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Wednesday, November 16, 2011

News & Notes: Penn State, Herman Cain, Jose Reyes And More...

You've got to laugh at the market hype created by the media, and the panic created by the fickle-minded investors who all contributed to last week's significant volatility that saw a near four hundred point drop by the DOW immediately followed by a gain of over two hundred points. 

One day the headlines read that the failing economic hopes of Italy and Greece are going to lead us to doomsday, but the next day all is forgotten and the headlines read that stocks are rising because fears have been "allayed"?

Overnight?  Don't think so.

Let's just face it, it's a volatile era.  The news media is just pulling stories from, well you know where, in covering the volatility.  There's still opportunities for some nice buy and holds - InVivo (OTC BB:  NVIV) might be one of those, but the traders can make a payday out of playing the short term ups and downs in the market as a whole.

Speaking of Italy, confidence might be reinstalled in the global markets knowing that Silvio Berlusconi is finally giving it up after years of alleged sexual misconduct.  The thought that more attention will now be paid to the country's finances than to weekend bung-bunga parties is sure to quell some investor nerves; and good ol' Silvio can now turn all of his attention to the bunga-bunga full time.  Maybe even invite Kim Kardashian, since she's free for another sham weekend now.

In politics, Republican Presidential candidate Herman Cain has been facing a rash of attacks for alleged sexual misconduct during his tenure as the president of the National Restaurant Association.  The women have been coming out of the woodworks, although only one named, to slander the presidential hopeful, and to no surprise the celebrity lawyer Gloria Allred is leading the charge. 

That said, Allred is also responsible, in my opinion, for a large portion of the public not taking these allegations seriously.  In a recent news conference, Allred stated that what Mr. Cain did to her client was "try to give her a stimulus package of his own." 

Pretty funny and opportune joke, but how is anyone else going to take the allegation seriously if Ms. Allred herself is making jokes of it?

In sports, with Jose Reyes all but gone, and with the New York Post reporting that David Wright is on the trading block, there's no reason for Mets fans to stick to their team next year.  It's quite a shame, and maybe with the spare time of not having a team to follow, we need to 'Occupy Citi' until the Wilpons get lost; of course we don't want to occupy the seats, because that puts our money in the Wilpons' pockets, but we can do like the 'Occupy Wall Street' folks when they were on the Brooklyn Bridge - we'll 'Occupy Citi' from Yankee Stadium - or we can head down 95 and watch Davey and the 'Nats.

And lastly, JoePa, say it ain't so. 

After all the tough talk from the Penn State Board of Trustees last week, when they collectively fired the long time legendary coach Joe Paterno and the Penn State President, you have to wonder if the Board of Trustees needs to relieve themselves as duty as well - it looks to me like they're the ones with the real power around there; if it's a change of direction and image they want, then the board should step down, too.

Saturday, October 29, 2011

The Search For A Cure For Paralysis

A couple of years ago shares of Geron Corporation (GERN) spiked to a near billion dollar market cap - an impressive feat for a company with nothing past Phase II trials at the time - on hype created by its embryonic stem cell treatment for spinal cord injuries (SCI) circulated the investing circuits.  The trial was the first-ever approved by the FDA utilizing embryonic stem cells, and its initiation ushered in a new wave of hope for the millions around the globe suffering from the effects of severe spinal cord injuries, including hundreds of thousands in the United States alone.

Another wave of hope for SCI patients hit the wires in early October, when Doctors announced a new technology that could have just as easily been born in a scene in a Bruce Willis Sci-Fi movie.  This technology allowed monkeys to use their brains to move the virtual hands of an avatar, a breakthrough that was hyped to become a huge benefit for those suffering with paralysis resulting from severe SCI.  This technology also allowed subjects to 'virtually' feel the texture of the objects they were touching through an outside robotic exoskeleton.

While the above events created significant buzz, Geron's treatments are still many years away from market and the sci-fi adventures described with the robotic exoskeleton left lingering questions as to whether medicine will ever advance enough to allow the paralyzed to walk, touch and fell on their own again, never mind an avatar that does it for them.

A solution might not be as far away as we thought, judging by results from preclinical studies in monkeys by a small, emerging company with answers.

Preclinical studies of a technology developed by InVivo Therapeutics (OTCBB:  NVIV) have allowed paralyzed rats and monkeys to walk again, within weeks of initial treatment, and the company is just awaiting the green light from the FDA to begin its first trial in humans.

The preclinical results, already published in the Journal of Neuroscience Methods in 2010, marked the first time that paralyzed monkeys were able to walk again following treatment for paralysis and were convincing enough to allow InVivo to land a high profile defection from Geron in early October when Edward Wirth, M.D., Ph.D. was named NVIV's new Chief Science Officer (CSO).

