FANTASTIC NEWS !!!!!!!!!!!!!!!!!!!!!!!!!!!!


04 Jan 07
Neosil Announces Positive Phase 2 Data for NEOSH101, an Investigational Treatment for Androgenetic Alopecia

EMERYVILLE, CA -- (MARKET WIRE) -- January 04, 2007 -- Neosil, Inc., a privately held dermatology-focused pharmaceutical company, today announced positive Phase 2a clinical data demonstrating that its lead product, NEOSH101, increased hair growth significantly in men diagnosed with androgenetic alopecia, also known as pattern hair loss (PHL). Androgenetic alopecia or PHL, caused by a combination of genetic and hormonal factors, is noticeable in about 20 percent of the population by age 20 and increases steadily with age. By age 50 approximately half of the U.S. population will have some degree of PHL.*

"Based on the results of this study, we are quite encouraged by the increase in hair growth observed after such a short once-daily treatment regimen with NEOSH101," said Vera H. Price, MD, FRCP(C), Professor of Clinical Dermatology, Department of Dermatology, University of California, San Francisco.

In a randomized, double-blind Phase 2a clinical study, conducted in Germany, 50 men with androgenetic alopecia (Norwood/Hamilton grades III-IV) received once-daily topical treatments of NEOSH101 or placebo over two 14-day treatment periods, which were separated by a one-month drug-free interval. Hair growth was measured using an objective photographic, computer-based analysis for up to 24 weeks after initiation of therapy. Results show that NEOSH101 was safe and well tolerated. A statistically significant increase in total hair count (4.8%, p=0.04), and cumulative hair thickness (3.7%, p=0.02) were observed, with peak effects occurring eight weeks following the second treatment cycle.

"The results of this study are encouraging, particularly the finding of increased numbers of terminal hairs, those hairs that are thicker than 40 microns and desirable for scalp coverage," said Andria Langenberg, M.D., Vice President of Clinical Development at Neosil. "We plan to initiate a Phase 2b study to evaluate daily treatment with NEOSH101 for a longer treatment period in men with PHL."

About Neosil

Neosil, Inc. is a privately held dermatology-focused pharmaceutical company that was funded in November 2004 with a $32 million investment by MPM Capital and Burrill & Company, following initial incubation funding by Shalon Ventures, LP. In addition to its topical hair growth product, NEOSH101, Neosil is developing a broad-spectrum topical anti-microbial agent for acne and anti-infective use.

* Nyholt, D.R., et al.: Genetic basis for male pattern baldness, J. Investig. Dermatol. 121:1651-1564, 2003.

Media Contact:
Karen Halsey
415-946-1077
Email Contact


SOURCE: Neosil


Edited: 01/05/2007 at 12:08 AM by chrome

nice the osh101 is supposed to be x# times more potent than minoxidil. i am curious to see what daily use will achieve.

-------------------------
http://www.hairlosshelp.com/websites/Harry%20Balls/

There is hope. !!

For those of you that are not aware of the MASSIVE significance of this topical, here is an overview.


A company called Osteoscreen developed OSH101, "a powerful stimulator of new hair growth" a few years ago. It is so poweful that you only need to apply it daily, for 21 days, then STOP.....and watch new hair grow ! (then repeat the 21 day cycle again sometime later). It is now "once-daily over two 14-day treatment periods, which were separated by a one-month drug-free interval."

This is the main topical i have been waiting for for years. It is believed to be VASTLY superior to minoxidil and in a totally different league altogether.

Here are some before/after GIFs:


It was then bought from Osteoscreen by Neosil in January 2005 and we have been waiting for news ever since !

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http://www.osteoscreen.com/projects.html

OsteoScreen identified OSH 101 as a candidate drug for hair re-growth in a proprietary screening program. In animal studies, it was observed that topical administration of OSH101 strongly stimulates dormant hair follicles, increases hair follicle thickness, and overall hair growth. The picture to the right demonstrates the increase in the size and thickness of hair follicles treated topically with OSH101 versus untreated controls. The purple colored bulbs are hair follicles. In the untreated control, the follicles remain small and inactive, while the follicles in the treated group were stimulated and show marked increase in their size and thickness. Treatment with OSH101 for 21 days re-grew healthy, thick hair; whereas the untreated control group barely began to re-grow any hair. OSH101 is a powerful stimulator of new hair growth.

