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Javelin Pharmaceuticals Announces Successful Pivotal Phase 3 Trial Data
Tuesday June 19, 8:40 am ET
Rylomine(TM) Meets Primary Endpoint, Significantly Reduces Postsurgical Orthopedic Pain
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Javelin Pharmaceuticals (AMEX: JAV - News) announced today that its product candidate Rylomine(TM) (intranasal morphine) successfully met its primary clinical endpoint, the Sum of the Pain Intensity Difference (SPID) scores over 0-24 hours postoperatively. In this first of two pivotal Phase 3 studies, patients with moderate-to-severe pain after elective orthopedic surgery were given 7.5 mg Rylomine every hour as needed, 15 mg Rylomine every 3 hours as needed, or 7.5 mg intravenous (IV) morphine every 3 hours as needed. Patients in each of the three active treatment groups had significantly better (p less than .01 or less) SPID scores over 24 hours than the corresponding placebo groups.
"Parenteral morphine is the gold standard for postoperative analgesia," commented Dr. Daniel B. Carr, CEO and CMO of Javelin Pharmaceuticals. "Today's gratifying results extend our prior positive study findings showing that Rylomine is a simple, effective alternative to more complex, cumbersome and costly methods of postoperative opioid analgesia. We look forward to continuing the development of this innovative product candidate."
There were no serious adverse events related to the study drug. Local adverse events associated with nasal administration (bad taste, throat irritation, instillation site reaction, nasal erythema, nasal irritation) were more common with Rylomine or intranasal placebo than the intravenous morphine groups. General systemic adverse events related to active drug were similar across morphine treatment groups regardless of route of administration and consistent with morphine's known pharmacologic effects (dizziness, nausea, transient decreased oxygen saturation, and vomiting).
Full analyses of the data are ongoing and will be reported when available.
About the Study
This study, termed MOR-003, involved 278 randomized patients with moderate to severe post-surgical pain enrolled at 7 sites in the United States. These patients received either 7.5 mg Rylomine every hour as needed, 15 mg Rylomine every three hours as needed, 7.5 mg IV morphine, or matching placebos. In this "blinded" study, patients received treatments of which the identity (active or placebo) was not known by either the Investigator or the patient, although patients did know whether they were receiving intravenous or intranasal treatment.
About Rylomine(TM)
Rylomine is a patient-controlled nasal spray that delivers a single metered dose of morphine, an opioid analgesic used for the treatment of moderate-to-severe pain. After use, a negligible amount of morphine remains in the dispenser, reducing the risk of scavenging and abuse of discarded devices. Data from clinical studies have demonstrated that Rylomine has similar efficacy to an infusion of intravenous morphine.
Parenteral morphine is the standard of care for management of acute moderate-to-severe pain, especially after surgery, when analgesic requirements vary between individuals and often fluctuate even in the same patient. IV morphine analgesia has rapid onset, proven efficacy, can accommodate variations in analgesic demand, and has side effects that are well understood by medical personnel. Morphine, like many drugs, is poorly absorbed across mucosal barriers and, in particular, the nasal membrane. Javelin's proprietary technology allows for nasal delivery of predictable therapeutic blood levels of morphine. The key to this technology is ChiSys(TM), a carbohydrate polymer that, while pharmaceutically inert by itself, enhances the absorption of compounds across mucosal membranes, such as in the nasal cavity. The contribution of ChiSys(TM) to enhancing mucosal drug absorption reflects several factors including its potent mucoadhesive property, which prevents drug washout. Rylomine is a novel formulation of morphine and ChiSys(TM) packaged in a single unit-dose nasal spray. Worldwide, no comparable formulation of morphine is available.
About Javelin Pharmaceuticals, Inc.
With US corporate headquarters in Cambridge, MA, and a European office in Cambridge, UK, Javelin applies innovative proprietary technologies to develop new drugs and improved formulations of existing drugs to target unmet and underserved medical needs in the pain management market. For additional information, please visit www.javelinpharmaceuticals.com.
Forward-looking Statement
This press release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA (and foreign equivalent) review process and other governmental regulation, our ability to obtain working capital, our ability to successfully develop and commercialize drug candidates, and competition from other pharmaceutical companies.
JAV-G
Contact:
Javelin Pharmaceuticals, Inc.