Dr. Wirth, a renowned leader in the field of regenerative medicine, led Geron's spinal treatment initiative and will join InVivo in early December and will lead the human trials that will be necessary for an eventual FDA approval.  With the technology and data from the preclinical trials already before the FDA, and with the manufacturing, science and materials already in place, the company is just awaiting the regulatory green light to move forward with the human phase.

So what is this novel technology that has has invigorated hope in the SCI-treating community landed the company's co-founder, Robert Langer, ScD, on the short list of candidates for the Nobel Prize in medicine for 2011?

It all starts with InVivo's biopolymer scaffold device (BSD) that has, in early studies, demonstrated a therapeutic effect in healing the spinal cord.  While most other companies relevant to the the field are developing treatments and methods with a pharmaceutical basis, InVivo's BSD is being developed as a medical device and addresses the serious threat of secondary injuries to the spinal cord that generally lead to the most severe cases of SCI and paralysis.

The scaffold, as described by company founder and former paralysis patient himself Frank Reynolds, can be customized to fit each spinal injury and can be administered right there in the operating room when an SCI patient first arrives into the ER.  Ninety percent of SCI patients are not initially paralyzed, rather they only suffer from spinal shock, only to become paralyzed by secondary injuries caused by inflammation, bleeding and scarring.  Again, InVivo's BSD looks to heal the spinal cord in a timely manner before those secondary injuries take effect.  The BSD is convenient enough to be administered in conjunction with the current standard of care, which consists of installing rods and screws in and around the damaged area of the spine, and wards off those devastating secondary injuries by allowing the spine to heal itself quickly.

If the secondary injuries can be warded off, the theory holds, then so can paralysis.   

In support of that theory, 100% of the monkeys treated with InVivo's scaffold in preclinical studies were up and running within 12 weeks.  The mood is encouraging that move to human trials from non-human primates will prove successful, given the similarities in anatomy and bodily structure between the monkeys used in the preclinical studies and humans; it's the shift from rats to monkey that was the larger technological leap.

With that said, should the human trials turn out positive, then the path to approval could be fairly quick since the scaffold is being developed as a medical device and not as a new drug.  Medical devices are generally approved in a more expedient manner than new drugs by the FDA, so even with the human trials still yet to commence for InVivo, it's possible that the BSD can be on the market literally years before Geron's regenerative embryonic cell treatment. 

This, however, brings up an interesting transitional point; the potential is there that treatments such as Geron's will be best administered utilizing InVivo's scaffolding technology.  That makes InVivo's growing patent portfolio that much more valuable.

In addition to treatment with the scaffold alone, InVivo has already tested its device in combination with drugs and/or cells, although not yet in human trials.  The company plans to continue that testing line and eventually file for approval of its scaffold in combination with the combination therapies.  As outlined in this video clip, the company has thus far been very successful with the combination applications as well as with the scaffold alone, and an injectable, gel-based scaffold is also being pushed through the developmental phases.  In fact, it's treatment with the said hydrogel that Mr. Reynolds says produced the best results in the completed monkey studies, according to the above-linked clip.

Once InVivo has secured FDA approval for the scaffold as a medical device, additional approvals for the combination therapies will also be sought after.  Assuming the products or treatments that will be combined with the BSD are already FDA approved, then the path for the combination approvals should also come relatively quickly.

The vast treasure chest of worldwide patents compiled by InVivo is still growing, protecting its technology well into the future and opening the door for licensing and partnership revenue, as I alluded to previously in discussion with Geron's experimental treatment.

Additionally, the BSD is also being discussed to treat indications other than just SCI, opening the door to other highly-lucrative markets.

The possibilities presented by combining InVivo's scaffold with other drug and cell therapies has already led to a strategic partnership with the Miami Project, an organization that has to date raised nearly half a billion dollars in search of a cure for SCI-induced paralysis. This collaboration will study InVivo’s tissue engineering technology in conjunction with the Miami Project’s Schwann cells and was featured last month at the Buoniconti Fund to Cure Paralysis 26th Annual Great Sports Legends Dinner fundraising event.

In commenting on the Miami Project collaboration, CEO Frank Reynolds noted, “We look forward to the results of our preclinical work with the Miami Project, and are hopeful that the combination of the scaffold and Schwann cells will improve the therapeutic effect of both technologies.  Our scaffold has shown excellent results in non-human primates and in a rodent contusion model treating paralysis following acute spinal cord injury. We remain on target to begin a 10-patient pilot study in acute spinal cord injury in 2012.”

With human trials on slate, and with stellar preclinical results, the makings of a paradigm shift in the treatment of SCI could be underway.

Stay tuned.

Disclosure:  Long NVIV.


