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Accurexa Inc. (ACXA)

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Accurexa Inc.

ACXA

Accurexa is a biotechnology company focused on developing novel neurological therapies to be directly delivered into specific regions of the brain. We are developing our ACX-31 program to deliver two chemotherapy drugs, temozolomide in combination with BCNU, locally to brain tumor sites. Our ACX-31 program is based on an issued patent licensed from Accelerating Combination Therapies LLC which is co-owned by Prof. Henry Brem, Director of the Neurosurgery Department at Johns Hopkins University. We are collaborating in the development of our ACX-31 program with Prof. Henry Brem who built one of the largest brain tumor research and treatment centers in the world at Johns Hopkins University. Prof. Robert Langer, who is the David H. Koch Institute Professor at MIT and the most cited engineer in history, is also advising us in the development of our ACX-31 program. We engaged the Yissum Research Development Company of The Hebrew University of Jerusalem Ltd. ("Yissum") to develop and supply polymeric formulations of a combination of temozolomide and BCNU. Professor Avi Domb leads the development efforts provided by Yissum. Prof. Brem, Prof. Langer and Prof. Domb are pioneers in the development of local drug delivery treatments, and invented and developed Gliadel® (carmustine implant) which is a FDA approved, local chemotherapy for the treatment of glioblastoma multiforme.

 

Oral temozolomide is a generic, FDA approved, first-line chemotherapy drug that is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. Before oral temozolomide became generic, it generated US sales of approximately $420 million and global sales of approximately $910 million under its brand name Temodar® in 2012. However, current standard of care of delivering temozolomide to tumor sites through oral administration is limited by the blood-brain-barrier and oral temozolomide increases patient survival by 2.5 months from a 12.1 months median overall survival.

Animal studies at the Johns Hopkins School of Medicine[1] have shown that local delivery of temozolomide increased concentrations of the drug in the brain threefold and increased survival up to fourfold compared with oral administration. The percentage of long-term survivors for groups receiving local delivery of temozolomide ranged from 25% to 37.5% while there were no long-term survivors with orally administered temozolomide. Further animal studies at the Johns Hopkins School of Medicine[2] have shown that the additive effect of combined delivery of local temozolomide with local BCNU, especially in combination with radiotherapy, was significantly more effective than delivery of either drug alone or one systemically and one locally, either with or without radiation. Groups treated with combination of local temozolomide, local BCNU and radiation therapy had 75% long-term survivors.

 

Our BranchPoint device was invented to deliver multiple therapeutics, such as stem cells, chemotherapy or gene therapy vectors, through the radial deployment of a flexible catheter to specific brain target areas through a single brain penetration, and was licensed from UCSF (University of California, San Francisco). The current standard of care is the use of straight, rigid needles, often requiring surgeons to penetrate the brain multiple times for delivering therapeutics, which in turn may increase the risk of bleeding, stroke and reflux of therapeutics back out to the brain surface. An animal study at UCSF[3] demonstrated that the use of a straight needle was associated with reflux of at least 75% of the infusion while no reflux was found with our BranchPoint device. The development of the BranchPoint device was originally funded with $1.8 million by California's Stem Cell Agency CIRM (California Institute of Regenerative Medicine). ?
 

Our Pipeline

Fig. 2:  Immunohistochemistry analysis of dopaminergic neural stem cells grafted to the pig striatum:               (d) 4'-6-diamidino-2-phenylindole nuclear stain

            (e) STEM 121-positive cells at the graft site

            (f) Green Fluorescent Protein-positive cells at the graft site

            (g) Merged images showing the border between graft-derived cells and pig striatum

 

Fig. 1:  BranchPoint allows delivery of multiple therapeutics

 

Effective and safe delivery of therapeutics directly to the brain is often limited by the blood-brain barrier. We are currently developing two programs in our pipeline.  

 

1. ACX-31 for the local delivery of chemotherapy to brain tumors:

  • ACX-31 could deliver local temozolomide in combination with local BCNU to brain tumor sites.  

    Temozolomide is a generic, approved chemotherapy drug that is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.  Before temozolomide became generic, it generated US sales of $420 million and global sales of $910 million under its brand name Temodar® in 2012.
    BCNU (carmustine) is another chemotherapy drug that is contained in Gliadel®, a biodegradable polymer that is implanted locally into the resection cavity after surgical removal of a brain tumor and is indicated for the treatment of newly diagnosed and recurrent glioblastoma multiforme.