Investor Relations & Media
Rick Pierce, 617-349-4500
VP Investor Relations
rpierce@javelinpharmaceuticals.com
or
Corporate Communications
June Gregg, 617-349-4500
jgregg@javelinpharmaceuticals.com
Fax: 617-349-4505
--------------------------------------------------------------------------------
Source: Javelin Pharmaceuticals, Inc.
http://biz.yahoo.com/bw/070619/20070619005272.html?.v=1
Mpower, nice sensible post. EOM
OT: Selling puts on AMGN and other large caps - this is from Barron's.
A Strategy Built for Bulls
By STEVEN M. SEARS
OPPORTUNITY OFTEN RESIDES between contradiction and fear.
As bond yields rise and the volatility of many equity options floats higher in anticipation that stocks may go lower, a paradoxical trade is emerging, just as the second-quarter earnings season begins. Goldman Sachs' wily options strategists recommend selling put options to express a bullish view on mega-cap stocks, even as some investors fret that stocks will slip during the lazy days of summer.
The rationale for this seemingly contrarian trade is a market call by Goldman's portfolio strategist, who thinks stocks may advance into the summer because investor expectations are too conservative, especially for big companies. Sound familiar? First-quarter profits also were expected to be lackluster. But they beat expectations, helping to propel stocks to new highs.
Many stocks have recovered nicely since the recent 3% decline in the S&P 500, yet Goldman's options strategists, Maria Grant and John Marshall, have identified 15 mega-caps with elevated options prices, and strong fundamentals that are worth betting on. After screening their universe of liquid options -- about 350 names -- they found that the implied volatility of stocks with market capitalizations above $40 billion were significantly higher than that of smaller issues. These stocks' implied volatility -- essentially, price -- had risen, on average, 5.1% in the previous week, versus 2.7% for smaller stocks. Implied volatility also is higher for mega-caps than it is elsewhere in the market.
To benefit from these discrepancies, the strategists recommend selling three-month puts on Target (TGT), AT&T (T), PepsiCo (PEP), Coca-Cola (KO), Comcast (CMCSA), Oracle (ORCL), Sears (S), IBM (IBM), Wells Fargo (WFC), Merrill Lynch (MER), Johnson & Johnson (JNJ), Morgan Stanley (MS), Amgen (AMGN), General Electric (GE), and Disney (DIS).
To qualify for the list, stocks had to be rated Buy by Goldman's equity analysts, have three-month volatility among the most expensive of the past year and boast a market value above $40 billion. Target's three-month options volatility, for example, is at its highest level of the year, and AT&T, Pepsi and Coca-Cola options aren't far behind.
Goldman's portfolio strategist, David Kostin, believes second- quarter consensus earnings estimates are too low. He views large-caps as more attractive than small-caps, in part because big stocks have about double the exposure to fast-growing international markets, and this helped them report better-than-expected first-quarter net. Moreover, large-caps are less sensitive to interest rates and widening credit spreads, owing to their generally well-managed balanced sheets. In addition, based on measures such as price-to-earnings and price-to-book ratios, large-caps are at the bottom of their 20-year average, and hedge funds "have recently began to shift" into large- and mid-cap stocks and away from small-caps.
If the trades work, investors will be in for an end of summer treat. If not, they'll get a chance to own some good stocks, and that's not bad either.
--------------------------------------------------------------------------------
io_io, thanks for your reply. I realize we differ on opinions whether TA has an effect on trading of biotechs like rprx, however the chart I showed you speaks for itself in terms of support and resistance levels. ;)
Investor Business Daily now has RPRX as a 'C' for accumulation; it was an A two weeks ago, so there has been some distribution. Hope it moves back up to B and higher shortly.
I would also like to see rprx above their 50 dma on Monday.....and some bargain buying by longs.
good luck
TA Answers to io_io's Qs
1. Yes I believe TA can still apply even for thinly traded biotechs like RPRX. When RPRX broke down after their secondary it did settle near the 200 exp day moving avg before ramping back up. And after breaking through 50 dma that became its new support. (see link below)
2. Yes, same answer as in #1. Regardless, as with any stock, PR of significant news can move a stock up or down regardless of technicals.
http://finance.yahoo.com/q/ta?s=RPRX&t=3m&l=on&z=m&q=b&p=m200,b,e50,e100,e200&am....
Bio_pete, I agree with you. Also, do you have any insights on what David M. may have said after the recent Proellex endo news, and selloff??
In addition to the OE, I believe some of the hedge funds are just locking in their gains after buying the stock in the 10's region and getting both the Androxal and Proellex news. Too bad it is happening, but they play the quarterly performance game.
Happy Father's Day to all Fathers!