Sunday, July 3, 2011

News & Notes for the Week: Transformers 3, Dominique Strauss-Kahn, Casey Anthony and more....

We can all finally be rid of the Casey Anthony madness - verdict should be out soon enough and the television news networks can get back to reporting news (tongue in cheek statement) instead of parading garbage in front of us every day.

Looks like Dominique Strauss-Kahn might be off the "hook". Reports out of New York indicate that the alleged victim in the rape case was actually hooking in her spare time for some extra cash.

Even before that bombshell development, her credibility was taking hit after hit, and ended up looking like a Mike Tyson opponent of the late eighties/early nineties.

It's about as certain as can be that all charges against Strauss-Kahn will be dropped, as he was undoubtedly duped - as was just about the entire nation - by a two bit hooker looking for some extra cash.

Twenty-eight hours after the alleged sexual assault, the woman talked to her boyfriend in an immigration jail in Arizona -- saying "words to the effect of, 'Don't worry, this guy has a lot of money. I know what I'm doing,' " The New York Times quoted an official saying.
The news is brilliant for the likes of Dominique, who will easily be able to rebuild any lost rep, and will look as invincible as ever, but what's up with wife being all smiles as they walk hand in hand out of the courthouse the other day?

Maybe he didn't just take what he wanted, as was originally alleged, but the fact is that he was still skanking around in that hotel room - that's nothing for wifey to be smiling about.

Not like you have the poster-child family man here.

Not sure what to make of 'Transformers 3: Dark Of The Moon' just yet. I can't help but feel like they tried to do too much this time. The first half of the movie was spent waiting for something to happen, then when it did, it was sensory overload.

Decepticon spaceships? Where'd they come from? Just a few days before the attack on Chicago the Decepticons were supposedly spread far and thin around the globe to hide from energon detectors, but they managed to build spaceships the size of Manhattan without anyone noticing?

The quirky characters and dialogue of the first two movies was just right, but in this go-round too much time was spent on building those quirky dialogues, and not enough time was spent on the Transformers that people went to the movie to see. You never even got to know who the new Autobots were, like you knew Bumble Bee, Iron Hide and Ratchet after the first.

Did anyone really go to the theaters to see Sam look for a job? Weak plotline that killed the pace of the movie.

This one was a bit darker, too. Kinda like 'Spider-Man 3' went dark for the the third installation.

Iron Hide getting whacked by Sentinel Prime?

Bumble Bee about to be executed without giving up so much as a fight?

Come on now.

On the flip side, the action was there in full (3-D) effect when it finally materialized. And Shock Wave was awsome - the epitome of Decepticon mayhem, what Megatron should have been if you saw him at all in the movie.

A little was lost with Megan Fox not being around. The Victoria Secret model that took her place was very easy on the eyes, but it's hard to ask the audience to buy into a new love interest in part three and have an emotional attachment. They might have been better off just leaving out the sappy stuff and sticking to the action.

I'll give this one another go before deciding what I think, but the pace was a bit too choppy (stagnant for long periods of the film) to call it epic - as this one should have been.

Mets fans are all holding their breath waiting to see the results of Jose Reyes' latest hamstring injury. It was about this time last year when the Mets fell completely off the map, and take Reyes out of that lineup, and this season is done. Finito. Kaput.

So is all that money that Jose had coming to him. If this injury - or anyone to his hamstrings - has him missing more than a few games, then he's taking about 30% less than what he would have made on the free agent market. That could bode well for the Mets in negotiations, but Jose might be wishing he started negotiating in-season.

A couple of weeks on the shelf will have Jose signing a one or two year deal so that teams can see him prove that he do it all again without getting hurt. Any longer and Jose will actually not get much interest outside of New York City. No team outside of the Mets, Yanks and BoSox will pay Jose Reyes-like money to a guy who is a perpetual injury risk.

Klitschkto on points? Weak. They could have fixed this one a little better than that.

The ladies final at Wimbledon was a much better watch.

And Muammar Khadaffi still out there sticking his thumb up at the world - you wonder what could have been if the international community didn't look like bumbling fools in the early stages of action against Khadaffi's forces. Give him time to hunker down and guess what - the guy hunkers down and you can't understand why he won't give up.

Saturday, June 25, 2011

Weekly News & Notes: Why Politicians Do What They Do, Same-Sex Marriage, Legalizing Marijuana, Sean Penn, Weiner, and The Mets

Regardless of where you fall out on the issue, New York State's approval of same-sex marriage puts the issue on the map, big time. 

This goes down right at the same time that Representative Barney Frank from Massachusetts is all over the place hyping the deregulation of marijuana.