    ?Glioblastoma multiforme is one of the most aggressive brain cancer types – approx. 22,000 patients are newly diagnosed and 15,000 patients die each year in the US. Median survival without treatment is 4.5 months. With treatment, concomitant and adjuvant temozolomide chemotherapy with radiation improves, from 12.1 months to 14.6 months, progression free survival and overall survival in glioblastoma patients, as demonstrated in recent randomized clinical trials.  ?

 

2. BranchPoint device for the local delivery of therapeutics, such as stem cells or gene therapy:?

  • ?We filed a 510(k) submission of our BranchPoint device to the FDA in June 2015.  

    Our BranchPoint device is a single platform that may allow accurate, anatomic targeting of intended brain sites and the delivery of multiple novel therapeutics under "real-time" MRI guidance (Fig. 1).

    ?The feasibility of delivering human dopaminergic neural stem cells for the treatment of Parkinson's Disease has been demonstrated in animal studies (Fig.
     

Fig. 2:  Immunohistochemistry analysis of dopaminergic neural stem cells grafted to the pig striatum:               (d) 4'-6-diamidino-2-phenylindole nuclear stain

            (e) STEM 121-positive cells at the graft site

            (f) Green Fluorescent Protein-positive cells at the graft site

            (g) Merged images showing the border between graft-derived cells and pig striatum

Our BranchPoint Device

Our BranchPoint device can deliver therapeutics through the radial deployment of a flexible delivery catheter to large and anatomically complex brain targets through a single initial brain penetration. Clinicians can "tailor" thera-peutic delivery to individual patient anatomy and specific disease targets, which may enhance the efficacy of therapies.  Our BranchPoint device may also give physicians more precise control of the volume of therapeutics delivered and ensure that therapeutics delivered into the brain stay in the brain, avoiding the problem of reflux out to the brain surface. This modern and "easy to use" technology may allow "real-time" monitoring of therapeutic delivery under interventional MRI guidance (iMRI), which could improve the accuracy of therapeutic delivery, reduce the risk of complications, and increase patient safety.

?

Currently available neurosurgical devices can deliver a straight, rigid needle to single brain locations. However, this basic strategy limits the size and "shape" of the brain treatment area. In order to deliver to larger and more complex brain targets, the surgeon needs to penetrate the brain multiple times with such straight needles, which may increase the risk of bleeding and stroke, and may reduce the efficacy of therapeutics due to reflux, whereby therapeutics injected using straight needles can flow back out to the brain surface along the needle's path.

 

Fig. 3:  Deployment of flexible delivery catheter with intuitive, simple controls


Stock Quote:  OTCQX:ACXA

 

Company Presentation:  March 2016

 

??Regulatory Filings:  SEC Filings

 

Form 10-Q - June 30, 2016 - XBRL

Form 10-Q - March 31, 2016 - XBRL

Form 10-K - December 31, 2015 - XBRL

Form 10-Q - September 30, 2015 - XBRL

Form 10-Q - June 30, 2015 - XBRL?

 

Press Releases:

 

BranchPoint Device Publication:

MRI guides cell transplants to the brain - Molecular Therapy Article - January 2015

 

Contact Info
  • 113 Barksdale
    Newark, DE 19711
 
ACXA Security Details
Share Structure
  Market Value1 $6,550,512 a/o Sep 28, 2016
  Authorized Shares 20,000,000 a/o Aug 12, 2016
  Outstanding Shares 9,180,816 a/o Aug 12, 2016
  -Restricted Not Available
  -Unrestricted Not Available
  Held at DTC Not Available
  Float 1,557,000 a/o Apr 12, 2016

 


 

 