Jonathan, the chart is there if you wait a few seconds. it will pop up below Dead's post. I hope he isn't right about the negative trend direction for RPRX but one can't consider it out of the possibilities.
blackcat: Your welcome, I hope! Congrats on getting some rprx in the mid to upper 12's.
I believe it is just a matter of time before RPRX is more fairly valued. Even their CEO Joe P. didn't expect the price of the stock to really take off until this fall. We'll see....I really am not comfortable predicting nearterm price movement in a thinly traded stock.
Here is an interesting TA bearish opinion I found on Dew's IHUB board for RPRX. I really don't have an opinion on whether the nearterm action could take us another 2 points lower or not. But....anything's open in this biotech world.
http://www.investorshub.com/boards/read_msg.asp?message_id=20503151
Best wishes and good luck with your investments. I assume you've done very well with ELN.
Regards,
Spartex
As for the option expiration Max Pain pullback, I maintain that this was not really a factor on account of the small open interest compared to the trading, but it was nevertheless used by the shorts as a psychological warfare to make it happen: sort of a self-fulfilling prophecy: if enough people have been programmed to believe it will happen, then these people make it happen artificially because of their reactions...
Hmm, classic Croumagnon! Rather than admit that my opinions on OE controlling RPRX's price this week he pulls the "shorts as a psychological warfare to make it happen" out of his hat! I love it! ;) Crou, you need to stop this sillyness before you are put on more "ignore" lists here on IHUB. Good luck with your AMGN 55 puts.
Crou: I wish you well, because obviously you are weaving a lot of yarn on this board and Dew's IHUB. I'm done stating my reasoned opinions back to you. They were fairly stated and had empirical points to support them. You continue to spin a lot of yarn. I hope it gets you to the promised land. LOL.
OT: Bio_Pete, been doing some hiking in the Rocky Mtn Nat Park this past week. Unfortunately my believe that RPRX was being controlled by the 12.5 June OE strike repeated itself in June like it did in May. Oh well..... not sure if July will only take us to the $15's before more substantive news in later in July and August on Proellex safety and FDA meetings on Androxal.
Well, I missed POZN. Congrats on your success with them!
Spartex
Crou- first you dis my prediction that RPRX would trade back down to 12.5 strike in June OE like it did last month. Now you are pumping speculation that RPRX will announce a buyout tomorrow (Sat) at $50. I would rather you take this IV type speculation back to the IV board, not here on IHUB. It is really unfounded, and total BS imho.
BS croumagnon. you don't know what you are talking about. It HAPPENED (RPRX pulled back from 13.2's to 12.5) into the May options expiration. What is your purpose here to blow smoke or chaff? I'm finished trying to give you my personal opinions based some empirical evidence.
RPRX - croumag, the price action or RPRX looks like it is being affected by this Friday's options expiration.
The stock could drift down towards 12.5, allowing both the option writers of the 12.5 and 15 calls to keep their stock and $$$. Happened last month.
Bio_Pete and others......
In my opinion I believe the reason for the minor selloff today was due to:
1) Sell on the news reaction
2) Market sell off today
3) Options expiration this Friday
The volume was a bit above average for today but no way near anything to cause alarm. Bottom line is that this damn company continues to build a foundation of solid efficacy and safety results to support a market cap value of $500 mil +++ over the next 6 months.
Stay cool!
Spartex
Where do they get these idiots?
Somewhere in New Jeeeerseeeey, the state where I grew up in. LOL. :) Probably the usually rush-job write ups that seem to happen with the internet time game. Some attention to detail and accuracy would be nice!
Thanks rfj for doing any additional writeups on RPRX events between today and this fall. I'm very pleased Joe P. put out the news when it was literally ready, versus the usual 6 am release.
Best wishes to RPRX longs and RPRX with their significant progress to date.
CRTX --
I am holding but will buy more when he is out.
Thanks for your insights. Question: shouldn't you be buying more CRTX stock while there is overhang from "prospect partners" which is keeping the price lower? Or do you expect the selling to drive the shares down ever lower to $2 before the seller is done? After the seller is gone the price will bounce up and I'd hate to chase the price as it rises quickly.
Thanks again for your thoughts on CRTX as well as your info on REGN from analysts.
Spartex
REGN- thanks Dew. This is what makes a market. I believe in the value of VEGF as the clinical data continues to unfolds. I don't only look at the data, but also the quality of REGN's management and their partnerships.
Since Nov 06 I'm up 500% on my principle through strategic use of margin, and I hope my trend continues. fyi, I'm out of IDIX for now, with most of my portfolio focused on RPRX, REGN, and a lesser amount on DNDN.