OSH101’s hair growth effect was also compared to the hair growth effect of Rogaine®. The two groups were treated with OSH101 and Rogaine® respectively once per day for five days. After an additional sixteen days elapsed, hair growth was measured. OSH101 resulted in much faster and thicker hair growth than Rogaine®.

Another area of need is chemotherapy-induced hair loss. Many cancer patients who have undergone chemotherapy suffer from acute alopecia. It takes time for the hair to grow back, even after the chemotherapy has ended. The efficacy of OSH101 was determined in a model of chemotherapy-induced baldness. This model is well-described in the medical literature. OSH101 was applied to groups previously treated with cyclophosphamide (a widely-used chemotherapy) to induce hair loss. OSH101 stimulated extremely rapid hair re-growth compared to vehicle alone.

OsteoScreen completed a Phase I Clinical Trial for OSH101 in early 2004. The results were very encouraging. In January 2005, OsteoScreen outlicensed its hair-growth technology to Neosil, Inc., a Northern California based privately held specialty dermatology company that plans to develop the compound into an ethical pharmaceutical. (Click here to read the press release)

Details:

Indication:
Male and female pattern baldness

Technology:
OSH101 (drug for hair growth)

Intellectual Property:
OsteoScreen holds patents for the use of OSH101 for stimulating hair growth.

Status:
1. OSH101 significantly enhanced hair growth in laboratory models by stimulating dormant hair follicles.
2. OSH101 produced superior results to Rogaine® in the same models.
3. OSH101 enhanced hair re-growth in a chemotherapy-induced alopecia model.
4. Non-GLP pre-clinical toxicity studies showed OSH101 is safe.
5. Phase I clinical trials complete.

Possible Indications:
1. Male and Female Pattern Baldness
2. Chemotherapy-induced alopecia.
3. Alopecia areata (autoimmune skin disease resulting in hair loss).
4. Age-related hair thinning.
5. Post-transplant hair re-growth.


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Feb. 16 /PRNewswire/

"Neosil Acquires OsteoScreen’s Hair Technology, OSH 101"

EMERYVILLE, Calif., -- Neosil, Inc., a privately held specialty dermatology company, announced today that it completed in-licensing
of several hair growth products from OsteoScreen, Inc., a private company focused on drug discovery for bone diseases. Terms of the agreement were not disclosed.

" We are quite excited about the OsteoScreen products, one of which has already been in an early-stage human clinical trial in Europe," said Eugene Bauer, M.D., Neosil Chief Executive Officer. "This acquisition adds another topical product to Neosil's existing pipeline of topical anti-bacterial and anti-fungal programs and allows us to leverage our infrastructure to fully exploit complementary areas of competency and expertise, such as microbiology and formulations."

In connection with this in-licensing, Neosil announced that Gregory Mundy, M.D., OsteoScreen founder and Chief Executive Officer, has been appointed to its Board of Directors. A board-certified internist and endocrinologist, Dr. Mundy is Professor of Cellular and Structural Biology and Director of Orthopedic Research at the University of Texas Health Science Center, San Antonio. He is internationally known for his work on osteoporosis and the skeletal complications of cancer. The recipient of a prestigious M.E.R.I.T. Award from the National Institutes of Health (NIH), Dr. Mundy has been an NIH- funded investigator for the past 30 years and has served on both initial review groups and on the Advisory Council of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. He is a member of numerous honorific societies, including the American Society for Clinical Investigation and the Association of American Physicians. He is the current President of the International Bone & Mineral Society.

" I have known and worked with Greg Mundy for many years through our common interests in connective tissue metabolism and through various NIH committees,"commented Dr. Bauer. "He brings an extraordinary depth of knowledge and breadth of experience to Neosil's Board in the cell biology of hair growth. Greg will be an outstanding colleague on Neosil's Board."

