Heading down the path in search of a Special Protocol Assessment (SPA) from the Food and Drug Administration, Provectus Pharmaceuticals (OTCBB:PVCT), a biotech specialized in developing oncology and dermatology therapies, has received guidance from the FDA to submit its Phase 3 protocol for review.  After several Read More

CorMedix (AMEX: CRMD; Stock Twits: $CRMD) announced that it received a Special Protocol Assessment approval letter from the FDA on the design of a pivotal Phase 3 trial for Deferiprone. Deferiprone is indicated for Contrast-Induced Acute Kidney Injury.  The “SPA” takes into consideration a modification to the dosing regimen contained in the previously submitted protocol.

CI-AKI, also referred to as Contrast Induced Nephropathy (“CIN”), with its associated morbidity and mortality, each year afflicts about one-third of the approximate 325,000 high risk patients with Chronic Kidney Disease (“CKD”) in the U.S. who undergo angiography for vascular imaging. If effective, CRMD001 treatment could significantly reduce the occurrence of CIN and its complications.

A Special Protocol Assessment (SPA) is considered a binding written agreement with the review division of FDA that the sponsor’s proposed trial protocol design, clinical endpoints and statistical analyses are acceptable to support regulatory approval. Final marketing approval depends on results of the study and an evaluation of the benefit/risk of a treatment.

The Phase 3 clinical study of CRMD001 to be conducted under the SPA is planned for approximately 800 patients in approximately 80 centers worldwide. The planned study will be randomized, double-blind and placebo-controlled, with patients evenly divided into two groups: CRMD001 and placebo. The study will assess the efficacy and safety of CRMD001, or Deferiprone, in the reduction of morbidity and mortality in patients with CKD undergoing diagnostic or interventional cardiac procedures and receiving an iodinated radiocontrast agent. The study will have a primary composite clinical endpoint that includes: death, dialysis, myocardial infarction, stroke, congestive heart failure and hospitalization. The hypothesis is that CRMD001 will significantly reduce the composite event rate compared to placebo. The study also includes secondary and exploratory endpoints which will include changes in serum creatinine and serum cystatin C, as well as other biomarkers. CRMD01 or placebo will be administered orally for 8 days.

Mark Klausner, M.D. CorMedix Chief Medical Officer commented in the press release:

“Receiving the SPA Agreement letter from the FDA represents a significant milestone for the company, and further solidifies our planned pivotal Phase 3 study for CRMD001. If approved by the FDA, CRMD001 would be the first orally administered therapeutic on the market for the prevention of CIN.”

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As Phase III trials continue to advance, Keryx Biopharmaceuticals (NASDAQ:KERX, StockTwits: $KERX) is finding itself the subject of analyst reports and articles penned by biotech writers.  Recently, an article on Street Insider noted an Oppenheimer’s Boris Peaker initiating coverage on Keryx with an “outperform” rating and a $7 price target.

Seeking Alpha biotech contributor VFC’s Stock House also authored an article explaining an expected rise in shares of KERX as clinical trials head towards conclusion.  VFC also remarked on MLV Capital initiating coverage on Keryx this month with a “Buy” rating.  Concluding the article, the author stated,

“For the time being, I still see a push higher leading into Phase III results, especially with the stock receiving the additional attention of the recent analyst coverage.”

Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with approved therapies. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 studies is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is also developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex for the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease on dialysis is being conducted pursuant to an SPA agreement with the FDA. Keryx is headquartered in New York City.

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