Good luck,
Spartex
Regeneron Submits Biologics License Application to U.S. FDA for IL-1 Trap (Rilonacept) for Treatment of CAPS
Friday June 8, 7:00 am ET
IL-1 Trap is First Regeneron Investigational Drug Submitted to FDA for Marketing Approval
TARRYTOWN, N.Y.--(BUSINESS WIRE)--Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN - News) announced that it has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the Interleukin-1 (IL-1) Trap (rilonacept) for the long-term treatment of Cryopyrin-Associated Periodic Syndromes (CAPS). CAPS is a spectrum of rare inherited inflammatory conditions, including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome.
As part of the BLA submission, Regeneron has requested a Priority Review from the FDA, which, if granted, would provide a target for the FDA to complete their review within six months from their receipt of the submission under current guidelines. The FDA has previously granted Orphan Drug status and Fast Track designation to the IL-1 Trap for the treatment of CAPS.
"Currently, there are no medicines approved for patients suffering from CAPS, and we are hopeful that the IL-1 Trap will play an important role in the future treatment of this rare condition," said Leonard S. Schleifer, M.D., Ph.D., Regeneron's president and chief executive officer. "This submission marks a major corporate milestone for Regeneron. I want to express my appreciation for the hard work and dedication shown by the many people at Regeneron who discovered and developed the IL-1 Trap and completed the submission of this, our first BLA."
About the Interleukin-1 and the IL-1 Trap (rilonacept)
Interleukin-1 (IL-1) is a protein secreted by certain cells in the body. In many cases, IL-1 acts as a messenger to help regulate immune and inflammatory responses by attaching to cell-surface receptors in cells that participate in the body's immune system. In excess, it can be harmful and has been shown to be a key driver of inflammation in a variety of diseases, including CAPS.
The IL-1 Trap is a potent, long-acting inhibitor of IL-1. It is designed to attach to and neutralize IL-1 in the blood stream before it can attach to cell-surface receptors and generate signals that can trigger disease activity in body tissue. Once attached to the Trap, IL-1 cannot bind to the cell surface receptors and, together with the Trap, is flushed from the body.
Regeneron has completed a Phase 3 program evaluating self-administration by weekly subcutaneous injection of the IL-1 Trap in patients with CAPS. It is also conducting a proof-of-concept study of the IL-1 Trap in patients with gout.
About Cryopyrin-Associated Periodic Syndromes (CAPS)
Cryopyrin-Associated Periodic Syndromes (CAPS) is a spectrum of rare inherited inflammatory conditions, including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS). These autoinflammatory diseases are characterized by spontaneous systemic inflammation. Inflammatory symptoms in patients with FCAS and MWS include fever, chills, rash, fatigue, joint pain, and eye redness. Currently, there are no medicines approved for the treatment of CAPS.
CAPS is caused by a range of mutations in the gene CIAS1 (also known as NALP3) which encodes a protein named cryopyrin. This gene, and its causal relationship to FCAS and MWS, was discovered by Dr. Hal Hoffman and colleagues at the University of California at San Diego. Dr. Hoffman and others have studied the ability of IL-1 blocking agents to reduce signs and symptoms of CAPS, and Dr. Hoffman served as the key advisor in the design and conduct of the Phase 3 IL-1 Trap CAPS program.
About Regeneron Pharmaceuticals
Regeneron is a biopharmaceutical company that discovers, develops, and intends to commercialize therapeutic medicines for the treatment of serious medical conditions. Regeneron has therapeutic candidates for the potential treatment of cancer, eye diseases, and inflammatory diseases and has preclinical programs in other diseases and disorders. Additional information about Regeneron and recent news releases are available on Regeneron's worldwide web site at www.regeneron.com.
Forward Looking Statement
This news release discusses historical information and includes forward-looking statements about Regeneron and its products, programs, finances, and business, all of which involve a number of risks and uncertainties, such as risks associated with preclinical and clinical development of our drug candidates, determinations by regulatory and administrative governmental authorities which may delay or restrict our ability to continue to develop or commercialize our drug candidates, competing drugs that are superior to our product candidates, unanticipated expenses, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any collaboration agreement, including our agreements with the sanofi-aventis Group and Bayer HealthCare, to be canceled or to terminate without any product success, risks associated with third party intellectual property, and other material risks. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission (SEC), including its Form 10-Q for the quarter ended March 31, 2007. Regeneron does not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise unless required by law.
Contact:
Regeneron Pharmaceuticals, Inc.
