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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

 


 

 

ACXA
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ACXA News: Amended Statement of Beneficial Ownership (sc 13d/a) 06/12/2017 01:47:24 PM
ACXA News: Statement of Changes in Beneficial Ownership (4) 06/12/2017 12:52:34 PM
ACXA News: Current Report Filing (8-k) 06/09/2017 12:57:44 PM
ACXA News: Initial Statement of Beneficial Ownership (3) 05/30/2017 01:14:53 PM
ACXA News: Statement of Beneficial Ownership (sc 13d) 05/26/2017 05:15:33 PM
PostSubject
#1120   Thanks. Will do. shanak10 06/12/17 03:28:50 PM
#1119   Read the 8k funnyG986 06/12/17 03:26:43 PM
#1118   Look at the code on the Form 4 shanak10 06/12/17 03:26:09 PM
#1117   Not award. Read the 8k funnyG986 06/12/17 03:24:33 PM
#1116   The purpose of the transaction and First License ktcougar 06/12/17 02:38:39 PM
#1115   That form 4 is not a purchase but shanak10 06/12/17 02:25:19 PM
#1114   13D/A out. shanak10 06/12/17 02:06:50 PM
#1113   That's tied in to the 8k that was ktcougar 06/12/17 01:38:51 PM
#1112   Nice form 4 MADDSTACKER 06/12/17 01:22:49 PM
#1111   ACXA is not typical ihub play funnyG986 06/12/17 01:03:38 PM
#1110   ACXA FORM 4 showing shares acquired at $0.2 funnyG986 06/12/17 01:01:26 PM
#1109   Cant get volume... HallaDurg 06/12/17 01:00:26 PM
#1108   ACXA FORM 4 out funnyG986 06/12/17 12:59:55 PM
#1107   Only 1.4M shares in DTC. All other shares funnyG986 06/10/17 11:18:42 AM
#1106   How does the 30 million share figure into vp_007_99 06/10/17 02:04:26 AM
#1105   Lets go $ACXA MrCheap 06/09/17 02:25:56 PM
#1104   Agreed bought some .20 last week ... Assuming we MADDSTACKER 06/09/17 01:28:09 PM
#1103   The potential of this is crazy. Just Grolden 06/09/17 01:27:12 PM
#1102   Looking good :) MADDSTACKER 06/09/17 01:26:12 PM
#1101   Added a few here for the long haul. Grolden 06/09/17 01:25:49 PM
#1100   Wow...I knew it was low but not that ktcougar 06/08/17 12:18:44 PM
#1099   Omg MADDSTACKER 06/08/17 09:24:22 AM
#1098   ACXA only 1.47M shares held at DTC. I funnyG986 06/07/17 10:26:51 PM
#1097   Agreed , they been moving along with filings MADDSTACKER 06/01/17 10:50:59 AM
#1096   Should hear something by next week I would think! ktcougar 06/01/17 10:50:15 AM
#1095   Ready for update .... :) MADDSTACKER 06/01/17 10:47:23 AM
#1094   Humm .20's available....didn't think I would see those ktcougar 06/01/17 10:45:56 AM
#1093   Wonder if there going to buy it MADDSTACKER 05/27/17 02:04:45 PM
#1092   Looks like they taking share count seriously ... Could MADDSTACKER 05/27/17 02:03:47 PM
#1091   The owner of the 10M shares is the funnyG986 05/27/17 01:58:43 PM
#1090   Wouldnt mind slapping some to avg down myself HallaDurg 05/27/17 12:22:24 PM
#1089   Great, holding tight think we might see buyers HallaDurg 05/27/17 12:22:05 PM
#1088   Filing out looks like deal is done . MADDSTACKER 05/26/17 09:13:06 PM
#1087   Someone just flipping for pennies imho .... I think MADDSTACKER 05/23/17 01:41:51 PM
#1086   Me too disappointed in the drop but should HallaDurg 05/23/17 01:40:21 PM
#1085   I'm still in :) Let's gooo drop that MADDSTACKER 05/23/17 01:16:04 PM
#1084   Anyone home :) MADDSTACKER 05/19/17 12:12:03 PM
#1083   Waz up HD :) MADDSTACKER 05/18/17 12:54:20 PM
#1082   ACXA lets see how high this one goes! HallaDurg 05/18/17 12:26:50 PM
#1081   I'm ready !!! Let's goooooo MADDSTACKER 05/18/17 11:46:30 AM
#1080   ACXA 0.3 X 0.35 breakout coming now funnyG986 05/18/17 11:46:09 AM
#1079   ACXA 0.3; 0.35 NEXT moving on air funnyG986 05/18/17 11:38:51 AM
#1078   Maybe .35 in the afternoon ? MADDSTACKER 05/18/17 11:33:37 AM
#1077   3 filings in 1 day , I'm sure MADDSTACKER 05/18/17 10:40:44 AM
#1076   ACXA once break 0.35, next resistance is 0.8 area funnyG986 05/18/17 10:29:24 AM
#1075   I'm ready up 40% on 21 k volume MADDSTACKER 05/18/17 10:19:05 AM
#1074   ACXA 0.28. easy mover back to 0.5+ funnyG986 05/18/17 10:17:58 AM
#1073   ACXA 22% OS holding (around 4M shares ) funnyG986 05/18/17 10:08:10 AM
#1072   Might have to consider grabbing a piece of MERCURIAL 05/18/17 10:04:41 AM
#1071   Company is huge , they work with MAYO MADDSTACKER 05/18/17 09:59:20 AM
PostSubject