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CytRx Announces Partial Clinical Hold On Main Drug, Big Buying Opportunity For Investors

Shares of CytRx Corporation (CYTR) fell as low as 10% in the day as the company had received notice that the FDA would place a partial clinical hold on its Aldoxorubicin drug which is being used in patients with multiple types of cancer. This type of news has brought the share price down for CytRx today but it is a great buying opportunity for investors because it is not a full clinical hold. What this means is that the FDA has stated that patients can continue with the Aldoxorubicin treatment that are currently enrolled in the clinical trial. Although as of now the company has to temporarily suspend enrollment for the time being until the receive further feedback from the FDA.

The partial clinical hold was based off the fact that one patient with advanced stage cancer had died, but was not enrolled in the clinical trial itself. That is because that patient was using Aldoxorubicin under the “compassionate use” program from the FDA. The “Compassionate Use” program was established by the FDA to allow people to take an experimental drug that would treat their unmet medical need despite that patient not being enrolled in the clinical study itself. CytRx says that it can easily address the FDA’s concerns in a timely manner and should have no problem having the partial clinical hold lifted. As soon as the clinical hold is lifted the company will be able to resume enrollment in the clinical trials using Aldoxorubicin.

The company is currently running multiple clinical trials with Aldoxorubicin and has one late stage phase 3 trial treating patients with Soft Tissue Sarcoma. Other clinical trials utilizing Aldoxorubicin include NSCLC — non-small cell lung cancer , glioblastoma — brain cancer, and other types of cancers. The company uses a currently marketed chemotherapeutic agent known as Doxorubicin but have attached their own acid sensitive linker that combines the drug compound into Aldoxorubicin. What this linking does is increase the efficacy of the drug while at the same time reducing the known adverse effects it has on patients. As the drug is already approved and with the known reduction of safety risks we believe that CytRx should be able to resolve this matter efficiently with the FDA.

Today’s fall is a great buying opportunity considering that the risk-reward  is now even more attractive. The company can apply its linker technology to many different types of currently approved chemotherapeutic compounds that could improve efficacy while keeping toxicity to a minimum. The company has already displayed that its Aldoxorubicin compound can perform efficiently. For instance in a trial with patients with soft tissue sarcoma the company reported an improved progression-free survival. Patients treated with Aldoxorubicin achieved progression-free survival with an average of 6.4 months which compared historically with placebo only achieving 3 months. Progression-free survival is the amount of time a patient lasts in the clinical trial taking an experimental drug without advancing their cancer to a worsening state. We think that investors should take a look into the prospects of this biotech and consider initiating a position after this partial clinical hold placed by the FDA. As with every biotech stock there will always be associated risks but this drop has created  a nice buying opportunity.

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Achillion Pharmaceuticals Continues To Impress With Hepatitis C Results In A Combination Study

Shares of Achillion Pharmaceuticals (ACHN) soared as much as 27% in yesterdays trading session after the company reported a combination study showed a 100% Sustained Viral Response — SVR — in patients with the Hepatitis C virus. The positive results were presented as a late-breaker poster presentation at the 65th Annual Meeting of the American Association for the Study of Liver Disease — AASLD. This conference is important for the fact that companies report to display next generation treatments against liver diseases such as Hepatitis C, Hepatitis B, NASH — Non-Alcoholic Steatohepatitis, and other advanced liver diseases. There are a lot of unmet needs in patients with liver diseases and any successful treatment being brought to market could generate billions of dollars in sales.

Achillion had chose to do a combination study using their hepatitis C drug ACH-3102 and combine it with an approved marketed Hepatitis C oral drug from Gilead Sciences (GILD) known as sofosbuvir. This treatment regimen was being done without adding the need for Ribavirin — an old standard of care therapy for Hepatitis C. The problem with Ribavirin is that it causes of a  lot of undue toxicity for patients and even then it doesn’t achieve substantial SVR for the Hepatitis C virus. The results showed that by combining both ACH-3102 and sofosbuvir all 12 patients in the study achieved a 100% SVR response with the genotype 1 Hepatitis C virus. That means in 12 weeks this combination study was able to clear the Hepatitis C virus in 12 weeks only without the need to add the toxicity of Ribavirin.