About Neosil, Inc.
Neosil, Inc. is a privately held dermatology-focused pharmaceutical company that was funded in November 2004 with a $32 million investment by MPM Capital and Burrill & Company, following initial incubation funding by Shalon Ventures, LP. In addition to Dr. Bauer and Dr. Mundy, Neosil's current Board of Directors includes Nicholas J. Simon, III, General Partner, MPM Capital; Ashley Dombkowski, Ph.D., Partner, MPM Capital; Ann F. Hanham, Ph.D., Managing Director, Burrill & Company; and Teddy Shalon, Managing Director, Shalon Ventures.

About OsteoScreen, Inc.
OsteoScreen Inc., a privately held biotechnology company located in San Antonio, Texas, was founded in 1988 as a joint venture with the University of Texas Health Science Center. The company focuses on the identification and clinical development of new drugs for common diseases of bone. To date OsteoScreen has raised over $35 million through corporate partnering, milestone payments and licensing arrangements with major pharmaceutical companies, including Rorer, Rhone-Poulenc Rorer, ZymoGenetics and Novo Nordisk.


SOURCE Neosil, Inc.
Web Site: http://www.neosil.com

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Edited: 01/04/2007 at 02:22 PM by chrome

Edited: 01/04/2007 at 02:12 PM by chrome

While this is good news i wouldnt break out the champagne and birthday cake just yet until it hits the market and we really see what it can do. Remember how highly touted rogaine and propecia were during trials and studies. now i know rogaine and propecia are good products but they are far far from the end of hair loss as we knew it. i wouldnt be surprised if osh turns out to be just another good topical to ad to KEEP AND MAINTAIN hair.

Commanderfink

I totally disagree....TOTALLY.

this is not your typical crappy maintaining a little bit of hair crap. I believe this to be the real deal, capable of a HUGE leap over Minox etc.

It stimulates BMP.

Here is some research which validates the BMP approach, courtesy of "bug":

Everything can be summed up in three words: Bone Morphogenetic Proteins ( BMP-2, BMP-7 etc)

For a slightly longer yet hopefully concise summary:

BMPs GROW HAIR

Says Who ?
--- Elaine Fuchs
--- http://www.hhmi.org/news/fuchs2.html

--- OsteoScreen/Dr Mundy
--- http://news.mysanantonio.com/story.cfm?xla=saen&xlb=110&xlc=1013894

--- Lion Corp/Tokushima University
--- http://www.asahi.com/english/business/K2003061800557.html


So how do we stimulate BMPs?
--- Proteasome inhibitors(PSI, MG-132, etc)
--- 6-benzylaminopurine(6-BA)
--- Statins (Osteopure(red yeast rice strain)) note: much weaker than PSI


Are there patents that use these substances to stimulate BMPs and grow hair?
--- 6-Benzylaminopurine ---
--- http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=/netahtml/srchnum.htm&r=1
&f=G&l=50&s1=5,656,264.WKU.&OS=PN/5,656,264&RS=PN/5,656,264

--- Proteasome inhibitors ---
--- http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PG01&s1=hair.AB.&s2=proteasome.
AB.&OS=
ABST/hair+AND
+ABST/proteasome&RS=ABST/hair+AND+ABST/proteasome

--- http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=/netahtml/search-adv.htm&r=5&p=1&f=G&l=50&d=ptxt&S1=osteoscreen&OS=osteoscreen
&RS=osteoscreen

and that isnt good? If we can get a new product thats as good as minox or fin?? Dont expect to go from slick bald to full head of hair on any new treatment... Maybe in 10-30 years, who knows... but not now! If its better and more potent than minox, it would be very nice to add to ones regimen...!

Remember Dutasteride? It was all people could talk about long before it was available. All this new stuff looks good until it hits the reality market.

Do we know what's in it? Does anyone have a copy of the patent application?

