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Serepta Shares Fall Following Release of Clinical Trial Data

Author Hopeanne Wohlers

Shares for Serepta plunged on Thursday after clinical trial data suggested an accelerated decline in walking ability for trial patients being treated with the company’s experimental DMD drug, eteplirsen.

Details of the Eteplirsen Clinical Trial

According to Reuters, Serepta Therapeutics Inc’s muscle wasting disorder drug, eteplirsen, has caused an accelerated decline in trial patients’ walking ability after three years of using the drug.

Eteplirsen is used to treat Duchenne muscular dystrophy, DMD, which is a degenerative disorder that inhibits muscle movement; DMD affects one in every 3,600 newborn males. Since there is no known cure, DMD patients generally die before age 30.

The drug’s trial includes 12 patients who were given the drug or a placebo as researchers evaluated the production of dystrophin after 25 weeks.

After 144 weeks, the patients treated with the drug continuously from the beginning had a reported loss of up to 32.2 meters from baseline walking ability, which is measured by a six-minute walk test. Patients who began on the placebo and then switched to etepliersen suffered an even larger decline of 107.4 meters.

Eteplirsen’s trial results sent the company’s shares down 28%, but analysts state that the company is still on track for approval of the drug for the end of the year.

Shares for Similar Drugs Drop

The results of the eteplirsen study caused a decline in the rival drug, Prosensa Holding NV’s Drisapersen, as well, since both skip a faulty section of the gene in order to produce dystrophin. Drisapersen shares declined 5 percent.  

Debjit Chattopadhyay, an analyst for Roth Capital Partners, wrote, “The reason for the sell-off in the stock is related to the acceleration in the rate of decline over the last six months, which can be taken as waning in eteplirsen efficacy”.

The US Food and Drug Administration are suggesting an alternate plan for the approval of eteplirsen though since Sarepta’s marking application was said to be premature in 2013. The FDA stated that safety and efficacy data from studies that did not use placebo groups could further support the company’s marketing application.

However, Brian Kelin, an analyst at Stifel & Co, stated that the drug’s ability to show an improvement over the placebo group still qualifies the drug as effective because “If, after 144 weeks, you're concerned about disease progression, it's not a problem that you want… But it's better than no efficacy at all". Sarepta shares declined 12% to $22.55 according to the Nasdaq on July 10th.

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FDA Warns of Dangerous Drugs Contained in Weight Loss Supplements

Author Lucrecia Guerra

The U.S. Food and Drug Administration (FDA), is warning consumers not to buy six different weight loss supplements after determining they are made with a dangerous drug banned from the market since 2010. 

About the FDA Weight Loss Supplements Warning

According to the Plain Dealer, the weight loss supplements contain sibutramine, marketed under the trade name Meridia before its withdrawal from the market in 2010.

Sibutramine can be dangerous for people with heart conditions and increases the risk of having cardiovascular problems by 16 percent, according to clinical trials. The FDA has discovered the presence of sibutramine in more than 50 weight loss supplements sold as capsules, powders, slimming coffees and tea drinks.

Consumers who have taken weight loss supplements and experienced any side effects are encouraged to contact their doctor immediately and to report the incident to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Consumers can submit their complaint through an online form or by calling at 1-800-332-1088. 

Risky Weight Loss supplements Identified by FDA

  • Mix Fruit Slimming - sold by Amazon and other retailers, advertised to be 100% natural and free of any side effects. The product also contains phenolphthalein, another banned drug by the FDA due to carcinogenic potential. 
  • Lingzhi Cleansed Slim Tea - sold by Amazon and other retailers. The manufacturer claims the supplement can “help to improve digestion and speed up metabolism.”
  • Trim Fast - sold online and through some retailers, advertised as a diet aid used to control appetite, boost metabolism, and give energy. 
  • 24 Ince - which is a slimming drink advertised to help control weight while reducing cholesterol and fat levels. 
  • Slimming Diet by Pretty White - sold on eBay and other online retailers, advertised as being completely natural and safe. 
  • Lipo 8 - sold online and through some retailers. Lipo 8 is advertised as weight loss pill made from white kidney bean extract that eliminates fat before is absorbed into to the body. 

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FDA Clinical Hold on REG1/Revolixys Kit Phase III Trial

Author Brian Finehout-Henry

The U.S. Food and Drug Administration (FDA) has placed a clinical hold on a phase III clinical trial for REG1due to reports of serious adverse events.

REG1 Trial On Suspension Until Further Notice

On July 9, 2014, Regado Biosciences announced that the FDA had put a clinical hold on their REG1 phase III clinical trial.

REG1, also known as Revolixys Kit, is a two drug anticoagulant system, that is  currently in a suspended phase III trial, called REGULATE-PCI.

According to clinicaltrials.gov, the REG1 phase III study, NCT01848106, started in September 2013 and wanted to recruit 13,200 participants. The FDA clinical hold means that no new participants may be recruited and given REG1 and current participants are prohibited from being given further doses of REG1, until the FDA has decided it is safe to continue the trial.

According to Medscape, the REG1 study was halted by the Data Safety Monitoring Board because of reports of serious adverse events, related to allergic reactions. Forbes reports that 3,234 people had already been enrolled in the REG1 trial.

Allergic Reactions Halted REG1 Phase 2b Trial

During the phase 2b trial for REG1, allergic reactions caused participant enrollment in one study arm to be halted. According to the European Heart Journal, the reactions were serious and one participant developed tachycardia and had to be cardioverted back to a normal heart rhythm. No further participants were recruited for this study arm.

REG1 Side Effects Seen In Clinical Trials

Many adverse events have been reported during the five complete clinical trials conducted for REG1, including:

  • Transient Encephalopathy
  • Minor Bleeding
  • Cutaneous Reactions(rash)
  • Blood in Stool
  • Allergic-like Reactions
  • Major Gastrointestinal Bleeding
  • Major Bleeding
  • Nausea
  • Dyspnoea (shortness of breath)
  • Pruritus
  • Urticaria (hives)
  • Tachycardia
REG1 Trials : Locations and Participant Numbers

REG1 has been tested in six clinical trials, the last two trials have been halted or partially halted, at medical centers around the country.

  • Phase 1a : 85 participants in Bethesda, MD (June-October 2005)
  • Phase 1b : 50 participants at seven sites (April 2006- March 2007)
    • Anchorage, AK; Rapid City, SD; Lexington, KY; Hershey, PN; Houston, TX; New York City, NY; Atlanta, GA
  • Phase 1c : 39 participants at one site
  • Phase 2a : 26 participants at five locations (October 2007 – October 2008)
    • Indianapolis, IN; Detroit, MI; Chapel Hill, NC; Danville, PN; Rapid City, SD
  • Phase 2b : 640 participants at 26 locations (September 2009 – November 2010)
    • Huntsville, AL; Sacramento, CA; San Diego, CA; Clearwater, FL; Gainsville, FL; Fort Lauderdale, FL; Jacksonville, FL; Gainesville, GA; Boise, ID; Meridian, ID; Chicago, Il; Indianapolis, In; Houma, La; Baltimore, MD; Detroit, MI; Buffalo, NY; Chapel Hill, NC; Cincinnati, OH; Philadelphia, PN; Rapid City, SD; Cypress, TX; Seattle, WA; Spokane, WA; Milwaukee, WI
  • Phase 3 : 3,234 participants, enrolled before trial halted, (September 2013 – present)

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