This is substantial news because Gilead’s drug sofosbuvir in genotype 1 Hepatitis C virus patients can obtain up to about a 90% SVR on its own. That means now that if Gilead wants to get its hands on being able to create this combination oral drug regimen it would have to consider acquiring Achillion Pharmaceuticals. For this reason we believe that Achillion will eventually be bought out either from Gliead Sciences or any other big pharmaceutical company needing to incorporate a Hepatitis C drug to their pipeline. The need for big pharma companies to acquire Hepatitis C treatments is for the fact that the market for this disease is in the billions of dollars as evidenced by Gilead’s sofosbuvir drug which produced $2.8 billion dollars in sales just in Q3 2014 alone.

There is a lot of competition now in the Hepatitis C space but Achillion showing 100% SVR in all patients is truly remarkable in itself. The share price for Achillion surged up as much as 27% but we believe that the share price may steadily rise over the next few days as investors realize that the company could be an eventual takeout candidate by a larger pharmaceutical entity. For that reason we believe that Achillion is a good long term stock to hold as the share price should continue to climb in the coming months and might even produce a nice big payday as it is finally acquired. It is good to see though that treatments are being produced for the Hepatitis C virus as there are about 130 to 150 million people with chronic infection of the virus. Without treatments for the hepatitis C virus these patients’ livers would be come damaged/scarred leading to other symptoms and even possibly death.

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Geron Shares Surge 25% After The Removal Of A Clinical Hold By The FDA For Imetelstat

Shares of Geron (GERN) surged as much as 25% after the company announced that the FDA has removed the full clinical hold on one of its key drug known as Imetelstat. Back in March of 2014 the FDA has placed a full clinical hold of Imetelstat due to concerns that the drug caused liver toxicity in patients. Shares of Geron tumbled down as much as 67% trading down to $1.42 per share at that time of the FDA clinical hold. After yesterdays 25% surge on the news of the removal of the FDA clinical hold for Imetelstat, Geron now trades at around $2.80 per share.

This removal of the FDA clinical hold was key for the company as Imetelstat was due to start a phase 2 trial in patients with myelofibrosis. Myelofibrosis is a rare type of blood cancer where the bone marrow in the body becomes damaged by scarring and it disrupts the patient’s ability to produce blood cells at a normal production rate. The FDA placing clinical hold of this drug was a huge blow not only to Geron but also to the patients being treated with Imetelstat. This is because Imetelstat showed the ability to actually reverse the affects of myelofibrosis again allowing the body to produce blood cells in the bone marrow at a normal production rate.

Geron intended to start a phase 2 trial at the beginning of 2014 but the FDA placed that full clinical hold on Imetelstat stating that the drug showed some concerns of patients displaying Liver Function Test — LFT — abnormalities. With this clinical hold now removed by the FDA Geron plans to launch a phase 2 trial with Imetelstat targeting myelofibrosis by the 1st quarter of 2015. To remove the clinical hold Geron had data on hand that would refute the fact that Imetelstat caused such drastic safety concerns. The company first submitted data from another ongoing phase 2 trial with Imetelstat showing that the patients that had shown LFT abnormalities eventually resided back down to normal baseline levels. The second data Geron submitted to the FDA was additional data from a pre-clinical trial of Imetelstat in animals displaying that long term chronic use of Imetelstat showed no sign of chronic liver damage. With this data on hand the FDA had decided to remove the full clinical hold of Imetetlstat, and now the company can continue on with its groundbreaking science of being able to reverse a rare form of blood cancer.

