Peplin to buy Neosil in Oct 2008

[chrome]

Peplin to buy Neosil in Oct 2008
http://www.tmcnet.com/usubmit/-pepl...d-phase-iii-keratosis-/2008/08/19/3609672.htm

"While PEP005 moves through the clinic, Peplin is expanding its pipeline through the acquisition of Emeryville, Calif.-based Neosil Inc. In exchange for $6.7 million in stock, Peplin will get Neosil's Phase II hair growth product and early stage antimicrobial agent for acne.

Both the acquisition and the private placement are subject to shareholder approval. A shareholder meeting will be held in October."


-------------------------------------------------


http://www.neosil.com

NEOSIL ANNOUNCES POSITIVE PHASE 2 DATA FOR NEOSH101, AN INVESTIGATIONAL TREATMENT FOR ANDROGENETIC ALOPECIA

Emeryville, CA – January 4, 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,â€￾ 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,â€￾ 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.â€￾

 

[Noobie]

When will this EVER come out?!!? :dunno:

 

[justaguy2005]

Must mean it doesn't work -- they bought the company for cash on hand and fired everyone in the US. Those P2b trial #s must have said that this is no better than minoxidil.

 

[khali]

2013 is the current time line for hair loss drugs.

 

[chrome]

Peplin completes aquisition of Neosil - 20 Oct 2008

http://www.peplin.com/pdf/20-Oct-08_media.pdf

Peplin’s acquisition of Neosil complete

EMERYVILLE, California and BRISBANE, Queensland, 20 October 2008: Peplin, Inc. (ASXLI) announced today that it has completed its previously announced acquisition of Neosil, a privately-held, dermatology-focused company,in an all stock transaction for US$6.7m after receiving shareholder approval at the AGM on 6 October.

Shareholders also approved the private placement of common stock and warrants to raise approximately US$24 million as previously announced on 19 August 2008. Peplin anticipates that the total combined cash balance of US$56 million (pro-forma at 30 June 2008) will be sufficient to fund completion of the ongoing Phase III testing of Peplin’s lead product, PEP005 (ingenol mebutate) Gel for actinic keratosis (AK) on both head and non-head treatment sites.

The Neosil purchase price of US$6.7 million in shares of Peplin stock represents the amount of net cash held by Neosil at signing. Peplin shares were valued based on the volume weighted 10-day trailing average closing price of Peplin’s CDI’s on the Australian Securities Exchange (ASX) immediately preceding the signing of the agreement in June (A$0.4256). Peplin issued approximately 819,000 shares of its common stock (equivalent to approximately 16.4 million CHESS Depository Interests or CDIs) in exchange for the all equity interests of Neosil. Neosil shareholders now own approximately 7.3% of Peplin following completion of the transaction.

In addition to its net cash, Peplin acquires Neosil’s intellectual property portfolio which comprises two early clinical stage development programs: the first a hair growth stimulation technology with potential application in the treatment of hair loss and the second, a broad spectrum anti-microbial technology with potential application in the treatment of acne.Peplin does not expect to commence further development of these programs before 2009.


ABOUT PEPLIN

Peplin is a development-stage, specialty pharmaceutical company focused on advancing and
commercialising innovative medical dermatology products. Peplin has offices in Brisbane,
Queensland and Emeryville, California and a manufacturing facility in Southport, Queensland.
Peplin is currently developing PEP005 (ingenol mebutate), which is the first in a new class of
compounds and which is derived from the sap of Euphorbia peplus, or E. peplus, a rapidly
growing, readily available plant commonly referred to as petty spurge or radium weed. E.
peplus has a long history of traditional use for a variety of conditions, including the topical
self-treatment of various skin disorders, including skin cancer and pre-cancerous skin lesions.
Peplin’s lead product candidate is a patient-applied topical gel containing ingenol mebutate, a
compound the use of which Peplin has patented for the treatment of actinic keratosis, or AK.
This product candidate is now in Phase III clinical trials and is referred to as PEP005 (ingenol
mebutate) Gel.

ABOUT ACTINIC KERATOSES
Actinic (solar) keratoses (AK) is generally considered the most common pre-cancerous skin
condition. AK usually appears as small, rough, scaly areas on the face, lips, ears, back of
hands, forearms, scalp or neck. If left untreated, AK lesions may progress to a form of skin
cancer called squamous cell carcinoma, or SCC. The Lewin Group, Inc., estimates that the
total direct costs for AK in the United States was $1.2 billion in 2004, and in 2002 there were
approximately 8.2 million office visits for the treatment of AK. The Lewin Group also estimated
that there were 58 million people in the United States living with AK in 2004. According to a
May 2006 issue of The Journal of Family Practice, in northern hemisphere populations, 11%
to 25% of adults have at least one AK lesion, compared with 40% to 60% of adults in
Australia, which has the highest prevalence of AK worldwide.

 

[SoThatsLife]

As to my understanding this product is just similar to minoxidil, but it could maybe give a little more regrowth and be a little more effective. I remember reading somewhere that it didn't need to be applied as often as minoxidil and that would be nice, since the hassle of applying seems to be one of the most common reasons for quiting minoxidil.

 

[chrome]

This is far superior to minoxidil.

If you read the above it says they 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."

This is used once a day for 14 days, then a 1 month break before once a day for a further 14 days.

Can you imagine the minoxidil results if applied once a day for 14 days, having a 1 month break then applying once a day for 14 more days ?

This is far superior to minoxidil. if the above is correct.

 

[SoThatsLife]

If its superior to minoxidil is something we wouldnt know before they release their numbers or show us some pics. I remember Mr. Barry posted some numbers many, many months ago, that wasnt all that impressive, but we dont know if they tested in on people that was slick bald or people that was thinning.

