you have to wonder why they pulled the plug on the clinicals:
http://www.hairtoday.com/html/FNS.cfm
Osmotics set to launch new hair loss product formerly known as Piliel
Osmotics, a Denver-based cosmeceutical company, has taken over Piliel and is relaunching it in March of 2002. The product has been renamed FNS or Follicle Nutrient Serumâ„¢.
Piliel was originally developed by Professor Ella Lindenbaum of the Technion Faculty of Medicine in Haifa, Israel. Professor Lindenbaum and her team of researchers were searching for a way to heal stubborn wounds. While studying a head wound on a 14-year-old girl, Prof. Lindenbaum made dramatic discovery. After several previous unsuccessful attempts at healing the wound, Professor Lindenbaum tried an unconventional approach. She applied a nutrient rich jelly used to grow cells, tissues and organ cell cultures in laboratories. The jelly contained everything that cells need to grow - sugars, amino-acids, growth factors and all the nutrients that blood brings to the cells in a
body.
Within two weeks of applying the gel directly to the wound it finally healed. Then the doctors noticed something very unusual. Around the wound was a bald patch which, with this type of wound, you wouldn't expect to grow back, but where the gel was being applied the hair was growing back. It was then that Prof. Lindenbaum realized that she may have had discovered an effective treatment for stimulating hair growth.
This led to small-scale clinical studies in Israel and the results were very encouraging. Pilot trials on 15 patients (nine males, six females) in Israel showed 100% response. All of the patients, each of who have experienced hair loss for an average of 8.7 years, showed hair growth within four months of treatment: 13 out of 15 (87%) moderate hair growth and 2 out of 15 (13%) dense hair growth. All patients reported a cessation of hair loss within 1-3 weeks and new hair growth and increased growth rate of existing hair within one week to two months of treatment. Further use of Piliel beyond four months resulted in increased hair growth. No toxicity or side effects were observed throughout the study.
In an interview given by Professor Lindenbaum on October 2, 1995 she related the following observations about the trial:
"We have been involved in preliminary clinical trials on the Piliel and we have observed a number of changes that have taken place in the scalp of people who are suffering from Alopecia. The main change that we have been observing was the increased viability of the skin and that also involves all the skin of the nexia, that is to say the hair follicles, the sebaceous gland and the skin viability has increased by the increase in the circulating blood in the micro vessels in the skull. What we have seen is, first of all, cessation of hair loss in all of the patients that have been using the Piliel with a matter of two to three weeks. The second observation was an increase in the rate of hair growth, that is, existing hair grew much faster. And the third thing we saw is that hairs that have been in the process of dying or even follicles without hairs that are still there have started growing new hair.
So I'm not saying that we got new follicles, we did not get new follicles, but the follicles that are there were revitalized. Now this revitalization was observed both in the hair growth as well as in the diameter of the hair that grew and also in the coloration of the hair. What we have seen is that the stimulation is not only for synthesis of the proteins which make the hair shaft, but we saw also synthesis of the pigmentation of the hair which used to be during the earlier stage of the hair growth. That is, in patients where the hair is gray, the roots became darker and, therefore, we assume that there is melanogenesis, or pigment formation, with the hair follicle.
Also other characteristics of the hair have been returned. For example, the waviness of the hair has been observed as well. The scalp skin has improved in coloration and in texture. There is more vitality in the skin, there is less scaliness, less tendency for abrasions. So in a summary, one can say what we are getting is revitalization of the skin. Now, we have tried it on 15 patients and all the patients are extremely happy with the results, they don't want to stop with the treatment, and we are now going on some patients already for 7 to 8 months of treatment with very good results. The results are between moderate to dense growth."
In order to bring a new drug like Piliel to market millions of dollars are needed to conduct the necessary tests required by the FDA for the drugs approval. So Professor Lindenbaum partnered with Life Medical Sciences, Inc., a Princeton, New Jersey-based company established in August, 1990 by Dr. Herbert Moskowitz, a co-founder, and previous Chairman, President and CEO of Advanced Tissue Sciences.