We believe that shares of Geron should continue to climb as more people catch on that Imetelstat is a great cancer drug that has the ability to reverse the effects of certain blood cancers. Therefore the company has a bright future ahead but it will take time to get there as the phase 2 trial is set to start in early 2015. Investors will need to have a long-term approach to investing in this biotech as the trial will take about a year or more to display results from the time it resumes. With further positive confirmation of Imetelstat we believe that Geron’s Share price should continue to rise overtime establishing itself as a great biotechnology company in the competitive blood cancer space. The company can eventually initiate additional clinical trials in other forms of blood cancer that should also substantially increase its future value over time.

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Novavax Is A Great Ebola Vaccine Company To Keep An Eye On

Recently the CDC had first announced that the Ebola Virus could only be transmitted by physical contact of fluids from the other person. For awhile now many biotechnology stocks have traded higher on this premise as people feared a much larger scale spread of the Ebola Virus. Although it seems now that all this panic wasn’t for nothing as the CDC has finally admitted that the Ebola Virus can travel up to about 3 feet through the air to infect another person. With this new challenge it seems that the panic is justified and more treatments are needed that can quickly help in case of a world global health crises arises with the Ebola Virus.

One such company to keep an eye on would be a biotechnology company known as Novavax (NVAX). Novavax is a leading biotechnology company that is capable of mass producing a lot of vaccines in a short amount of time because of a technology known as Matrix-M. Novavax announced the other day that the company would scale up manufacturing of its Ebola vaccine by the 1st quarter of 2015. To understand the company’s Matrix-M technology we need to find out what it is and why it is able to be scaled up in manufacturing so quickly?. The Matrix-M technology is different from other vaccines because it is able to carry multiple antibodies as opposed to other vaccines only being able to incorporate a few antibodies. This difference is huge because Novavax can increase the efficacy of its vaccine with a lot smaller doses than other vaccine companies can. This leads to Matrix-M having less manufacturing costs and less system toxicity for those patients who take the Matrix-M vaccine. Unlike other vaccine companies Novavax doesn’t need to grow a live virus as its technology allows them to create virus-like particles at a rapid pace. All these advantages allow the company to quickly mass produce a lot of vaccines needed in case of a an epidemic such as this Ebola Virus eventually coming to fruition.

Novavax released these pre-clinical Ebola results at a medical conference known as the 8th Vaccine and ISV Conference. These results showed that Novavax’s Matrix-M technology was able to increase efficacy against the Ebola Virus as opposed to other current vaccine treatments that do nothing to increase efficacy. The vaccine is the first of the Ebola Vaccines that deal with the 2014 Guinea Ebola Strain which is responsible for the current Ebola Epidemic in West Africa. Matter in fact the Matrix-M technology from Novavax was able to increased efficacy against the Ebola virus by 10 to 100 fold times greater than normal. That is a huge boost to efficacy considering the lack of treatments out there for the Ebola Virus.

Novavax is moving along quickly because of their adjuvant Matrix-M technology and is expecting to start a phase 1 clinical trial in humans by December 2014. The company has the ability to help mass produce Ebola vaccines that may be used in case an epidemic occurs here in the states and abroad to other geographical regions. The company has a good chance to report good results from its phase 1 trial against Ebola because the Matrix-M technology has already been proven to work in a phase 2 trial of Influenza and a phase 2 trial of RSV — Respiratory Syncytial Virus —  in humans. There are many other good biotech companies to watch on these ebola headlines of course but we think that Novavax is an under the radar company for quite some time now that may finally be breaking out to bigger things. At the current share price of $5.80 per share we think the risk/reward scenario is attractive and a possible long-term position may yield excellent future gains for investors.

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Inovio Pharmaceuticals: The Partnerships Keep On Rolling In

Today Inovio Pharmaceuticals (INO) announced that it is collaborating with MedImmune and The University of Pennsylvania to create monoclonal antibodies — mAbs — that will be used to treat a multitude of infectious diseases. MedImmune is the research arm that is part of a big pharmaceutical company known as AstraZeneca (AZN). On top of this collaboration the Defense Advanced Research Projects Agency — DARPA awarded this collaboration $12.2 million dollars to run pre-clinical trials in certain infectious diseases. DARPA is a government body that is responsible for creating technologies that can be used to protect national security. The three diseases that will be targeted are  the influenza virus, Pseudomonas aeruginosa and Staphylococcus aureus.

