Dr. Horacio Kaufmann to Present Findings From Droxidopa Study 302

Company to Host Conference Call at 4:30 PM EST

Former FDA Branch Chief to Assume New Position as Head of Chelsea's Medical and Regulatory Affairs

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First the question about Chelsea Therapeutics International Ltd. (NASDAQ:CHTP):

I was wondering if your thoughts have changed on CHTP since they were @ $7+.

Thanks,Noah

My Take: CHTP was trading for over six dollars when I first commented on the stock, and at that price I wasn't much of a fan.

Since that time, the company's lead drug Droxidopa failed to meet the endpoint of a Phase III trial designed to measure the drug's effectiveness in treating symptomatic neurogenic orthostatic hypotension (NOH). However, with an additional Droxidopa trial still ongoing and with the stock now trading for about $2.25, CHTP is being considered by some as a potential rebound play.

In my opinion, I still think that there are better - and safer - rebound plays out there than this one, although the possibilities are there for CHTP to eventually recover.

{tiny;CHTP;1}Chelsea has pending talks with the FDA where they may attempt to alter the trial design of the second ongoing trial, since it has been claimed that it was a poorly designed endpoint that caused Droxipa to fail the recently announced trial. That being said, the short to mid term success of this company depends on the FDA 'playing nice' with a company after a failed trial. That's something that doesn't happen too often and I'm not willing to risk my money on that proposition.

At the current time I'd enter into an investment in CHTP with the assumption that the ongoing trial will continue on unchanged, meaning that I'd be worried - as an investor - that the results of this trial could be met with the same results of the failed one. That's a little bit more risk than I'd like to take on, even while the stock is trading for just over $2.

By comparison, I like the prospects of Titan Pharmaceuticals, Inc.(OTC:TTNP)- although Titan has started to rise pretty significantly lately- and BioDelivery Sciences International, Inc.(NASDAQ:BDSI) more than CHTP because both stocks are set to start raking in revenues on already approved drugs and are still trading at levels that I believe do not believe justify their market potential over the next few quarters.

I do see a possible upside for CHTP if things go right with the ongoing trial and/or if the FDA allows the company some flexibility with the still ongoing trial, but realistically I think that a recovery to previously traded levels may be a couple of years off at this point.

Of course, that's just my opinion.

Hi Vinny,

I am a loyal follower and respect your opinion. I wanted your opinion on two companies, of which I am already a shareholder, Lexicon Pharmaceuticals (NASDAQ:LXRX) and Rexahn Pharmaceuticals (AMEX:RNN). They have a strong and diverse pipeline, along with good management and partnerships. The companies are low-key, meaning that no bloggers have put them in the spotlight (although sometimes the spotlight isn't necessarily a good thing) and wanted your opinion.

Thanks,

Marcel

My Take: Let's talk about Lexicon Pharmaceuticals, which currently trades with a market cap of over 250 million.

What I like about the company and its stock is that there are multiple 'small molecule' drug candidates in the pipeline - all treating different indications with decent sized market potential - so if one or two were to fail any of the ongoing trials, then the company has additional product candidates to fall back on.

{tiny;LXRX;1}I also like the fact that the four lead product candidates are in relatively the same spot in Phase II trials because news and updates could come in bunches, which could lead to fairly extreme volatility in the stock price. Another positive for the company is the fact that they have existing partnerships with some big time pharma players. Any drugs or products developed in conjunction with any of the existing agreements will bring in milestone payments for Lexicon.

On another note, the fact that all of these products are in Phase II brings up some additional notes and concerns. The current market cap is about as high as I like to go with companies that have nothing beyond Phase II and because 'product to market' is still a long ways away, financing is always an issue.

That being said, the company is not in any immediate need to raise cash, but rest assured there will be some dilution before it's all said and done - in my opinion.

LXRX is a decent long term speculative play, in my opinion, but I would like to have some trading shares on hand to play any spikes and dips in order to end up on 'house money' here because I don't wholly trust companies with nothing beyond Phase II.

Keep in mind that these are my initial impressions; invest according to your own DD and tolerance for risk.

UPDATE: After the market closed on Thursday, Lexicon Pharmaceuticals announced that their investigational new drug, LX1031, a tryptophan hydroxylase (TPH) inhibitor, demonstrated positive results in clinically important parameters for the treatment of non-constipating irritable bowel syndrome (IBS). Top-line results showed that treatment with one gram of LX1031 four times daily produced a statistically significant improvement in global assessment of relief of IBS pain and discomfort over the four-week dosing period as compared to placebo (p=0.0465).

The Phase 2 clinical trial, which began at the end of December 2008, was a four-week, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LX1031 and its effects on symptoms associated with IBS. Shares of LXRX rose 18.71% after hours.

Disclosure: Long TTNP and BDSIVinny Cassano also authors the popular stock investing web site VFC's Stock House.

On 9/24/09, DNDN announced plans to file an amendment to its existing BLA seeking FDA approval in mid-November for Provenge with a possible decision by the Agency likely to occur around mid-2010. The Company will have the manufacturing capacity to generate possible sales of $60-125 million during 2H10 until full capacity is achieved in late 2011.

