciplined, rigorous development process.
Manufacturing
Genevé Bio has agreed to in-license a cell line that produces VEGF165 from ScinoPharm Biotech, a Taiwanese company. This cell line will be transferred to an experienced biocontract manufacturer in the United States. The selected manufacturer will further qualify the protein, manufacture a master cell bank, scale-up the production process, and produce the product required for clinical studies. Since manufacture of biotech products is sometimes difficult to transfer, our selection criteria emphasize both technical expertise in process development and the ability to manufacture a high quality product in commercial quantities.
Preclinical Development
Animal studies already carried out at the University of California, San Francisco (UCSF), Columbia University, Johns Hopkins Medical Center, and Duke in rats and rabbits strongly suggest that applying VEGF leads to repair and restoration of penile tissues including blood vessels, nerves and other cells important in erectile function.
For example, Dr Lue at UCSF concluded that "ligation of bilateral internal iliac arteries produced a reliable animal model of traumatic arteriogenic erectile dysfunction. Injection of VEGF165 into the penis minutes after arterial ligation facilitated the recovery of erectile function." The results are summarized in the graphic below:
Peak Sustained Intracavernous Pressure During Stimulation of the Cavernous Nerve
Source: Lee, Lue, et. al., The Effect of Vascular Endothelial Growth Factor on a Rat Model of Traumatic Arteriogenic Erectile Dysfunction, Journal of Urology, Vol 167; 761-767
Intracavernosal pressure (ICP) is a strong indicator of erectile function. The rats treated with 4 µgm of VEGF165 recovered to nearly the same level as the sham-operated (surgery w/o severing the arteries) rats.
In another study, Dr. Lue compared intracavernosal pressure in rats without diabetes and treated and untreated rats with diabetes:
Source: Shirai, Lue, et. al.; Vascular endothelial growth factor restores erectile function through modulation of the insulin-like growth factor system and sex hormone receptors in diabetic rat; Biochemical and Biophysical Research Communications 341 (2006) 755-762
The VEGF165-treated rats fared much better in all aspects.
The studies to date largely focused on demonstrating potential efficacy in animal models of different diseases. Our perspective is that time and money are saved by conducting careful studies to evaluate dosing, pharmacokinetics, and toxicology in animals on the finished product before rushing into the clinic. Therefore, we plan to undertake such studies in two or more species using VEGF165 produced using the cell line, processes and conditions we expect to use for commercial production.
Clinical Study
We will likely undertake a multi-pronged clinical program to demonstrate efficacy for different clinical indications.
Next, learn more about the Team