The Company commenced an initial public offering in September 1992, raising $6 million, followed by an $8 million secondary offering ten months later. Life Medical Sciences then began conducting pivotal trials of Piliel at multiple sites in Europe for the stimulation of hair regrowth and for the reduction of hair loss. The pivotal study, designed for market approval in certain European countries, was a randomized, double blind and placebo-controlled study and tested Piliel in it's lyophilized (freeze dried) formulation. The study was designed to measure the effectiveness of Piliel for the most common form of hair loss, Androgenetic Alopecia, in both men and women. The eight-month study consisted of once daily treatment applications followed by a three-month follow up period without treatment application.
The study, which began in The Netherlands and Belgium in November 1996, had approximately 140 subjects and the results were expected to be out by the end of 1998. The anticipated date of Piliel's availability was supposed to be sometime in 1999. Then Life Medical Sciences announced in December 1997 that it was terminating its clinical trial citing that the product was not likely to generate satisfactory results for male pattern baldness. Many people were surprised by this announcement since much hope had been placed in this product, and one of the participants in the original trial in Israel publicly expressed his shock because he had received excellent results himself.
What happened afterwards was the subject of much speculation and the product gradually faded from the scene. However it is now known that in March 2002 it will reemerge under the Osmotics banner as a product called F.N.S or Follicle Nutrient Serum(tm). Osmotics have bought the exclusive license to sell the product from the developer Professor Lindenbaum. It will be Osmotics' first hair care treatment. Osmotics already has a range of skin care products based on the Copper Peptide technology licensed from ProCyte, the makers of Tricomin.
Within two weeks of applying the gel directly to the wound it finally healed. Then the doctors noticed something very unusual. Around the wound was a bald patch which, with this type of wound, you wouldn't expect to grow back, but where the gel was being applied the hair was growing back. It was then that Prof. Lindenbaum realized that she may have had discovered an effective treatment for stimulating hair growth.
The Follicle Nutrient Serumâ„¢ is believed to work by supplying the follicles with nutritional and growth factors bypassing the limitations of the circulatory system. It essentially provides the follicles with nutrition directly using an advanced delivery system.
The product will be available as a 4fl oz spray which will retail for $60. The company recommends applying it once daily at night before bedtime. The product should be applied to a hydrated, moist scalp and massaged in. It would then be rinsed out the next morning.
Hairlosshelp will be conducting an interview with the company about their new product shortly.
http://www.hairtoday.com/html/FNS.cfm
Osmotics set to launch new hair loss product formerly known as Piliel
Osmotics, a Denver-based cosmeceutical company, has taken over Piliel and is relaunching it in March of 2002. The product has been renamed FNS or Follicle Nutrient Serumâ„¢.
Piliel was originally developed by Professor Ella Lindenbaum of the Technion Faculty of Medicine in Haifa, Israel. Professor Lindenbaum and her team of researchers were searching for a way to heal stubborn wounds. While studying a head wound on a 14-year-old girl, Prof. Lindenbaum made dramatic discovery. After several previous unsuccessful attempts at healing the wound, Professor Lindenbaum tried an unconventional approach. She applied a nutrient rich jelly used to grow cells, tissues and organ cell cultures in laboratories. The jelly contained everything that cells need to grow - sugars, amino-acids, growth factors and all the nutrients that blood brings to the cells in a
body.
Within two weeks of applying the gel directly to the wound it finally healed. Then the doctors noticed something very unusual. Around the wound was a bald patch which, with this type of wound, you wouldn't expect to grow back, but where the gel was being applied the hair was growing back. It was then that Prof. Lindenbaum realized that she may have had discovered an effective treatment for stimulating hair growth.
This led to small-scale clinical studies in Israel and the results were very encouraging. Pilot trials on 15 patients (nine males, six females) in Israel showed 100% response. All of the patients, each of who have experienced hair loss for an average of 8.7 years, showed hair growth within four months of treatment: 13 out of 15 (87%) moderate hair growth and 2 out of 15 (13%) dense hair growth. All patients reported a cessation of hair loss within 1-3 weeks and new hair growth and increased growth rate of existing hair within one week to two months of treatment. Further use of Piliel beyond four months resulted in increased hair growth. No toxicity or side effects were observed throughout the study.