On 9/24/09, Chelsea Therapeutics (NASDAQ: CHTP) announced top-line results from Study 302, the first of its two Phase 3 trials of Droxidopa for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). While Study 302 demonstrated that Droxidopa showed a strong symptomatic benefit during the open-label dose titration and run-in phase of the trial, a preliminary review of the data indicates it did not demonstrate a statistically significant improvement relative to placebo, as measured by the mean score of Item 1 (dizziness or light-headedness) of the Orthostatic Hypotension Symptom Assessment (OHSA) during the double-blind phase of trial, the study's primary endpoint. Droxidopa was safe and well tolerated, with no significant related adverse events reported.

Another Phase 3 trial, Study 301, was previously reviewed by the U.S. Food and Drug Administration (FDA) and awarded a Special Protocol Assessment (SPA) in February 2008. In addition to the SPA, the FDA has awarded Chelsea Fast Track designation for its pivotal program in NOH.

On 9/24/09, Cephalon (NASDAQ: CEPH) announced that the FDA granted a priority (six-month) review for its supplemental New Drug Application (sNDA) for NUVIGIL (armodafinil) Tablets [C-IV], which was filed in June of this year. The FDA decision on approval of NUVIGIL as a treatment for improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel is expected by 12/29/09 and there is currently no FDA-approved treatment for this indication.

On 9/24/09, OraSure Technologies (NASDAQ: OSUR) announced that it has been awarded a 36-month contract for its OraQuick ADVANCE(R) Rapid HIV-1/2 Antibody Test with Premier Purchasing Partners, L.P., that is effective 11/1/09 and provides Premier's more than 2,200 member hospitals with pre-negotiated pricing and terms for the purchase of OraSure’s test, which is the first and only FDA-approved and CLIA-waived rapid point-of-care test that can detect antibodies to both HIV-1 and HIV-2 in 20 minutes, using oral fluid, finger-stick or venipuncture whole blood or plasma specimens. Additionally, the OraQuick ADVANCE(R) test is the only rapid HIV test offered through Premier's ASCEND(TM) (Accelerated Supply Chain Endeavor) program, a group purchasing program designed to help participants achieve and sustain rapid improvements in supply chain performance. Currently, more than 90 participants representing approximately $2.7 billion in supply chain purchasing volume and close to 24,000 hospital beds are collaborating to share best practices in supply chain efficiency as a part of the program.

On 9/24/09, Genzyme (NASDAQ: GENZ) announced that its randomized Phase 3 clinical trial investigating Campath (alemtuzumab) in combination with Fludara (fludarabine phosphate) in relapsed or refractory chronic lymphocytic leukemia (CLL) patients met its primary endpoint by demonstrating a significant improvement in progression free survival (PFS). Study results from this interim analysis are expected to be submitted to the American Society of Hematology meeting held in December.

GENZ stated that, pending approval, the FluCAM dosing regimen used in the Phase 3 trial will extend the use of Campath by giving physicians an important alternative treatment regimen for their patients with progressive disease. In the CAM314 trial, patients in the FluCAM arm had lower total exposure to Campath and Fludara when dosed in combination, as compared to the labeled, single-agent dosing regimen of each drug for the treatment of CLL.

Based on the study’s positive findings, Genzyme intends to seek regulatory approval in the United States, European Union, and other countries to further broaden the Campath label to include the use of this combination regimen. If the expanded label is granted, Campath, marketed as MabCampath® in Europe, would be the first humanized monoclonal antibody approved as both a single agent and in combination therapy for the treatment of CLL.

In collaboration with NIH scientists, Dr. Kovach / Lixte Biotech (OTC: LIXT.OB) have a new publication (Cell Cycle 8:20, 1-4; October 15, 2009) which is entitled, “Enhancement of cancer chemotherapy by simultaneously altering cell cycle progression and DNA-damage defenses through global modification of the serine/threonine phospho-proteome.” To summarize, Lixte’s lead compound has demonstrated positive preclinical results and has the potential to greatly enhance the cancer killing effects as part of combination treatment with chemotherapy drugs that target DNA as their mode of action such as temozolomide and doxorubicin. Lixte’s lead compound has a counter-intuitive mode of action that involves speeding up the cell cycle / DNA replication process of cancer cells despite the presence of chemo-induced DNA damage.

These cancer cells would otherwise lie dormant and repair the DNA damage caused by drugs such as Temodar, but in combination with Lixte’s compound, the cancer cells speed through the cell cycle / replication process to their demise. The authors of this article conclude that (1) the absence of toxicity in preclinical / animal model studies suggests that specific mutations in the signaling pathways regulating the cell cycle in cancer cells make them more vulnerable to this mode of action as compared to normal cells and (2) the mode of action of Lixte’s compound (global modulation of the serine-threonine phospho-proteome) may represent a general method of enhancing the anti-cancer effects of cytotoxic chemotherapy drugs by exploiting molecular defects in cell cycle regulation for targeted killing of cancer cells.

As a follow-up to my article earlier this week, Cytori’s (NASDAQ: CYTX) Cardiac Celution: Encouraging Interim Results, a 31-page PDF is now available at the BioMedReports.com research section in the medical / scientific reports section for a presentation earlier this week by Dr. Francisco Fernandez-Aviles (who kindly sent me the file today) at the 21st Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco in a session entitled, “Update on Adipose Cells for Chronic Ischemia.”

 

Disclosure: Long CYTX.

See my full disclaimer at MikeHavRx.com (bottom of any page).

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