Edited: 01/04/2007 at 02:32 PM by Side Show Bob

and some more research, courtesy of Lion Corp. they didn't get their version right but the research is still valid:

16 Jun 03:

Japanese company "Lion" release new type of hair-loss treatment using 6-BAP (6-benzyl aminopurine):
http://www.lion.co.jp/en/press/html/2003024f.htm

6-BAP stimulates "bone morphogenetic protein (BMP) and ephrin" to produce a dual effect of increasing hair growth signals AND reducing hair loss signals !

Here are the Lion references from the press release:

Hair Cycle and Androgenic Alopecia
http://www.lion.co.jp/en/press/pdf/pre24-01.pdf

Functions of BMP and EPHRIN on Hair Follicles
http://www.lion.co.jp/en/press/pdf/pre24-03.pdf

Changes in Gene Expression in bald area of AGA
http://www.lion.co.jp/en/press/pdf/pre24-02.pdf

Inhibition of Signal for Hair Loss by 6-benzylaminopurine
http://www.lion.co.jp/en/press/pdf/pre24-05.pdf

Induction of Signal for Hair Growth by 6-benzylaminopurine
http://www.lion.co.jp/en/press/pdf/pre24-04.pdf

Scheme of Effects of 6-benzylaminopurine
http://www.lion.co.jp/en/press/pdf/pre24-06.pdf

Here is Dr Elaine Fuchs take on BMPs for hair growth:
http://www.hhmi.org/news/fuchs2.html

March 20, 2003
Researchers Identify Signals that Cause Hair Follicles to Sprout
The delicate interplay of two chemical signals coaxes stem cells into becoming hair follicles, according to new research by scientists at the Howard Hughes Medical Institute at The Rockefeller University.

The research has implications for understanding hair growth and hair-follicle development, and it may also help explain how diverse structures, such as teeth and lungs, are formed or how some forms of skin cancer develop.


“These studies raise the possibility that drugs to activate these natural factors could promote hair follicle growth.”
Elaine Fuchs

In an article published in the March 20, 2003, issue of the journal Nature , researchers led by HHMI investigator Elaine Fuchs at The Rockefeller University discovered that two signaling molecules, Wnt and noggin, influence immature stem cells to begin the process of forming hair follicles.

According to Fuchs, studies in her laboratory and others revealed the possible involvement of Wnt and other proteins in the signal transduction pathways that trigger hair-follicle formation. In previous studies, Fuchs and her colleagues produced an abnormally furry mouse with high numbers of hair follicles by genetically altering the animals to produce a stabilized form of a protein called beta-catenin. They also knew that beta-catenin was affected by the Wnt protein. Among the other proteins they implicated in hair-follicle formation was “lymphoid enhancer-binding factor 1” (Lef1), which is part of a transcription complex that controls gene activity.

“One of the aspects that scientists have been trying to understand in development of hair follicles, tooth buds, mammary glands and lungs is how these various transduction pathways work together,” said Fuchs.

The researchers also had evidence that a second mechanism, involving a signaling molecule called bone morphogenetic protein (BMP), is also required for creating epithelial buds—pockets in the skin that are the precursors of hair follicles.

Through experiments using mouse skin cell cultures and skin from embryonic mice with various genes knocked out, the researchers showed that Wnt stabilizes beta-catenin and increases its concentrations in the target stem cell. In concert, noggin inhibits BMP, leading to production of Lef1. In addition, beta-catenin activates Lef1, which in turn downregulates the gene for the protein E-cadherin. E-cadherin is important in cell adhesion. Reduced levels of E-cadherin trigger reduction of cell adhesion structures, called adherens junctions, a process important in initiating formation of the epithelial bud.

“Unlike the earlier experiments, in which we genetically altered the animals, in these experiments, we have altered the stem cells using external factors that the skin normally makes,” said Fuchs. “And in doing so, we have been able to elicit the initial responses that occur in the development of the hair follicles.

“The other important advance is that we now understand how Wnt and inhibition of the BMP signaling pathway work together by regulating this transcription factor complex. The discovery provides insights into how signals simultaneously operate together to activate a particular event, in this case, a transcription factor.”