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ACXA
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ACXA News: Quarterly Report (10-q) 11/04/2016 10:37:47 AM
ACXA News: Current Report Filing (8-k) 10/14/2016 12:24:15 PM
ACXA News: Quarterly Report (10-q) 08/12/2016 03:21:52 PM
ACXA News: Current Report Filing (8-k) 07/22/2016 02:51:53 PM
ACXA News: Quarterly Report (10-q) 05/12/2016 01:18:16 PM
PostSubject
#1055   This company has some possibilities but the notes vp_007_99 10/14/16 08:38:38 PM
#1054   I agree with you there.. They will be Prince Goro 10/11/16 03:21:13 PM
#1053   Check out this nice Collaboration between DMPI and ACXA Prince Goro 10/11/16 03:19:25 PM
#1052   Company Presentation ~ Accurexa, Inc. zigzagman 10/11/16 02:21:21 PM
#1051   I agree my friend with volume this one Cabroncita 10/11/16 02:03:29 PM
#1050   If it can break above resistance at .84 zigzagman 10/11/16 11:04:05 AM
#1049   It looks like ACXA can come alive here Prince Goro 10/11/16 10:28:25 AM
#1048   The chart does look good Zig! Cabroncita 10/11/16 10:04:04 AM
#1047   Nice looking chart here Cabi! zigzagman 10/11/16 09:13:05 AM
#1046   The Company is focused on developing novel neurological Cabroncita 10/11/16 09:09:32 AM
#1045   Take a look at the Key Stats for Cabroncita 10/06/16 03:25:50 PM
#1044   Volatility is increasing here on ACXA. Let's Prince Goro 10/06/16 02:04:36 PM
#1043   About ACXA's partner DelMar Pharmaceuticals, Inc. (Nasdaq - DMPI) zigzagman 10/06/16 01:26:22 PM
#1042   $1.00 just hit for 100 shares! Above Cabroncita 10/06/16 12:54:43 PM
#1041   good to see some action here. I am Prince Goro 10/06/16 12:46:40 PM
#1040   +5.88 at the .90 HOD and asking for zigzagman 10/06/16 11:39:34 AM
#1039   I am looking forward to it too! Cabroncita 10/06/16 11:27:10 AM
#1038   just got done doing some deep DD on Prince Goro 10/06/16 11:03:58 AM
#1037   Have you seen this interview with the CEO zigzagman 10/06/16 10:21:23 AM
#1036   The Company is focused on developing novel neurological Cabroncita 10/06/16 10:10:26 AM
#1035   This one looks like an up and coming Prince Goro 10/06/16 09:46:40 AM
#1034   DelMar Pharmaceuticals (Nasdaq - DMPI) and Accurexa to zigzagman 10/06/16 09:38:15 AM
#1033   Dont miss this interview with ACXA guys.. "NEW Prince Goro 10/06/16 09:20:57 AM
#1032   Barchart.com upgraded the daily chart to a 80% zigzagman 10/06/16 09:11:50 AM
#1031   This interview is going to be huge..want to Cabroncita 10/06/16 09:08:45 AM
#1030   hey guys good morning. This is looking Prince Goro 10/06/16 08:41:18 AM
#1029   56% Strong Buy rating on the daily chart zigzagman 10/05/16 03:54:16 PM
#1028   looking very interesting here. I just did some Prince Goro 10/05/16 03:43:48 PM
#1027   The daily chart is forming a Bullish Cup zigzagman 10/05/16 03:24:32 PM
#1026   Check out the information on this link, great information: Cabroncita 10/05/16 03:22:11 PM
#1025   That it is my friend I am Cabroncita 10/05/16 03:18:01 PM
#1024   ACXA slowly been going up stockseekerok 10/05/16 10:30:07 AM
#1023   "NEW TO THE STREET's" October Line-Up Broadcast on stockseekerok 10/03/16 02:38:11 PM
#1022   Hmm glad to hear that in a way, stockseekerok 09/29/16 07:44:37 AM
#1021   There is a stock promoter making phone calls MADECASHONHMGP 09/27/16 05:32:26 PM
#1020   ACXA chart stockseekerok 09/27/16 02:55:10 PM
#1019   ACXA up 20 % @ .75 light volume stockseekerok 09/27/16 11:02:49 AM
#1018   ACXA Security Details stockseekerok 09/26/16 04:35:37 PM
#1017   We wait TRADER122 05/31/16 04:07:44 PM
#1016   <<The convertible preferred stock is convertible into shares tedpeele 01/12/16 07:21:07 PM
#1015   The Chances of Surviving Brain Cancer are Minimal. Roland Rick Perry 10/29/15 02:17:51 PM
#1014   How long it takes the FDA to "approve" Roland Rick Perry 10/28/15 10:40:30 AM
#1013   Dr Henry Brem Roland Rick Perry 08/22/15 08:50:22 AM
#1012   Not familiar with timelines for FDA approval, maybe Doubloon 08/12/15 09:24:47 AM
#1011   when do you expect the FDA approval? Gigi70 08/12/15 08:49:51 AM
#1010   when do you expect the FDA approval? Gigi70 08/12/15 08:46:14 AM
#1009   follow the story not the share price, wait Doubloon 07/21/15 03:08:02 PM
#1008   I just recently bought some shares of Accurexa.....being candleshopper 07/21/15 10:19:10 AM
#1007   Welcome Sabby Capital Management as New Shareholder. Roland Rick Perry 07/20/15 11:36:34 AM
#1006   Election of Director Doubloon 07/02/15 12:04:42 PM
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