VTL Plunges As Trial Flops, NWBO Sets It Straight, Court Rules In Favor Of MDXG

(RTTNews) - HedgePath Pharmaceuticals Inc. (HPPI.OB) has commenced enrollment in its phase II(b) study of SUBA-Itraconazole for treatment of basal cell carcinoma in patients with basal cell carcinoma nevus syndrome, also known as Gorlin's Syndrome.

The company plans to recruit up to 40 patients across three clinical trial sites in the U.S., and expects to be able to assess interim results in over half of these patients during the first quarter of 2016.

HPPI.OB closed Friday's trading at $0.13, up 18.18%.

MiMedx Group Inc. (MDXG) has received a favorable ruling in patent infringement lawsuits related to its flagship brands, EpiFix and AmnioFix.

AmnioFix and EpiFix, processed from human amniotic membrane that is derived from donated placentas, serve to regenerate damaged or diseased tissues by delivering human extracellular matrix components, essential growth factors, and specialized mediating cytokines.

Patent infringement lawsuits were filed against Liventa Bioscience Inc., Medline Industries, Inc. and Musculoskeletal Transplant Foundation, Inc. by MiMedx in April 2014 for permanent injunctive relief and unspecified damages, and in the following month of that year, a separate action was filed against Transplant Technology, Inc. d/b/a Bone Bank Allograft and Texas Human Biologics Ltd. for patent infringement.

MDXG closed Friday's trading at $9.16, up 5.17%.

Shares of Northwest Biotherapeutics (NWBO) were down more than 21% on Friday as news broke that in the EU Clinical Trials Register, the company's phase III trial of DCVax-L for the treatment of brain cancer was listed as having been temporarily halted in Germany.

However, the company has clarified that the trial is ongoing and the patients enrolled in the trial are continuing to be treated per the protocol. Over 300 patients have been recruited for the trial. The total anticipated enrollment is 348 patients.

It is only the new screening of patient candidates for the trial that has been temporarily suspended, noted the company. The company has sought to have the European Clinical Trials Database listing corrected.

NWBO closed Friday's trading at $6.96, down 21.62%. In after-hours, the stock was up 5.60% at $7.35.

Seres Therapeutics Inc.'s (MCRB) investigational drug SER-109, an oral therapeutic, currently in a phase II clinical trial for the prevention of recurrent Clostridium difficile infection (CDI) in adults, has been granted orphan drug designation by the FDA.

The company expects results from this study to be available in the middle of 2016.

Seres went public as recently as June 26, 2015 offering its shares at a price of $18.00 each.

MCRB closed Friday's trading 3.23% higher at $40.56.

TiGenix NV's (TGXSF.PK) lead compound Cx601 has met the primary endpoint in a phase III study, dubbed ADMIRE-CD, in Crohn's disease patients with complex perianal fistulas.

According to the study results, a single injection of Cx601 was statistically superior to placebo in achieving combined remission at week 24, in patients with inadequate response to previous therapies, including anti-TNFs.

TIB.BR closed Friday's trading at 0.71 EUR, down 0.83%.

Shares of Vital Therapies Inc. (VTL) plunged over 75% in extended trading on Friday as the company's phase III trial evaluating its ELAD System in subjects with alcohol-induced liver decompensation, dubbed VTI-208, failed to meet the primary endpoint of overall survival.

ELAD is an investigational extracorporeal, human cell-based liver support system designed with the proposed intent to supplement hepatic function in order to improve survival rates among subjects with liver failure.

Following the failure of the VTI-208 study, a phase III study of ELAD intended to support potential European Medicines Agency approval in severe acute alcoholic hepatitis, known as VTI-210 and a phase II study that is part of a phase II / III clinical program of ELAD in subjects with either fulminant hepatic failure and surgery induced liver failure, dubbed VTI-212, which are recruiting participants, will be stopped.

In light of the pre-specified exploratory subset analyses of the VTI-208 trial suggesting efficacy trends, the company plans to meet with the FDA as soon as possible to discuss restructuring its clinical development program, including a potential new trial to confirm the information suggested by the subset analyses.

VTL closed Friday's trading at $17.68, up 10.02%. In after-hours, the stock was down 75.11% to $4.40.