The findings also hint at how different kinds of cells interact to produce epithelial buds, said Fuchs. “These signals are probably coming from different cells within the skin,” said Fuchs. “The Wnt pathway is likely coming from adjacent epithelial cells, and the noggin pathway from mesenchymal cells. But, they're working together on a single skin stem cell to produce an activated transcription factor.” Mesenchymal cells are unspecialized cells in embryonic skin from which the dermis will develop.

“How these signal transduction pathways are merging was not understood before, and we now have a much clearer picture of why they need to be there at the same place and time in the developing skin,” said Fuchs.

According to Fuchs, the findings also have implications for understanding how some forms of skin cancer arise. “Our studies suggest that too much or too little E-cadherin can be a bad thing,” she said. “Just the right amount of E-cadherin is needed to loosen the adhesion of the stem cells in the epithelium, to allow them to remodel and grow downward to form the hair follicle. What's interesting is researchers have found reduced levels of adherens junctions in squamous cell carcinomas of the skin. So, we think our findings may be relevant, because they suggest that if the E-cadherin levels are reduced too much, there can still be a downgrowth of the skin, but one that's deregulated. The early stages of hair follicle morphogenesis resemble, to some extent, what happens in the development of a tumor mass.”

The studies in Fuchs's laboratory seek to understand fundamental aspects of hair follicle formation, which could eventually suggest new ways to restore or inhibit hair growth. “These studies raise the possibility that drugs to activate these natural factors could promote hair follicle growth in wanted places, and inhibitory drugs could prevent hair growth in unwanted places,” she said.

Among the next steps in the research, said Fuchs, is to understand how the newly discovered machinery involved in epithelial bud formation links to the later steps that causes mature hair-producing follicles to sprout.

Chrome, in your opinion...how long does it generally take for a product to go from Phase2a trials to market? Is this something we could see in a year or two or is it much further down the road? This sounds VERY promising and significantly different than any current treatments.

Any chance it would be available in Europe before the US since clinical trials were done in Europe? Would it have to start all over again and go through the FDA approval for US?

I'm sorry guys, but this really is in a totally different league to minoxidil et al.

The only worry at the time when this story broke a couple of years ago was the possibility that it may stimulate cancerous cells as it was so powerful a topical. This is still my main concern but it seems to have got as far as Phase 2a without any problems which i find very encouraging.

"Phase 2 trials include more participants (about 100-300) who have the disease or condition that the product potentially could treat. In Phase 2 trials, researchers seek to gather further safety data and preliminary evidence of the drug's beneficial effects (efficacy), and they develop and refine research methods for future trials with this drug. If the Phase 2 trials indicate that the drug may be effective--and the risks are considered acceptable, given the observed efficacy and the severity of the disease--the drug moves to Phase 3."

THIS IS NOT YOUR TYPICAL LAME CRAP.

Edited: 01/04/2007 at 02:48 PM by chrome

worriedwoman,

Unfortunately, its still many years away as it still needs to complete the expensive/long winded Phase 3 trials.

The reason i am so excited about todays news is that i was losing hope reSH101 due to a total lack of news. I was beginning to think this had fallen by the wayside as well hence my utter delight to see that it has completed Phase 2a very successfully !



From the FDA website:
http://www.fda.gov/fdac/features/2003/503_trial.html

What Happens in a Clinical Trial?
Every clinical trial is carefully designed to answer certain research questions. A trial plan called a "protocol" maps out what study procedures will be done, by whom, and why. Products are often tested to see how they compare to standard treatments or to no treatment. The FDA often provides extensive technical assistance to researchers conducting clinical trials, helping them design better trials that can characterize effects of a new product more efficiently, while reducing risks to those participating in the trials.

The clinical trial team includes doctors and nurses as well as other health care professionals. This team checks the health of the participant at the beginning of the trial and assesses whether that person is eligible to participate. Those found to be eligible--and who agree to participate--are given specific instructions, and then monitored and carefully assessed during the trial and after it is completed.