In an interview given by Professor Lindenbaum on October 2, 1995 she related the following observations about the trial:
"We have been involved in preliminary clinical trials on the Piliel and we have observed a number of changes that have taken place in the scalp of people who are suffering from Alopecia. The main change that we have been observing was the increased viability of the skin and that also involves all the skin of the nexia, that is to say the hair follicles, the sebaceous gland and the skin viability has increased by the increase in the circulating blood in the micro vessels in the skull. What we have seen is, first of all, cessation of hair loss in all of the patients that have been using the Piliel with a matter of two to three weeks. The second observation was an increase in the rate of hair growth, that is, existing hair grew much faster. And the third thing we saw is that hairs that have been in the process of dying or even follicles without hairs that are still there have started growing new hair.
So I'm not saying that we got new follicles, we did not get new follicles, but the follicles that are there were revitalized. Now this revitalization was observed both in the hair growth as well as in the diameter of the hair that grew and also in the coloration of the hair. What we have seen is that the stimulation is not only for synthesis of the proteins which make the hair shaft, but we saw also synthesis of the pigmentation of the hair which used to be during the earlier stage of the hair growth. That is, in patients where the hair is gray, the roots became darker and, therefore, we assume that there is melanogenesis, or pigment formation, with the hair follicle.
Also other characteristics of the hair have been returned. For example, the waviness of the hair has been observed as well. The scalp skin has improved in coloration and in texture. There is more vitality in the skin, there is less scaliness, less tendency for abrasions. So in a summary, one can say what we are getting is revitalization of the skin. Now, we have tried it on 15 patients and all the patients are extremely happy with the results, they don't want to stop with the treatment, and we are now going on some patients already for 7 to 8 months of treatment with very good results. The results are between moderate to dense growth."
In order to bring a new drug like Piliel to market millions of dollars are needed to conduct the necessary tests required by the FDA for the drugs approval. So Professor Lindenbaum partnered with Life Medical Sciences, Inc., a Princeton, New Jersey-based company established in August, 1990 by Dr. Herbert Moskowitz, a co-founder, and previous Chairman, President and CEO of Advanced Tissue Sciences.
The Company commenced an initial public offering in September 1992, raising $6 million, followed by an $8 million secondary offering ten months later. Life Medical Sciences then began conducting pivotal trials of Piliel at multiple sites in Europe for the stimulation of hair regrowth and for the reduction of hair loss. The pivotal study, designed for market approval in certain European countries, was a randomized, double blind and placebo-controlled study and tested Piliel in it's lyophilized (freeze dried) formulation. The study was designed to measure the effectiveness of Piliel for the most common form of hair loss, Androgenetic Alopecia, in both men and women. The eight-month study consisted of once daily treatment applications followed by a three-month follow up period without treatment application.
The study, which began in The Netherlands and Belgium in November 1996, had approximately 140 subjects and the results were expected to be out by the end of 1998. The anticipated date of Piliel's availability was supposed to be sometime in 1999. Then Life Medical Sciences announced in December 1997 that it was terminating its clinical trial citing that the product was not likely to generate satisfactory results for male pattern baldness. Many people were surprised by this announcement since much hope had been placed in this product, and one of the participants in the original trial in Israel publicly expressed his shock because he had received excellent results himself.
What happened afterwards was the subject of much speculation and the product gradually faded from the scene. However it is now known that in March 2002 it will reemerge under the Osmotics banner as a product called F.N.S or Follicle Nutrient Serum(tm). Osmotics have bought the exclusive license to sell the product from the developer Professor Lindenbaum. It will be Osmotics' first hair care treatment. Osmotics already has a range of skin care products based on the Copper Peptide technology licensed from ProCyte, the makers of Tricomin.
Within two weeks of applying the gel directly to the wound it finally healed. Then the doctors noticed something very unusual. Around the wound was a bald patch which, with this type of wound, you wouldn't expect to grow back, but where the gel was being applied the hair was growing back. It was then that Prof. Lindenbaum realized that she may have had discovered an effective treatment for stimulating hair growth.
The Follicle Nutrient Serumâ„¢ is believed to work by supplying the follicles with nutritional and growth factors bypassing the limitations of the circulatory system. It essentially provides the follicles with nutrition directly using an advanced delivery system.
The product will be available as a 4fl oz spray which will retail for $60. The company recommends applying it once daily at night before bedtime. The product should be applied to a hydrated, moist scalp and massaged in. It would then be rinsed out the next morning.
Hairlosshelp will be conducting an interview with the company about their new product shortly.
