More information has been disclosed regarding a new natural treatment for hair loss that is being clinically studied for hair loss. The product is from an extract from a single plant species and is called P45. It is currently in Phase II clinical testing.
The following information is from Phytopharm’s website regarding P45:
Based on anecdotes of the successful treatment of alopecia totalis and areata spanning the last six years, Phytopharm is currently developing P45, a topical preparation for the treatment of alopecia. The developed formulation contains an extract from a single plant in an aqueous cream base.
Phytopharm intends to develop P45 as a treatment for male pattern baldness, alopecia areata, alopecia totalis and universalis.
Non-clinical data supports the safety of P45 cream for topical use in the treatment of alopecia. P45 cream consists of a complex mixture and it is not yet clear which of the constituents are important to the therapeutic effect seen. These studies will be carried out once the initial pharmacological and clinical studies have been completed.
Clinical Program
Anecdotal and photographic evidence is available which shows an effect when the extract has been applied topically to various alopecia types. In addition there is an independent evaluation by an endocrinologist specializing in trichology looking at the effects on this extract in alopecia.
Following the granting of a CTX in the UK, Phytopharm has commenced a multi-center Phase II clinical evaluation of P45 in androgenic alopecia. 70 patients will be treated with either P45 or placebo for 12 months. Following a 6 month review the safety profile has warranted the continuation of the trial. The full results are expected to report in Q4 2000.
Patents
European and US patents have been granted. The patents refer to a composition and use of the extract to stimulate hair growth and prevent hair loss.
Regarding their phase II trials:
Phytopharm plc (PYM: London Stock Exchange) (“Phytopharm”) announced today that it has conducted an interim review of its phase II clinical trial of P45, its patented topical cream for the treatment of androgenetic alopecia (male pattern baldness).
In this study, patients are being treated with either P45 or an inert placebo for 52 weeks. Using a double blind trial design, 69 patients have been randomly assigned to receive either P45 or placebo cream. Neither the patients, the investigating physicians nor Phytopharm are aware of which subjects are using the active material.
The purpose of the review was to examine the safety and conduct of the study using blinded data collected from all patients after 20 weeks of treatment. With regard to the conduct of the study, recruitment has been satisfactory and is now complete. The safety data have revealed no treatment-related serious adverse events, and the emergent safety profile warrants the continuation of the study. All patients are due to complete treatment during Q3 2000. An analysis of the full data set is expected to be available in Q4 2000.
Data have been collected on the investigators’ and patients’ assessments of hair growth and scalp condition. Photographic records have also been generated. There are apparent differences between the groups according to the various safety and efficacy parameters. However, these data collected at the midpoint of the study are preliminary and blinded with respect to the treatment and placebo groups.
Dr. Richard Dixey, Chief Executive of Phytopharm, said:
“this study is proceeding satisfactorily but we cannot unblind the data without invalidating the final result. We must await the full analysis of the unblinded data at the end of the 52 week treatment period before any conclusions can be drawn”.
Most recent announcement from November 16:
Phytopharm plc (PYM: London Stock Exchange) (“Phytopharm”) announces today that it has commenced a Phase II clinical study to investigate the safety and efficacy of its patented topical treatment, P45, for severe forms of alopecia, including alopecia areata and totalis. Phytopharm is already undertaking a Phase II trial investigating the safety and efficacy of P45 in alopecia androgenica (male pattern baldness), the results of which are expected to be available in Q1 2001.
The study will be an open label, single center study of up to 30 subjects with at least 50% scalp hair loss due to alopecia areata. The P45 cream will be applied to the scalp twice daily for a period of 26 weeks. Both the investigator and the patients will assess the extent of hair re-growth in response to treatment. In addition, serial photographs will be taken for evaluation at the end of the study.
Alopecia areata is a distressing condition that can affect individuals of all ages. It is characterized by the sudden appearance of circular areas of total hair loss, which can ultimately affect the entire scalp (termed alopecia totalis). The underlying cause is unknown, although there is circumstantial evidence to suggest that it is an auto-immune disorder. Although spontaneous remission can occur in mild forms, severe forms often progress to alopecia totalis and are unresponsive to current therapies.
Dr. Richard Dixey, Chief Executive of Phytopharm, said:
”The study announced today further extends our research program into hair loss with our product P45. The interim review of our ongoing study in alopecia androgenica conducted in January of this year revealed a good safety profile for the product, and has cleared the way for the commencement of this second study into the auto-immune form of the disease.”