MedImmune’s mAbs are already out on the market with a lot of success against certain diseases. Inovio has already provided proof of concept of its DNA-based vaccines in the most recent results of its phase 2 trial against cervical dysplasia. Together these companies hope to create an improved version of these mAbs that will help change the fight in medicine against these infectious diseases that target so many people worldwide. What makes this collaboration so great is that the CEO of Inovio Pharmaceuticals Dr. Joseph Kim has stated that the company’s DNA-based mAbs have already shown great results in their own pre-clinical studies being able to demonstrate great clearance of the virus along with protection from the virus itself.

The technology of the current mAbs have led to great substantial acceptance in the pharmaceutical industry but have very many problems. They way they are manufactured now is very costly and they don’t have a strong enough lasting effect once they are placed into the body. That is why MedImmune is interested in this collaboration because Inovio’s DNA based vaccine technology would allow mAbs to be produced at a cheaper cost and along with electroporation produce a much longer lasting effect that would enhance the efficacy of the drug itself. What makes Inovio’s technology so great is that it can easily manufacture its DNA-based vaccines at a quicker rate than the current mAbs from MedImmune.

This additional partnership further establishes Inovio Pharmaceuticals as leading the way to help improve vaccines that can treat many types of diseases. One previous partnership that was announced awhile ago was with a big pharmaceutical company known as Roche (RHHBY) which agreed to collaborate on two pre-clinical targets. These two pre-clinical targets being worked on together with Roche are prostate cancer — INO 5150 — and hepatitis B — INO1800 — both of which will used Inovio’s Electroporation technology. Roche made an upfront payment of $10 million dollars and potential milestone payments of up to $412.5 million dollars as the vaccines advance. Inovio pharmaceuticals has been on a roll with these partnerships and we believe that the future will bring in additional partnerships because of the flexibility of Inovio’s technology. We think that Inovio is a great long term buy that has DNA-based vaccine and electroporation technology that will change the way vaccines treat today’s most dangerous diseases.

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Alnylam Keeps Making New Strides In RNAi Research

Shares of Alnylam Pharmaceuticals (ALNY) spiked as high as 18% yesterday after the company announced results from a phase 2 open-label study in patients with TTR-Amyloidosis in FAP. For starters open-label study means that Physicians and patients know that they are getting the Patisiran drug — Alnylam’s RNAi drug — and no placebo counterpart. The company is currently conducting a phase 3 trial for Patisiran in FAP known as the “APOLLO” trial. The addition phase 2 study was to run a study where investigators can see how the drug performs over a period of time instead of having a closed analysis. TTR-Amyloidosis is a disease characterized by excessive folding of the protein thereby depositing into pockets of the peripheral nerves and heart.

Alnylam is using Patisiran to knock down the TTR-genes that are produced in the liver itself. The RNAi drug itself using Tekmira Pharmaceuticals (TKMR) LNP — Lipid Nanoparticle — delivery technology is intended to knock down the genes of the diseases. The knocking down of theses genes is intended to improve the patients life expectancy and or prevent further damage in their body.  In these phase 2 results reported the other day the Patisiran drug was able to achieve a knockdown of 90% of the TTR-Amyloidosis FAP disease over a 9 month period. Life expectancy for patients with TTR-Amyloidsosis in FAP is around 5 to 15 years from the moment the disease takes effect. There are about 10,000 patients Worldwide with TTR-Amyloidosis FAP disease therefore Alnylam should be able to give the Patisiran drug to this orphan disease. Orphan diseases are diseases that are an unmet medical need that affect less than 200,000 patients worldwide. This gives Alnylam special perks if this drug makes it past the final phase 3 clinical trial like longer exclusivity in sales, and quicker review from the FDA.

