|Potential Payoffs Spuring Big Board Biotechs|
|By Staff and Wire Reports|
|Tuesday, 12 August 2014 02:59|
Shares of Tekmira Pharmaceuticals (NASDAQ:TKMR) were up again on Monday, adding to the 45% spike seen on Friday after the FDA loosened a hold on the firm's Ebola treatment- which is still in the development pipeline.
After closing on Thursday afternoon at $14.27 per share, Tekmira Pharmaceuticals shares traded as high as $26.05 on Monday before closing the day at $23.80, up +14.98%.
In Thursday evening's press release, Tekmira said, "the U.S. Food & Drug Administration (FDA) has verbally confirmed they have modified the full clinical hold placed on the TKM-Ebola Investigational New Drug Application (IND) to a partial clinical hold. This action enables the potential use of TKM-Ebola in individuals infected with Ebola virus."
The Canadian biotech firm announced that the Federal Drug Administration knocked down an important barrier to its medicine reaching some infected patients.
Reports had the FDA moving the drug from a "full hold" to a "partial hold," which means Tekmira can use the drug in limited experiments.
"We are pleased that the FDA has considered the risk-reward of TKM-Ebola for infected patients," said CEO Mark Murray in a statement.
In July, we told readers that the Tekmira sell off following the initial FDA clinical hold on the company’s Phase I trial for TKM-Ebola was exaggerated.
The reasoning behind the FDA’s initial clinical hold had to do with the inflammatory response that is regularly seen after administration of Tekmira’s Ebola therapeutic at higher doses. This seemed to be caused by an elevation in cytokine levels, which has a direct correlation with the level of immune system activity in the body. This increased immune system activity led to serious adverse events in patients, including nausea, emesis, sinus tachycardia, and hypotension.
To combat autoimmune problems in previous trials, Tekmira used steroids on patients to proactively. In this Phase I trial, Tekmira did not suppress patients’ immune systems prior to infusion because they believed that the immune-stimulating effect would be lessened with 3rd gen products.
Although they are based on the same SNALP LNP platform, the HBV therapeutic will be developed to interact with hepatocytes (liver cells). This could make the drug more efficient at lower doses, and could reduce the severity of side effects.
There are skeptics who think that none of the drugs which are currently in development- might help. Among those skeptics is the man who helped discover the virus nearly 40 years ago. "We don't know exactly how the virus causes death," says Dr. Peter Piot, who discovered Ebola in 1976 shortly after he qualified as a Doctor of Medicine at the University of Ghent (Belgium).
In an interview with CNN Money, the respected scientist says "We don't know enough how to treat someone with this viral infection. We don’t know exactly how to prevent it through a vaccine."
Still, GlaxoSmithKline (NYSE:GSK) is working with the World Health Organization and is reportedly starting trials for a vaccine next month. All of this as Ebola continues to spread through West Africa.
An Ebola vaccine should be ready for public use by 2015, the United Nation’s health agency has said.
Other firms who have a stake in the Ebola virus game did not see the impact that Tekmira has had on the market.
NanoViricides Inc (NYSEMKT:NNVC) which reports that it is restarting its drug development program to combat Ebola closed at $4.12 down 3.74% for the day; joining BioCryst Pharmaceuticals (NASDAQ: BCRX) which ended at $13.56 down -2.87%.
Sarepta Therapeutics (NASDAQ: SRPT), which has developed a treatment for Ebola that has had success in combating the disease in primates, did see a 7.39% to $22.66 on slightly lower than average volume.
Also on Monday, shares of CEL-SCI Corporation (NYSEMKT:CVM) saw shares gap up slightly and close +3.77% higher after investors spotted a positive development reference to the firm's arbitration proceedings against inVentiv Health Clinical, LLC in the company's newly filed quarterly report. For the first time, investors are hearing that on June 24, 2014, the arbitrator in the case denied inVentiv’s motion to dismiss the case.
This is seen as a bullish development since inVentiv had moved to dismiss certain claims in December 20, 2013.
In late October of 2013, CEL-SCI commenced arbitration proceedings against inVentiv, the Company’s former clinical research organization, alleging breach of contract, fraud in the inducement, and common law fraud. They currently seeks at least $50 million in damages- a sum which could significantly impact the firm’s market cap and share price.
CEL-SCI says they filed the arbitration because, among other reasons, the number of patients enrolled and treated in the study fell below the level agreed to with inVentiv. In April 2013, CEL-SCI management fired Ventiv and replaced it with Aptiv Solutions, Inc. and Ergomed Clinical Research Ltd.
Replacing inVentiv with the new CROs has undoubtedly resulted in faster enrollment. The company announced last month total patient enrollment of 232 people, more than one-quarter towards their goal of 880 by the end of next year.
“We reached an important milestone in July with total patient enrollment reaching 232, which is over one-quarter of the total 880 patients we expect to enroll by the end of 2015. We are on track with the pace of enrollment, which should accelerate in the fall based on the increasing number of clinical centers joining our study,” stated CEL-SCI Chief Executive Officer Geert Kersten in a news release last week. “In the past three months alone, we have received clearances to expand the trial into the United Kingdom, Austria, Sri Lanka, Turkey and France, while we also continue to add clinical sites in North America.”