Thursday, December 30, 2010

CytRx is an Up and Coming Biopharma Company with 3 Promising Candidates.

CytRx Corporation (NASDAQ: CYTR) is a biopharma R&D company that specializes in oncology therapeutics.  The pipeline has 3 drug candidates for various cancers, which have caught my attention.  I think that CYTR is an interesting company and their products have the potential to be widely used for treatment of cancers.  What is more impressive is that the company's 3 candidates have different mechanisms of actions and are being studied for a wide range of cancers unlike a lot of small cap companies that put all their eggs in one basket.  It will still be a few years before the candidates will hit the market.  Here's a brief overview:
  • Initiation of Phase 2b clinical trials of its drug candidate bafetinib in patients with high-risk B-cell chronic lymphocytic leukemia and advanced prostate cancer, and a pharmacokinetic clinical trial in patients with brain cancer. 
  • Phase 2 trials with its oncology candidate INNO-206 for soft tissue sarcomas and pancreatic cancer.
  • Tamibarotene for non-small-cell lung cancer (Phase 2b), and acute promyelocytic leukemia (APL).  
  • Seeking a potential partnership of molecular chaperone technology.  
  • 17% equity interest in RXi Pharmaceuticals Corporation, or RXi (NASDAQ: RXII).  There has been speculation for a long time about RXII being acquired by a big pharma.  Nothing has come to fruition.
CYTR is currently trading at $1.00 after sliding from a high of $1.11 from just a couple of weeks ago.   The price began falling after a site reported that a uptrend was spotted for CYTR.  Guess they got to the party when it was already over.  I began following the stock when it was trading at $0.74 during the summer.  I have studied papers of each of their candidates and think the company is onto something.  The market cap is $109 million, which is lower than similar biotech/pharma companies.  Perhaps the company is undervalued.    If you did not pounce on the stock during the uptrend, this is the perhaps the best time to join in on the action.  When CYTR begins Phase 3 trials, the price is surely to go up.  Phase 3 trials may begin in mid to late 2011 if everything goes as planned. 

I would like to just briefly explain the specifics of INNO-206 and its potential as it is similar to a project that I have worked on and many researchers around the world have studied. 

INNO-206 (formerly DOXO-EMCH) is a pro-drug of doxorubicin., a very commonly used drug in oncology.  Doxorubicin is used for a wide variety of cancers and has a liposomal nanotechnology formulation called Doxil, which has effectively replaced doxorubicin.  CYTR has the worldwide rights to INNO-206.  The design of the drug is similar to another nanotechnology formulated drug called Abraxane by Abarix Bioscience.  Whereas Abraxane is manufactured with paclitaxel attached to a blood protein called albumin, INNO-206 is doxorubicin modified with a chemical linker that binds with albumin when injected.  The linker breaks down when it enters the tumor environment which is acidic.  Abraxane and Doxil have been spectacular in reducing adverse effects of the original drugs.  I believe that INNO-206 can do better than these.  Doxil is the main competition for INNO-206; it would be interesting to see Phase 3 trials comparing the two formulations.

There are several issues that INNO-206 must address for wide acceptance by oncologists and pharmacists:
  1. Doxorubicin has a cumulative lifetime dose maximum.  This means a person can only receive a certain amount of it throughout their life.  It is unknown if this also applies to Doxil. 
  2. This relates to the previous issue.  Doxorubicin is known to be cardiotoxic and that is why it has a limit.  CYTR must demonstrate that there is no toxicity issues with the heart if they want a blockbuster oncology drug.  
  3. This relates to the previous two posts.  Patients with heart problems such as heart failure are exempt from taking doxorubicin.  By demonstrating that INNO-206 has no toxic effects on the heart, a greater number of patients can qualify for therapy.
  4. Doxil has a side effect known as Hand-Foot Syndrome.  This is another issue that INNO-206 must overcome.
  5. Doxorubicin can cause serious damage to the skin and blood vessels when being given to the patients.  By avoiding this, INNO-206 will gain favor with patients.
  6. The technology used in INNO-206 needs to demonstrate higher accumulation in the tumors.  
  7. CYTR must also evaluate if cancer develops resistance to INNO-206.  Resistance is a big drawback to effective doxorubicin treatment.
  8. Doxorubicin is used for many types of cancer.  Can INNO-206 be applied to these cancers?  Is CYTR willing to test 5+ types of cancer? Probably not off the back.
This may seem like an overwhelming list but this is what companies have to consider when bringing new drugs to the market.

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