Done at hospitals and research centers around the country, clinical trials are conducted in phases. Phase 1 trials try to determine dosing, document how a drug is metabolized and excreted, and identify acute side effects. Usually, a small number of healthy volunteers (between 20 and 80) are used in Phase 1 trials.

Phase 2 trials include more participants (about 100-300) who have the disease or condition that the product potentially could treat. In Phase 2 trials, researchers seek to gather further safety data and preliminary evidence of the drug's beneficial effects (efficacy), and they develop and refine research methods for future trials with this drug. If the Phase 2 trials indicate that the drug may be effective--and the risks are considered acceptable, given the observed efficacy and the severity of the disease--the drug moves to Phase 3.

In Phase 3 trials, the drug is studied in a larger number of people with the disease (approximately 1,000-3,000). This phase further tests the product's effectiveness, monitors side effects, and, in some cases, compares the product's effects to a standard treatment, if one is already available. As more and more participants are tested over longer periods of time, the less common side effects are more likely to be revealed.

Sometimes, Phase 4 trials are conducted after a product is already approved and on the market to find out more about the treatment's long-term risks, benefits, and optimal use, or to test the product in different populations of people, such as children.

Phase 2 and Phase 3 clinical trials generally involve a "control" standard. In many studies, one group of volunteers will be given an experimental or "test" drug or treatment, while the control group is given either a standard treatment for the illness or an inactive pill, liquid or powder that has no treatment value (placebo). This control group provides a basis for comparison for assessing effects of the test treatment. In some studies, the control group will receive a placebo instead of an active drug or treatment. In other cases, it is considered unethical to use placebos, particularly if an effective treatment is available. Withholding treatment (even for a short time) would subject research participants to unreasonable risks.

The treatment each trial participant receives is often decided by a process called "randomization." This process can be compared to a coin toss that is done by computer. During clinical trials, no one likely knows which therapy is better, and randomization assures that treatment selection will be free of any preference a physician may have. Randomization increases the likelihood that the groups of people receiving the test drug or control are comparable at the start of the trial, enabling comparisons in health status between groups of patients who participated in the trial.

In conjunction with randomization, a feature known as "blinding" helps ensure that bias doesn't distort the conduct of a trial or the interpretation of its results. Single-blinding means the participant does not know whether he or she is receiving the experimental drug, an established treatment for that disease, or a placebo. In a single-blinded trial, the research team does know what the participant is receiving.

A double-blind trial means that neither the participant nor the research team knows during the trial which participants receive the experimental drug. The patient will usually find out what he or she received at a pre-specified time in the trial.


Edited: 01/04/2007 at 02:52 PM by chrome

Great breaker Chrome. Thank you for the heads up.

Thanks Chrome, but I'm still not clear.

The Phase 2 trials you posted were conducted in Europe. Would the FDA accept those European results or begin their own process starting at Phase 1 again? Makes me think OSH 101 would be available in Europe before the US. (Of course, if the company holding the patent is a US-based company, it would probably be green-lighted faster than if it's non-US.)

Chrome,

Ok...it's going to be a while. Crap. Thanks.

Quote

---

A statistically significant increase in total hair count (4.8%, p=0.04), and cumulative hair thickness (3.7%, p=0.02

---

... Under 5%? Doesn't sound like much to me!

My mother has a very rare form of cancer and on 2 occasions our doctor has been hopeful of new drugs that were off on the horizon---still in their trials. They actually came to be on the market relatively quickly and a hell of a lot faster than I would have ever expected. They were both within a year if I remember correctly.

So possibly this could be out sooner than one would think

madclown,

Are you kidding ?

Read it again !


The "statistically significant increase in total hair count of 4.8%" was achieved after just 28 days topical application,once per day only !!!


"once-daily topical treatments of NEOSH101 or placebo over two 14-day treatment periods, which were separated by a one-month drug-free interval."

Its phenomenol.

Try applying Minoxidil once a day for 14 days, have a 1 month break, then apply again for another 14 days and see how much hair growth you get !








Edited: 01/04/2007 at 03:23 PM by chrome