Charles Poole, 914-345-7640
Investor Relations
charles.poole@regeneron.com
or
Laura Lindsay, 914-345-7678
Corporate Communications
laura.lindsay@regeneron.com
or
Lauren Tortorete, 212-845-5609
Media Relations
ltortorete@biosector2.com
--------------------------------------------------------------------------------
Source: Regeneron Pharmaceuticals, Inc.
http://www.regeneron.com/company/press_detail.asp?v_c_id=274
REGN- thanks P-life. I bought a bunch more REGN yesterday and think it will do well over the upcoming year (stock and data from clinicals).
CAMH -
Thanks for the reminder Geoff. Will have to give CAMH consideration! fyi, I've been buying more REGN today after the extreme fallout from their recent highs. The fundamentals and cash postion strongly support value here in the low $18's imho.
I'll patent sugar, at least it won't kill anybody.
LOL. It will kill us diabetics if mass quantities! ;)
Thanks Biowatch. I'll have to see what these new insulin pens look like and what their pricing would be for full term use for myself. I've been using the old insulin vial and syringe standard for 20 years, and pre-draw any shots I may need for the day and carry them with my blood glucose test kit. The one advantage of the i-Pen in my mind is that I won't look so obvious if I need to give myself a shot in a public place. I actually reuse my syringes a few times which saves me a little money, and more so my insurer. Do these pens have an insulin resovoir in them? 15 ml?
I'm just curious though about the risks if a child happened to get into ones supplies and i-Pens. I would hope they have a locking device on the i-Pens??
Thanks for your post!
Yes, coffee makes life more enjoyable -- at least its my morning exlixar! And I started drinking it black, without any milk, after reading an article posted here how milk binds out the antioxidants. Wasn't too bad switching to black. Once you get use to if a few times it becomes nectar. Cheers for black coffee, red wine and dark chocolate. Three of my antioxidant food groups I have each day. ;)
Spartex
OT: POZN - thanks. No, don't follow it, but will check it out. What is your entry price point? Like RPRX, it is always best to get in a subground levels ($6-9's). Are these guys sort of like the former KOSP (did combos of drugs generically).
Thanks!
Bio_Pete, they will eventually show up.
It is nice to see that someone is still picking RPRX up......slowly and surely, one 10k block at a time.
http://finance.yahoo.com/q/bc?s=RPRX&t=1d
OT: bought more GNVC today after the sell off. Missed the lows of yesterday. Watching REGN for additional accumulation in the 18-19 range. Very attractive imho.
Thanks Pete. Yes, no sellers, and now buyers are having to anti up a higher bid! ;) 52-week closing high today??
Pete, are you seeing block buys?? Big volume coming through now on RPRX. thanks!
Nerf, great news in that Androxal was stat. sig compared to Androgel at 6 mo treatment for test levels. I guess I shouldn't be surprised that the QoL's didn't hit stat. sig compared to placebo, as this is a subjective metric.
Repros’ Androxal Shows Highly Statistically Significant Positive Effects in Men with Secondary Hypogonadism
Non-Inferiority to Market Leading Drug
Demonstrated in Six Month Study
THE WOODLANDS, Texas--(BUSINESS WIRE)--Repros Therapeutics Inc. (NasdaqGM:RPRX) announced topline results of a six month U.S. Phase 3 study of Androxal™, an oral drug being developed to restore normal testicular function in men with secondary hypogonadism. Further, Androxal demonstrates non-inferiority in all the endpoints of the study, compared to Androgel®, a cream which is the leading treatment for low testosterone.
Study Details and Results
This six month, double-blind study compared two doses of oral Androxal, 12.5mg and 25mg, to matching placebo capsules and open label Androgel at any dose to be used per manufacturer's instructions. The study's primary efficacy endpoint was the proportion of patients at month three who showed morning total serum testosterone concentrations within the normal physiological range (300 to 1040 ng/dl). This endpoint was also extended to include the outcome at month six as well as the assessment of non-inferiority to Androgel.
Of the 191 patients enrolled in the trial, 144 patients completed the study. There were 8 and 15 premature drop outs in the 12.5mg and 25mg Androxal arms, respectively, 15 drop outs in the placebo arm, and 13 drop outs in the Androgel arm. There were no drop outs due to an adverse event or lack of compliance in the Androxal treatment groups. The majority of the other drop outs were due to either withdrawal of consent or "lost to follow-up". There were 188 patients in the modified intent-to-treat group (“MITT”) consisting of all randomized patients with at least one efficacy evaluation.
