Hair Regeneration Therapy

ICX-TRC is an autologous hair regeneration therapy intended for the treatment of male pattern baldness and female diffuse alopecia.

A small biopsy or sample of hair follicles will be taken from the patient during a simple 30 minute operation carried out under local anaesthetic at a hair or skin clinic.

The clinic would send the biopsy to Intercytex’ manufacturing facility where the hair-inductive dermal papilla cells would be “dissociated” from the rest of the follicle.

These cells would be cultured and expanded in proprietary media over the next three weeks and subsequently returned to the clinic in a sterile suspension.

Using a specialised delivery system, the hair-inductive dermal papilla cells would be microinjected intradermally into the patient’s scalp.

The treatment will be performed under local anaesthetic and will comprise a single procedure of superficial injections, each injection delivering a minute volume of media containing dermal papilla cells capable of inducing new hair growth.

Following the procedure, new hair growth should become evident after approximately three months.

ICX-TRC will be used by specialists in hair transplant centres, dermatologists and plastic surgeons to treat patients with hair thinning or hair loss.

Intercytex will initially develop ICX-TRC to treat male pattern baldness and expand it to treat female diffuse alopecia.

Phase I clinical trials (safety) have been completed in seven volunteers at a single UK transplant centre.

No safety issues have arisen and five out of the seven patients have shown increased hair numbers.

A high dose trial will commence in the UK during the first half of 2005, this will be followed by a multi-centre Phase II clinical trial on patients with male pattern baldness.

The Phase II trial is planned for the first half of 2006 and will be performed in both the UK and US.

A Phase III trial for both male pattern baldness and female diffuse alopecia is planned for 2007.