In addition the efficacy of Patisiran was measured using a score technique known as the Modified Neuropathy Impairment Score — (mNIS+7). The basic thing to know about this is that patients with TTR-Amyloidosis end up with 10 points or higher on the score taking a placebo drug. on the other hand taking Patisiran the patients actually decreased by about 1 point. Generally this is good because patients taking Alnylam’s drug were able to avoid going up in score like placebo patients have done in the past. This shows the true efficacy of RNAi science, and the promise of RNAi for the future.

Alnylam is currently the leader in RNAi at the moment but that doesn’t mean it won’t change later down the line. Despite that this company continues to see excellent clinical trial results and already has an RNAi drug in a phase 3 clinical trial. There are no approved RNAi drugs on the market so Alnylam has the opportunity to become the first RNAi biotechnology company to have an approved RNAi drug. We believe the company to be a great long term buy as the company advocates its 5×15 program. This means that Alnylam expects to have 5 mid stage drugs by 2015 in the RNAi space. Sanofi (SNY) is already excited about Alnylam’s prospects as it has already acquired about 18% of the company. We believe that Alnylam is positioned well in the RNAi space and will continue to post positive results for other drug compounds in the clinic.

 

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Rxi Pharmaceuticals Posts Positive Phase 2a 3-month Results In Hypertrophic Scars

Today the CEO and President of Rxi Pharmaceuticals (RXII) announced additional results from the phase 2a trial using RXI-109 against hypertrophic scars. The previous article we wrote discussed the early 1-month results of RXI-109 against hypertrophic scars in phase 2a. As we stated in this previous article 1-month is too short of a time span to tell whether or not RXI-109 achieved clinical efficacy or not. Regardless of this the cohort 2 results for RXI-109 were better than placebo even at the 1-month time point. Today’s results show how the RXI-109 drug worked on hypertrophic scars at a 3-month time point shown by slides 15 and 16 shown here “Rxi BioForum Presentation slides”

We also mentioned before that if the 1-month photos looked good, then the 3-month photos would look even better and we were right. This is because hypertrophic scars take 3 to 6 months to grow back fully therefore cause an irrational panic sell off on the 1-month results because investors didn’t understand the clinical data. Today’s pictures shown  in the Rxi Presentation slides shown above have now validated the sd-rxRNA platform. This means now we know RNAi — RNA interference — can now be used to turn off specific genes of a particular disease. With Today’s news the share price of Rxi Pharmaceuticals should eventually gap up to a higher market cap of at least $500 million close to its other peers in the RNAi industry like Tekmira Pharmaceuticals (TKMR) and Arrowhead Research Corp (ARWR).

This validation is important because now the company is at a reduced risk investment level since we now know that RXI-109 works in humans 3 months post surgery compared to a placebo compound. Getting this drug to market would be a huge step to help the company move itself forward as it could stand to make $1 billion to $1.5 billion dollars in the U.S. alone. Also this should help Rxi  to obtain a partnership easily now as it has proven its technology to work in humans in a mid-stage trial. The company though is not a one trick pony because it is advancing its ophthalmology pipeline as well and is expected to file an IND for RXI-109 in eye diseases in the coming months. In other words Rxi is just getting started with its RNAi technology and should continue to do well in the coming years.

Going forward though there are plenty of catalysts that should be expected from Rxi. Some of them include the addition of another midstage clinical trial to the pipeline. This is listed at the end of the slides but as of now it is not clear what the company will be adding to the pipeline. The company says it expects to report about this addition of the mid stage phase 2 trial by the end of 2014 as mentioned by the CEO in the presentation. Other Catalysts should come at the beginning of 2015 when the company expects to report clinical trials on its other early stage programs like macular degeneration — vision loss in older adults– and Retinoblastoma — eye cancer in children under 15. We think that investors now have a golden opportunity to enter a biotechnology stock that holds a promising future and has completely de-risked itself with these great phase 2a results.