If it works well, it would be so nice that a big pharm company bought the Neosil patent and the ASCJ-9(if it works well) and combined them in one topical. Off course, this will never happend, but it would be a real nice treatment, if both products work well.

 

[chrome]

We DO know.

Neosil had hair growth just by applying it once a day for 14 days, having a 1 month break, then applying for just 14 more days, then wait for 8 weeks.

What sort of growth would you get if you applied minoxidil this way ?

NONE.

It IS far superior to minoxidil.

 

[chrome]

Neosil Patent (originally bought from Osteoscreen):

Inhibitors of proteasomal activity for stimulating hair growth - 29.05.2007
United States Patent 7223554
http://www.freepatentsonline.com/7223554.html

EXAMPLE 9
Stimulation of Hair Growth
Male Swiss ICR mice were first treated to remove hair from the scalp and dorsal regions as follows. Paraffin wax was liquefied by heating to 55° C. and the liquefied wax then applied by brush to the scalp and/or back (under anesthesia). The wax was allowed to solidify and then removed. The day following hair stripping, PSI (1 mg/kg/day) was injected subcutaneously three times a day for five days into the scalp and dorsal region. On day 7 a dermal punch biopsy was taken; histology revealed a large increase in the number of hair follicles in mice administered PSI versus control mice. By day 18, it was observable that the treated mice had a hair growth rate greater than that of the mice in the control group.

The mice were sacrificed on day 21 and histology was performed on the dermis of the scalp and of the dorsal region. In the treated mice, mature hair follicles in numbers much greater than in controls had migrated to the lower region of the dermis. Upon closer examination, it was observed that mice that had received only vehicle had quiescent hair follicles. When treated with PSI such follicles were stimulated to differentiate into mature hair follicles and to migrate to the lower region of the dermis.

EXAMPLE 12
Anagen Effect
Inhibitors of the proteasomal chymotrypsin-like activity were treated for their capacity to induce transit of hair follicles into anagen in vivo in C57 black mice eight weeks of age. Epoxomicin, PSI (5 mg/kg/day) or PSI-epoxide (10 mg/kg/day) was injected subcutaneously in the scalp daily for 5 days, and the underlying tissue examined 16 days later. All three compounds increased hair follicle differentiation in vivo. In contrast, NF-?B inhibitors calpain inhibitor-I PDTC and 2-benzoylamino-1,4-naphthoguinone (PPM-18), as well as the statins lovastatin and simvastatin, have no effects on proteasomal activity (Law, R. E, et al., Mol Cell Biol (1992) 12:103–111; Guijarro, C., et al., Nephrol Dial Transplant (1996) 11:990–996). Lovastatin and simvastatin injected locally into the subcutaneous tissue in sufficient concentrations to cause local periosteal-bone formation (Mundy, G., et al., Science (1999) 286:1946–1949), had no effect on hair follicles. Calpain inhibitor-I, PDTC and PPM-18 also had no effect on hair follicles.

These data suggest that only those compounds that cause inhibition of proteasome function stimulate induction of anagen in quiescent hair follicles in vivo.

EXAMPLE 13
Topical Administration
PSI was prepared as a topical formulation, where the vehicle was 50% propylene glycol, 30% ethanol, 20% deionized water, at 0.1% concentration of PSI. The solution was applied 3 times a day for 5 days. The mice in a treated group were observed as compared to controls similarly treated with vehicle alone. The results at day 16 showed stimulation of hair growth relative to the controls.

In addition to stimulating hair growth, PSI was able to thicken both the hair and the hair shaft. PSI increases hair count when the follicle area is greater than 0.01 mm 2 . When the protocol above was repeated using a 0.5% solution of PSI in groups containing 5 mice each, the number of hairs per 0.8 mm 2 was 60 in the treated mice versus about 10 in the control group. The percentage of follicle area in a region of about 0.8 mm 2 was about 30% as an average in the treated group as compared to 15% as an average in the control group.

EXAMPLE 16
Effect of Hair Cycle Stage
Skin explants from mice during telogen at 3 weeks of age were cultured for 72 hours, in the presence of proteasome inhibitors, and then the explants were histologically examined. In the untreated control explants, the follicles were few and small. In the explants treated with PSI (50 nM), epoxomicin (25 nM), and the hybrid PSI-epoxide (50 nM), there was an obvious increase in hair follicle diameter, and follicle elongation. Minoxidil also caused these changes, but at concentrations 10,000-fold greater. Since these small follicles resemble the miniaturized follicles seen in male pattern baldness, this suggests these compounds may have the same effects in that situation.

 

[chrome]

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

 

[chrome]

Dose-Ranging Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss - May 07 - Feb 08
http://clinicaltrials.gov/ct2/show/NCT00471510?spons="Neosil,+Inc."&spons_ex=Y&rank=1

Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss - Jan 07 - Apr 08
http://clinicaltrials.gov/ct2/show/NCT00418730?spons="Neosil,+Inc."&spons_ex=Y&rank=2

 

[chrome]

Here is the original info from Osteoscreens "Project" page on their ebsite (no longer available):

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

A New Treatment for Hair Loss

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.

 

[Night]

I'm interested in the product, if it ever comes out

I wonder if it has the same, if you don't use the product it dies etc like Propecia/Rogaine?

From the sound of it, it might not.

 

[SoThatsLife]

Thanks Chrome, that was exciting stuff to read.

But again, they have been working on this product for ages, so something is not optimal yet. 2013 is a long time to wait.

 

[chrome]

SoThatsLife

It appears to be just a matter of money again unfortunately. In the current crisis they are only concentrating on their lead product. They only bought Neosil because of its cash, the products were just a nice bonus.

If i were a multi-millionaire i would try and fund something like this so i get first dibs and make a mint as well.