The proportion of men in the 12.5mg and 25mg treatment arms with total testosterone in the physiological range at month three using the last observation carried forward was 72.7% and 79.2%, respectively, and those on Androgel and placebo the proportion was 57.4% and 28.3%, respectively. These results confirm non-inferiority to Androgel (measurements for patients that completed month three equally demonstrated non-inferiority). Both doses of Androxal were superior to placebo (p <0.0001). At month three, the mean improvement in testosterone levels was 184.3 and 259.2 ng/dl for both the 12.5mg and 25mg dose of Androxal, respectively. The improvement for Androgel and placebo were 168.3 and 6.4 ng/dl, respectively. The 25mg dose of Androxal achieved a statistically significant improvement compared to Androgel (p = 0.036). The improvement in total testosterone level was maintained for the entire six month double blind period and the proportions of subjects achieving testosterone levels greater than 300 ng/dl were 70.5%, 84%, 53.2% and 31.9% for 12.5mg, 25mg, Androgel and placebo arms, respectively.
The improvement in total testosterone in the Androxal arms was the result of normalization of the pituitary gonadotrophic hormones LH (luteinizing hormone) and FSH (follicle stimulating hormone). Consistent with the diagnosis of secondary hypogonadism, LH values at entry were in the low normal range with a median value of 3.7 mIU/mL. After three months of treatment LH increased to normal values of 5.8 and 8.1 in the Androxal 12.5mg and 25mg groups, respectively, remained unchanged at 3.3 in the placebo group but decreased significantly to 0.3 in the Androgel group, a value below the normal range. After six months of treatment the values for the four treatment groups were similar to the values at three months. The trends for FSH increasing from low to normal values in the Androxal treatment groups were similar to the LH responses. FSH decreased statistically significantly (p <0.0001) in the Androgel group and remained unchanged in the placebo patients. The sex hormone responses to Androxal treatment are consistent with normalizing pituitary function.
Jean Fourcroy, MD, PhD, Repros Therapeutics Board member and former Medical Officer with the Food and Drug Administration, commented, “This study points out the importance of considering secondary hypogonadism, or hypothalamic dysfunction, when diagnosing hypogonadism in men.”
Although the syndrome of secondary hypogonadism is characterized by the objective measurements of low testosterone and gonadotrophic hormone levels it is recognized that in some men testosterone deficiency may be accompanied by a variety of symptoms related to decreased sexual function. This study did not require that any of those symptoms be present at enrollment as the primary inclusion criterion was low testosterone and low to normal LH. Nonetheless, as an exploratory exercise, three different patient questionnaires were included in the study to explore the relationship of these symptoms to low testosterone and the effects on these symptoms exhibited by increasing testosterone. The questionnaires that the subjects completed at monthly intervals were the “International Index of Erectile Dysfunction”, “Sexual Desire Survey form, DISF-SR II” and the “Male Sexual Distress Scale” developed by Len Derogatis, PhD, Director, Center for Sexual Medicine at Sheppard Pratt Health Systems in Baltimore. Analysis of the MITT subjects indicate that in none of the symptom domains was there a difference in response from placebo although many of the treatment groups improved in comparison to baseline values. Although neither men treated with Androxal nor those treated with Androgel reported a significant increase in libido as determined using the DISF-SRII, both doses of Androxal performed comparably to Androgel. Likewise, although no statistically significant differences in distress, as measured by the MSDS scale, were recorded for men receiving Androxal or Androgel, both doses of Androxal performed in similar fashion to Androgel. Numerically, the 25mg dose of Androxal produced the greatest reduction in distress followed by the 12.5mg dose.
Overall the safety of Androxal was very similar to that of Androgel and placebo. The number of subjects with at least one adverse event was similar in all four treatment groups. These events were mostly mild to moderate and occurred at a very low overall frequency. The occurrence of serious adverse events was one in the Androxal 12.5mg, none in the 25mg, two in the Androgel and one in the placebo group. Apart from a tendency to reduction in cholesterol and low density cholesterol in both Androxal groups there were no clinically important changes in other laboratory values. The reductions in cholesterol and LDL cholesterol were less consistent in the Androgel treated subjects. Hemoglobin tended to increase more in the subjects receiving Androgel.
“We are very pleased that these results confirm our interim analysis data,” commented Joseph Podolski, President and CEO of Repros. “This study demonstrates that the use of Androxal, a once daily oral capsule for the treatment of secondary hypogonadism, is a rational approach as pituitary function is normalized and the subjects benefit from a normal testosterone production and are not subjected to the suppressive effects of exogenous testosterone replacement. Androxal has the potential to change the way in which secondary hypogonadism is treated in the future.”