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Clovis Oncology Should Not Be Ignored

On September 28th 2014 Clovis Oncology (CLVS) announced that it had reported positive results in a phase 2 clinical trial in treating patients with Ovarian Cancer. The phase 2 trial was known as the ARIEL2 study and had recruited 20 patients to take 600 mg of a drug compound known as Rucaparib. Rucaparib is an oral inhibitor pill that these patients take to inhibit the genes of the Ovarian cancer known as PARP-1 and PARP-2. This type of Ovarian Cancer is a type where patients have a BRCA mutation gene. This means that this cancer is a type of a rare cancer that occurs in ovarian cancer patients. Clovis though is currently using Rucaparib to target tumors with defective DNA repair functions. The first two initial tumors being targeted are in Ovarian Cancer and Pancreatic Cancer.

The company stated that of those patients taking Rucaparib 95% (14 out of 15) had a Disease Control Rate — DCR. DCR means that the patients in the study either had a complete response, partial response, or a stable disease. This bodes well for the compound as it shows that patients being treated are able to not only control the spread of the cancer but somewhat prohibit it from forming. Eight of the twelve patients that achieved a partial response in the trial did so in week 6 of taking the drug compound. These preliminary data were presented at a conference in Madrid known as ESMO — Europen Society Of Medical Oncology. As we can see in this early clinical evidence Clovis Oncology seems to be doing well with its Rucaparib drug compound, and still has additional oncology compounds in its pipeline.

There are about 21,980 cases of Ovarian Cancer in the United States in 2014 thus far  and a limited amount of treatment options for these patients. Clovis even discovered in its trial that patients without the BRCA gene Ovarian Cancer still benefited with treatment from using Rucaparib. This finding can be established in new phase 2 trials later down the line in other Ovarian Cancer patients. The stock surged on Monday September 29, 2014  by 13% on the news, but today has declined down by 6% to close the day at $45.36 per share. Clovis Oncology is an attractive oncology company with variety of clinical compounds that may help improve the lives of these cancer patients.

We believe that Clovis Oncology should not be ignored because as it stands now the company is set up to be possibly bought out by another big pharmaceutical company that may want to add to their oncology pipeline. We believe that Clovis would be a great investment for investors looking for future growth and potential acquisition target. Investors should definitely keep an eye on this biotech stock in the coming months. Matter in fact Clovis expects to report additional phase 2 trial data on this ARIEL2 study in patients with Ovarian Cancer this coming November at a Symposium conference. This should give another catalyst for the share of Clovis and should provide investors with further guidance on the future of the company’s direction with its cancer compounds.

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Tekmira Pharmaceuticals Just keeps On Shining With Ebola Drug

Shares of Tekmira Pharmaceuticals (TKMR) surged as much as 17% to a share price of $23.61 per share after the FDA and Health Canda have agreed to allow TKM-Ebola to be given to patients under the “compassionate use” clause. Also in addition to that news in the morning news came in after the bell on September 22nd stating that TKM-Ebola was used to treat Dr. Sacra who was infected with the Ebola virus. Dr. Sacra was infected because he was attempting to help patients in West Africa, but was afflicted with the disease himself. It was disclosed that TKM-Ebola was one of his forms of treatment but he also received other experimental drugs as well.  This is a great advancement for Tekmira Pharmaceuticals as it may be able to obtain some revenue from treating patients with its drug. Although investors should note that this Ebola drug for Tekmira won’t generate billions of dollars, not even millions of dollars either. That is because as of right now there are limited patients that currently carry the ebola virus, and it may not be a profitable disease to treat in the future. In the interim though the stock will trade higher on the ebola hype. This news is bullish for Tekmira in the short term although it is unclear how it will affect the share price in the long term.

The share price going up 17% was a nice boost, although today the stock did continue some of its gain with additional news. The news today was that Tekmira would be allowed to test their TKM-Ebola drug on patients infected with the ebola virus. This goes a long way to where many months ago the FDA put the TKM-Ebola drug on hold due too safety concerns. This goes to show though how quickly the tide can change in the biotechnology industry and investors need to be ready when this type of volatility occurs.  On top of testing out their ebola drug on patients deemed to be infected by the ebola virus, Tekmira has stated that it has been selected to take part in clinical trial in Africa as part of an international effort to curb the spread of the ebola virus.

