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Accurexa Announces Positive FDA Meeting Outcome.

Roland Rick Perry

Roland Rick Perry,

FULL BIO


The last time we visited Accurexa (ACXA) the shares were trading at $0.44. Within a week of our updating coverage, the shares leapt to near $5.00 and near simultaneously, announced a $2.25 million financing with the two Sabby Capital Healthcare funds, using a conversion price of $1.25, via HC Wainwrighta Nasdaq member firm.

Sabbyhas over $700 million in assets under management.

Theshares have traded with considerable volatility since then, ebbing and flowing with reported news and are now trading just under $1.00 and a tiny $7 million market cap. We believethis offers a potentially rewarding entry point for speculative investors,waiting for an eventual (hoped for) approval of ACX-31 for the treatment ofbrain tumors.

Accurexa's ACX-31 program has been developed incollaboration with Prof. Henry Brem who built one of the largest brain tumorresearch and treatment centers in the world at Johns Hopkins University.

A month ago the company released news of a positive outcome with regards to a pre-IND (Investigational New Drug) meeting request for its ACX-31 program. This is for the local delivery of temozolomidea's adjunctive therapy to BCNU, both chemotherapeutics, in the treatment oftumors in conjunction with surgery and radiation.

Before oral temozolomide became generic, itgenerated US sales of approximately $420 million and global sales ofapproximately $910 million under its brand name Temodar in 2012. However, current standard of care of deliveringtemozolomide to tumor sites through oral administration is limited, by the blood-brain-barrier though oraltemozolomide increases patient survival by 2.5 months, from a 12.1 monthsmedian overall survival.

TheACX-31 program by contrast is focused on developing novel neurological therapies to be directly delivered into specific regions of the brain versusorally.

The FDA confirmed the acceptability of a 505(b)(2) applicationpathway with one first-in-human Phase 2 clinical trial followed by one Phase 3clinical trial. 505 means the Company can rely on studies of previously approved drugs that were not conducted by theCompany.

Weremain of the opinion that if their Phase 2 trial demonstrates tolerability andsuggests activity, that the FDA would encourage Accurexa to request anEnd-of-Phase 2 meeting to discuss the design of an adequate and well-controlled, randomized Phase 3 trial that the share price could ratherquickly exceed its earlier high of $5.00 on June 15th of 2015.

Recent news of note:

In early September (2015), they announced that Professor Robert Langer is the David H. Koch Institute Professor at the Massachusetts Institute of Technology ("MIT") agreedto advise the Company in the development of its ACX-31 Program. The Brem/Langerteam is a force unimagined.

He served as a member of the United States Food and Drug Administration's SCIENCE Board,the FDA's highest advisory board, from 1995-2002 and as its Chairman from 19992002. Hello !

Dr.Langer has written over 1,300 articles. He also has over 1,080 patents worldwide.Dr. Langer's patents have been licensed or sublicensed to over 300 pharmaceutical, chemical, biotechnology and medical device companies. He is the most cited engineer in history (h-index 213). Double hello !!

On September 7th of this year, they announced that Delmar Pharmaceuticals (NASDAQ: DMPI - $57 million marketcap) would collaborate to develop a novel formulation for the local delivery ofcombination chemotherapy for the treatment of brain cancer and other solid tumors.

Underthe terms of the collaboration agreement DelMar will supply VAL-083(dianhydrogalactitol) to be formulated within Accurexa's proprietary ACX-31implantable polymer wafer to locally deliver VAL-083 in combination withtemozolomide and/or BCNU for the treatment of brain cancer.

On October 17th of this year, they announced today a collaboration with StemImmune Inc. ("StemImmune") to develop its stem cell-mediated immunotherapy for the treatment of cancer, such as brain cancer. StemImmune's immunotherapy uses the stealth anti-cancer payload carrying and tumor seeking capacities of a patient's own readily available(adult) stem cells to target cancer. The patient's immune system cannot recognize and react to the "Trojan Horse" stem cells, because they are the patient's own.

Todate, StemImmune has treated 25 cancer patients with its proprietary technologyin a Phase 1 clinical trial that showed that its stem cell-mediatedimmunotherapy was safe and well-tolerated with no adverse events reported, and demonstrated potential anti-tumor activity which supports further investigation in clinical trials. All patients received treatment through a minimallyinvasive outpatient procedure.

"Eradicating cancer and giving patients the ability to undergo lifesaving treatment with no debilitating side effects is what drives our research. Combining our patented technology with Accurexa's proprietary methods of delivering targeted therapies to specific areas of the brain makes Accurexa a valuable partner for us as we pursue the eradication of cancer," said Aladar Szalay, PhD, Founder, CEOand Chairman of StemImmune. "We look forward to a long and productive relationship with Accurexa."

This is an interesting speculative play at with a market valuation under $10 million, to say the least.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

INSTITUITONAL ANALYST INC. 
 NY - CHICAGO - BEVERLY HILLS
ROLAND RICK PERRY, EDITOR.

BiotechStockReview@gmail.com
310-594-8062

Past performance of other companiesadded to Institutional Analysts various newsletters or otherwise mentioned inits research reports, newsletters or communication is no indication of future performanceof any current of future companies mentioned. This publication is a CorporateProfile on behalf of Accurexa (ACXA) Inc. and may not be construed asinvestment advice. This profile does not provide an analysis of the Companysfinancial position and is not a solicitation to purchase or sell securities ofthe Company. Readers should consult their own financial advisors with respectto investment in this or any company covered by the Reviews. An independentfinancial analyst should verify all of the information contained in thisprofile with the profiled company. Institutional Analyst, Inc. the parentcompany of the Alternative Energy and Internet Stock Review is an investmentresearch and public relations firm, which has been compensated by ACXA forinvestor and public relations services including but not limited to this report.Institutional Analyst, Inc., or principals of, has entered into a contract withACXA and has been compensated with fifty thousand restricted shares and twenty fivehundred dollars a month. In preparing this profile, the Publisher has reliedupon information received from the company, which although believed to bereliable, cannot be guaranteed. This profile is not an endorsement of theshares of the company by the publisher. The publisher is not responsible forany claims made by the company. You should independently investigate and fullyunderstand all risks before investing in this and any company profiled orcovered by the publisher. The majority of companies listed on the OTC BulletinBoard have factors, which create an uncertainty about their ability to continueas a going concern. These concerns are typically related to financing (or lackof), competitive environments, lack of operating history and operating at losslevels which is typical of most start-ups. These statements can be found intheir most recent 10Q filings and should most definitely be read. Safe HarborStatement under the Private Securities Litigation Reform Act of 1995: Thestatements which are not historical facts contained in this profile are forwardlooking statements that involve certain risks and uncertainties including butnot limited to risks associated with the uncertainty of future financialresults, additional financing requirements, development of new products orservices, government approval processes, the impact of competitive products orpricing, technological changes, the effect of economic conditions and otheruncertainties detailed in the Companys filings with the securities andExchange Commission. Email: roland@institutionalanalyst.com

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