Repros anticipates reviewing these findings with the U.S. Food and Drug Administration later this summer to determine the remaining clinical path that must be navigated before submitting a New Drug Application.
About Repros Therapeutics Inc.
Repros is engaged in the development of pharmaceutical products that address conditions of the male and female reproductive systems. Proellex™, the Company’s lead compound, a PRM (progesterone receptor modulator), has recently completed a successful three month U.S. Phase 2 clinical trial for the treatment of uterine fibroids, a condition that affects numerous women of childbearing age in the U.S. and results in a significant number of hysterectomies each year. Proellex is also being studied in a six month European Phase 1/2 study for the treatment of endometriosis, a condition that affects approximately 5.5 million women in the U.S. and Canada. Androxal, the Company’s other program in late clinical development, is designed to restore normal testosterone production by the testes and has completed a six month U.S. Phase 3 clinical trial for the treatment of testosterone deficiency in men due to secondary hypogonadism. According to industry sources, approximately 13 million men in the United States experience testosterone deficiency.
For more information, please visit the Company's website at http://www.reprosrx.com.
Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Repros’ ability to have success in the clinical development of its technologies, the timing of enrollment in such clinical studies and the accuracy of such studies, Repros’ ability to raise additional capital on acceptable terms or at all, and such other risks which are identified in the Company's Annual Report on Form 10-K for the year ended December 31, 2006, and Repros’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2007, as they may be updated by the Company’s Exchange Act filings from time to time. These documents are available on request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
http://home.businesswire.com/portal/site/repros/
two news items coming by the end of june, I guess
Well, I thought JP would be able to wrap up the endo results by end of May, but it looks like he was being too optimistic since it is a trial overseas, and they use a contractor to analyze the results.
I would hope we'd get some reports later this week or next week.
I get to sleep tonight with another $300 bucks under my pillow.
You mean you sold your 1000 shares bought at 13.75, at 14.05?
You don't have the $300 bucks under your pillow until you pull the trigger. Nonetheless, I'm sitting on some very large paper gains in RPRX at the moment.
OT: AIS BioPete, I agree! I did buy a small position on Friday in the $2 region. Would have loved it better at 1.7's. Can't win them all.
I would like to buy some JAV if it retreats to the low $6's. I had the opportunity to buy in the 4.5-5 region, but I only have so much $$$ to go around. I'm stocked to the gills with RPRX, so I would like to see it continue with its upward trend and positive news.
However last news items have left the stock price unfazed
I don't know about you, but having the stock go from $10.5 to $14 after uterine fibroids news isn't what I'd call "unfazed" stock movement. >30% in just the past two months makes me very happy.
OT: NCAA Softball Championship
I've been watching it the past few hours. My wife's alma mater Texas A&M is now getting spanked by sister Texas school Baylor. These women can also hit the ball incredibly hard too - one Baylor woman tagged a HR at around 220+ feet; a few of the smaller women are actually the bigger hitters!
I agree, but if he appeals the likely outcome may be another slaughtered DNDN lamb. Will an appeal tarnish their already established relationship with the FDA? Or maybe that went out the window with the approvable letter? It's a doubled-edged decision, and Mitch must certainly understand the political environment he faces with such a decision. I understand the value in standing up for the company's science and patients in need of a Provenge therapy, but the question is whether this is a battle worth fighting at this time?
Bio_Pete, did you mean QoL's for Androxal, not Proellex in your Q to io_io? Guess the share move of RPRX is getting you excited today! ;)
Hi Crou - I think you should thank that guy TDH on the IV DNDN board. He as pounding the table on RPRX in the $6's and a bunch of guys there were telling him to get lost. Guess he got lost with his $$$$$$ heee. heee.
io_io - thanks for your brief update. I don't remember Nerf giving an update on the Uterine Fibroids histologies report. I'm wondering if August was the original date for that report. Nerf still said that the safety report for Proellex will be in late June. Is this a different report that UF histology? Nerf or anyone else??
Nerf's previous report.
http://www.investorshub.com/boards/read_msg.asp?message_id=19094621
Ok, here's $14. Nice move today!
OT: Nettles Says Wild Card Makes Yankees Comeback Easier Than 1978
By Danielle Sessa
June 1 (Bloomberg) -- Graig Nettles, who helped the 1978 New York Yankees erase a 14-game deficit to catch the Boston Red Sox, said this year's team has an easier road to a championship.
