Latest Orphan Drug Designations for Developing Therapies for Rare Diseases Target New Treatments for Various Cancer Conditions - Biotech Company Reaches Two Major Milestones

Aug 13, 2015, 08:45 ET from FN Media Group LLC

CORAL SPRINGS, Florida, August 13, 2015 /PRNewswire/ --

Industry analysts still point to possible forecast the Biotech sector remains a top performer - not only for 2015, but is projected over several years at this point to improve as biopharmaceutical companies forge ahead developing the newest treatments for diseases, cancer drug therapies and array of illnesses.  For cancer patients alone, more than 22,000 new cases of brain cancer were expected to arise in Americans in 2015, according to the National Cancer Institute, which continues to be a focus for many biotech companies.  Biotech Companies active with current news and developments include Nascent Biotech, Inc. (OTC: NBIO), Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), Echo Therapeutics, Inc. (NASDAQ: ECTE), Amedica Corporation (NASDAQ: AMDA) and Advaxis, Inc. (NASDAQ: ADXS)

Since March of 2014 Nascent Biotech, Inc. (OTC:NBIO) has raised $2.1 million which has been used to advance the development of their core product, Pritumumab, for eventual filing of an Investigation New Drug exemption (IND).  Pritumumab is a human monoclonal antibody that is being developed for the treatment of malignant and non malignant Gliomas.  One of the biggest challenges in the development of any antibody product is to show that it can be manufactured at appropriate scale, to clinical grade and in sufficient quantity for human trials.  "We have completed this and manufactured more than enough product to complete our initial Phase 1/Phase 2 human trials on Brain Cancer with more than adequate amounts left over to initiate trials in other epithelial cancers such as colon and pancreas."  

Read the full NBIO Press Release at http://www.financialnewsmedia.com/profiles/nbio.html

An additional challenge is to understand the toxicity profile.  "We have completed a toxicology study in compliance with FDA guidance, and we have demonstrated no toxicity in the two species studied (Monkey and Rat).   Another significant milestone worth noting is that the FDA granted Nascent Biotech an Orphan Drug Designation for Gliomas (brain cancer). This will give us market exclusivity for a period of 7 years after the drug is approved," says Nascent President Sean Carrick.

In other Biotech news and market activity of note:  Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, announced dose administration for the first patients in a Phase 3 study of EBI-005 for the treatment of moderate to severe allergic conjunctivitis. This Phase 3 study was designed and initiated following the completion in October 2014 of a Phase 2 study in which EBI-005 exhibited biological activity in improving the symptoms of late-phase allergic responses in patients with moderate to severe allergic conjunctivitis. This included statistically significant improvements in mean change from baseline in patient reported ocular itching, tearing and associated nasal symptoms compared to vehicle-control at the second to last and final assessment time points following allergen exposure in a modified direct conjunctival allergen provocation test (CAPT) model.

Echo Therapeutics, Inc. (NASDAQ: ECTE), a medical device company focused on non-invasive continuous glucose monitoring (CGM) and associated technologies, recently announced that, after numerous consultations with the Chinese government, its strategic partner, Medical Technologies Innovation Asia (MTIA), Ltd., believes that Echo's locally produced needle-free CGM products will be designated as a Class 2 medical device. Class 2 medical devices have a review period of 90 working days after filing submission with the Medical Device Evaluation Center of the China Food and Drug Administration (CFDA).  A formal and final designation from the CFDA is determined only at the time of submission.

Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial company which develops and manufactures silicon nitride as a platform for biomedical applications, is pleased to announce Agência Nacional de Vigilância Sanitária (ANVISA) cleared its first generation Valeo™ silicon nitride interbody fusion devices and instrument sets for use in Brazil.

Advaxis, Inc. (NASDAQ: ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, last week announced two research projects involving the company's Lm Technology(TM) immunotherapy candidate ADXS-PSA, which is being developed for prostate cancer, have been selected as 2015 Movember Foundation-PCF Challenge Awards, sponsored by the Movember Foundation and the Prostate Cancer Foundation (PCF). Grants amounting to $1 million each have been awarded to two ADXS-PSA teams conducting innovative large-scale research projects concerning metastatic, treatment-resistant prostate cancer, an advanced form of the disease with often-lethal outcomes.

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