Investors should take note though what was mentioned above. More tests are needed to particularly confirm that TKM-ebola was the drug responsible for saving Dr. Sacra’s life. Although we believe it is a high possibility as Tekmira’s LNP — Lipid Nanoparticle — technology encapsulates siRNA or small interfering RNA molecules. The basic function of these molecules are to stop the genes of the ebola virus from producing proteins and then spreading throughout the body. TKM-ebola if proven to succeed in other patients will produce a great confirmation for Tekmira’s LNP technology platform. The company has other pipeline candidates that it is working on like its Oncology franchise. Tekmira’s oncology franchise is targeting solid tumors and those results are expected to come in several months. We believe that Tekmira Pharmaceuticals is a great long term name regardless of the ebola drug compound. Investors should note one key thing about Tekmira and that is that the company is not dependent on the TKM-ebola drug. The TKM-ebola drug is just an extra boost for the stock, but in the long term the company can succeed without TKM-ebola.

 

 

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Rexahn Pharmaceuticals Looks To Find A New Partner Once Again For Cancer Compound

Today Rexahn Pharmaceuticals (RNN) announced that it will be attending the BioPharm America 2014 Partnering Conference. This is significant because the previous partnership with Teva Pharmaceuticals (TEVA) came from exactly the same conference. This conference allows small-cap biotechnology companies to sit down with a lot of various pharmaceutical companies looking for innovative drug companies to partner with. Rexahn was able to partner out a drug compound known as RX-3117 with Teva at this conference.

There is no guarantee that Rexahn will be able to establish a partnership at this conference, and even if the company does find a pharmaceutical company to partner with it could take months to establish a deal. Therefore we don’t recommend that investors buy shares of Rexahn only because of a potential partnership but because they believe in the future value of the RX-3117 drug itself. First to understand what RX-3117 is and why a pharmaceutical company would want to form a partnership with this compound we have to understand its value. RX-3117 is a nucleoside analog compound that inhibits both DNA and RNA synthesis.This inhibition of Synthesis the blocking of DNA and RNA molecules from combining to form a protein thus creating new cancerous cells.

The key point for RX-3117 is not only that it would block both DNA and RNA from synthesizing but the drug compound only targets cancerous cells and leaves healthy cells alone. A lot of biotechnology companies are looking towards new treatments for cancer that avoid the toxicity of current therapies like chemotherapeutic drug compounds. Even though the partnership between Rexahn and Teva didn’t work out it does not mean that Rexahn should stop exploring options to partner this drug compound with anotehr big pharmaceutical company. A lot will need to be done to prove the power of the RX-3117 compound but Rexahn establishing a partnership will be helpful for moving the company forward.

So despite the breakup Rexahn should be able to establish a new partnership with another biotechnology company. The partnership may not come instantly, and it will be a long road but it is in the company’s best interest to partner out the compound. Especially a company that is in early clinical stage testing and has no other means to generate revenue. If proven successful in clinical trials RX-3117 could be applied to many types of solid tumors and could generate billion of dollars in revenue. RX-3117 is in great shape because the compound is currently in the middle of recruitment of the 4th dose group at (150mg) as the MTD — meaning maximum tolerated dose patients can sustain without a lot of toxicity — has yet to be established. This bodes well because the higher the MTD can go the greater the efficacy of the compound during the readout in the future. Rexahn expects the phase 1b trial for RX-3117 enrollment to be completed by Q4 2014 or Q1 2015. The wait is not too bad as the company is expected to also report on other compounds in the clinic. Rexahn is expected to report the phase 2a trial for Archexin by Q4 2014, and final results for Supinoxin phase 1 in Q4 2014. We believe that Rexahn is a nice long term hold, and the entry share price point is attractive at $0.74 per share as well.