The 2007 Yankees trail the Red Sox by 13 1/2 games heading into their series at Fenway Park in Boston this weekend. They can make the playoffs as a wild card without winning the division -- a luxury Nettles's team didn't have.
``They need to realize they have four months to make it up, and not to panic,'' Nettles, 62, said while signing autographs for fans during a promotion at Bryant Park in Manhattan. ``There is always the wild card. We never had that pleasure.''
The 1978 Yankees came back to finish in a tie with the Red Sox for the American League East title. In a one-game playoff at Fenway, Bucky Dent hit a three-run homer in the seventh inning to give New York the lead in a 5-4 victory. The Yankees went on to win the American League Championship Series and beat the Los Angeles Dodgers in the World Series.
Back then, the American and National leagues were split into two divisions each, and only the first-place teams made the postseason. Now, three division champions make the playoffs in each league. Each also has a so-called wild-card berth, which goes to the second-place team with the best record.
Record Comeback
This year's Yankees need a record comeback to win the division. New York was 14 1/2 games behind on May 30, and no team has rebounded from more than 14 games back to win a division since Major League Baseball adopted a divisional format in 1969, according to Elias Sports Bureau Inc., the sport's official statistician.
The Yankees are seven games behind the Detroit Tigers for the wild card, and there are six clubs closer to the Tigers than New York. Both the 2003 Florida Marlins and 2005 Houston Astros rallied from 11 1/2 games behind in May to earn the wild card. The Yankees have been as much as 8 1/2 games back in the race and would need the fifth-biggest comeback to win it, Elias said.
The 1995 Yankees rebounded from nine games behind to win the wild card, the fourth-biggest comeback since its inception in 1994.
``Everybody is counting the Yankees out already, but I've seen too much happen in this game,'' Rich Gossage, who pitched for the 1978 team and played for 22 seasons, said in an interview.
From the start of the 1978 season to the July All-Star Game, the Yankees went 46-38 while the Red Sox went 57-26, according to Stats LLC, the Morton Grove, Illinois-based company that collects and sells sports statistics. Their fortunes reversed after the break: New York went 53-25 and Boston went 42-37.
``You can't get too down when you are going poorly,'' said Gossage, 55. ``You can't get too high like the Red Sox -- they can't get too jolly this early because there is a long way to go.''
Pitchers' Injuries
The Yankees' slow start came with a series of injuries to starting pitchers, including Chien-Ming Wang, Mike Mussina and Carl Pavano.
New York's offense has also struggled. Center fielder Johnny Damon and designated hitter Jason Giambi are batting at least 25 points below their career averages. The Yankees learned yesterday that Giambi will miss three weeks or more with a foot injury. Right fielder Bobby Abreu, a career .300 hitter, is at .228 and has been dropped from third to seventh in the lineup.
The Red Sox have won seven of their past 10 games and swept the Yankees in their first series at Fenway.
In tonight's game, Wang (3-4) pitches against Boston's Tim Wakefield (5-5). Tomorrow it's Mussina (2-3) against Curt Schilling (5-2), and Andy Pettitte (3-4) is scheduled to face Josh Beckett (8-0) in the series finale.
New York doesn't play Boston again until a three-game series at Yankee Stadium Aug. 28-30. They play their final three games against each other Sept. 14-16 at Fenway.
``I don't think the race is over yet,'' Gossage said. ``There is too much baseball to be played.''
To contact the reporter on this story: Danielle Sessa in New York at dsessa@bloomberg.net
Last Updated: June 1, 2007 02:55 EDT
http://www.bloomberg.com/apps/news?pid=20601079&sid=ad3oz4nHTFYE&refer=home
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don't let the door hit you on the rear on your way out! LOL
Dew, yes good calls by you regarding your predictions!
The only thing that most people who were bearish (or neutral) on DNDN didn't expect was the stock to be trading at 50% premium to the pre-panel meeting after a follow-up "approvable" letter by the FDA. Even I, being bullish on the cassette immunotherapy concept, but cautious in my expectations of DNDN's chances w/ FDA, didn't expect the stock to be much higher than $5 initially. However, I believe there are a number of positive things going on behind the scenes (discussed on the conf call) than just the anticipated update on 9902b trial enrollment being complete/announced, and then interim data release by DNDN next year. I see downside of around $4-5 bucks if DNDN misses their "supportive interim" update w/ FDA, while upside of $18++ if they provide what the FDA needs for approval. I like this bet, especially since my current avg. position is in the low $5's. I can wait it out without much worry.