Funny how the politicians finally start making these long-on-the-backburner decisions when their states are heading towards bankruptcy and new revenue streams are needed.  The taxation on marijuana sales could significantly boost state coffers, as booze does, while New York could do very well with the granting of these marriages; the lack of a residency requirement for getting married in NY means that the place is destined to become a hot location for out-of-towners looking to officially seal the deal.

I know we like to believe that politicians make decisions for the right reasons, but let's face it - it's all about money and winning elections.

Take House Majority Leader Eric Cantor (R-Va.) and Sen. Jon Kyl (R-Ariz.), for example, both of whom walked out of bipartisan budget negotiations because they weren't getting their way.  With the national debt ceiling about to be breached in August if it's not lifted, this is a hot issue that needs resolution - but you can't get that resolution if these over-payed politicians are taking their balls and going home.

Like I said about the politicians who left Wisconsin rather than face the tough issues, if you're not going to work, then don't take the paycheck.

Rumor has it that this is all grandstanding to get Mr. President more directly involved so that he might say something that Republicans can use against him in the campaign season, which brings us back to my original point - the politicians don't do anything for the good of the people, it's all about winning elections.

The ironic thing is, if you made decisions based on the good of the people, the people might be more inclined to vote you in again, making all these headline-making shenanigans unnecessary.

One politician who's done worrying about getting voted in, the former New York representative Anthony Weiner, might have a job future sooner than you think.  Although MTV is denying the reports, rumor has it that the 'Jersey Shore' is going be re-cast. 

It's quite obvious that Weiner was auditioning for the part of The Situation, so maybe he'll get the call.  If not, he's destined to a life of making YouTube videos.

On the international front, Sean Penn's good buddy Hugo Chavez made some headlines this weekend when - after two weeks of silence - sent out a few 'Tweets' to let his subjects know that he's still alive, kicking, and well in charge.  I'm sure the people of Venezuela are glad to know that Chavez will be back to claiming all private enterprise as part of his own personal empire before too long.

Maybe Sean Penn has been his sit-in down there while Hugo convalesces in Cuba; haven't heard anything from him since his fling with Scarlett Johansson (what was she thinking?).

Haven't heard yet that Penn is willing to grant Muammar Khaddafi asylum and put him up in his own mansion since the mad dictator is now rumored to be looking to jet from Tripoli, but expect to hear something soon.

Some of Penn's other personal heroes - those in the Chinese government - have been making some noise in the headlines as well.  As the citizenry grows increasingly malcontent about the inhuman working conditions in the country, the government is said to be taking a harder line (if that's possible) against anyone who falling 'out of line'.  Bloggers, reporters, everyday Joes - they're all reportedly being thrown in the slammer over there these days. 

Meanwhile, in the factories and the fields, the people are working 16 hour days for a couple of dimes to make sure you get your sneakers on time.

It's getting awfully hard for Washington to justify all that financial aid to Pakistan.

The New York tabloids have been speculating for some time now as to where Jose Reyes and K-Rod will end up, whether it be next season or at the trading deadline.

K-Rod is a sure-bet to be gone by the end of July, while Reyes might finish the season out before playing the field in the free agent market.

What kills Mets fans, however is that both of these guys are a great fit for the Yankees.

The Yanks are denying any interest in K-Rod, but with Soriano on the shelf, and Mariano not getting any younger, K-Rod would look pretty decent in the Yankee 'pen.  The Mets wouldn't hesitate, in my opinion, to throw Fransisco across-town, but Reyes is another story.

It would be hard to recover from the PR hit the Mets would take by letting Reyes don the Yankee pinstripes, but it's a possibility that needs to be entertained.  As much as Yankee fans won't admit it, it's time to start looking past Jeter at short.  Reyes is a high-profile player, and would love to play in the Yankee spotlight, and might love even more to shove it to the Mets and Wilpon after the disrespect with which Wilpon showered his players earlier this year.

Wilpon said, at the time, that Reyes was looking for a big-monied contract that he's just not worth, or going to get.  When Wilpon said that, it all but ensured that the only way Reyes comes back to Citi is for a big-monied contract, that he probably won't be worth.

The only ones who might show up in the same price range, is the Yankees, and that would be a coup that ensured the Mets remain second fiddle in NY baseball for probably another decade.

And while we're on the subject, Carlos Beltran is a nice fit at DH for the Yanks, as well. 

Thanks Freddy Wilpon, for chasing your best player away and building a ballpark where careers like Jason Bay's go to die.

The way this guy has ran the ballclub and his personal wealth into the ground, he's worthy of a spot in Washington alongside the politicians.  This way, at least he could run the country into the ground, but build his own personal wealth by playing the lobbies and expense accounts the right way.

At least we can vote the politicians out, Mets fans are stuck with Wilpon.
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