Immunocellular (IMUC) - Update(s) Phase II trial of ICT-107 for Glioblastoma

ImmunoCellular (OTCBB: IMUC) provided an update on the site and patient enrollment for ICT-107, currently in a Phase II trial for Brain Cancer. Recall that this is a dendritic cell based cancer vaccine targeting multiple tumor antigens for the treatment of glioblastoma multiforme (GBM or brain cancer).

• The company initiated the trial in 23 centers to enroll up to 160-200 patients, (100 with the HLA-A1/A2 immunological subtypes). 115 patients are enrolled in the study to date, ahead of schedule.
• Enrollment for the trial is expected to be completed by Q2 of 2012 and an interim analysis is expected when 50% of events (32 deaths) have been observed.
• NeoStem's, Progenitor Cell Therapy (PCT) is working with Immunocellular on the "manufacturing".

Conclusion: We discussed IMUC last week and we believe that this dendritic approach is showing compelling data in this unmet medical need. PCT (NeoStem) eliminates any manufacturing concerns, (PCT did most of the clinical manufacturing for Dendreon's Provenge). IMUC looks like an attractive play, and the company is financed through to proof of concept, given that capital was raised earlier in January 2012.

See all Daily Dose articles on IMUC.

ImmonoCellular (IMUC) - All Systems are Go !

ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC) presented at the Noble conference in Florida last week, and we attended their presentation. Think of IMUC as Dendrion but this time targeting brain cancer (GlioBlastoma), the same cancer that killed Ted Kennedy. This is absolutely an unmet medical need. A few points to be excited about IMUC:

1. The company has now raised capital, has a modest burn rate and as such is solidly financed to the next data point.
2. Lead product is ICT-107 (dendritic cell for glioblastoma - GBM, or Brain Cancer), and the Phase II trial has started.
3. The Phase 1 data looks pretty remarkable. Average survival in these patients is typically about 15 months. In the Phase 1 trial IMUC has reported a median over-all survival of 38.4 months.
4. Attractive valuation: $45 mln market cap, plenty of cash, Phase II trials underway, and proof of concept data in the P1 trial as well as the therapeutic area (dendritic cell approach, aka :Dendrion).

See all Daily Dose articles on IMUC.

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WBB Upgrades NeoStem ($NBS), Target = $2.00

WBB Securities upgraded NeoStem (NASDAQ: NBS) to a Buy with a 12 months price target of $2.00 per share. The report cited a few reasons which include:

1. Expansion of the intellectual property associated with Amorcyte beyond STEMI (Heart attacks) to all Vascular Insufficiency.
2. New PCT clients on-board such as Immunocellular (IMUC) - (working on a dendritic cell based approach to brain cancer), and Islet BioSciences (microencapsulated insulin-producing, pathogen free swine (pigs) for type 1 diabetes’s. NeoStem actually gets a royalty on commercial sales (utilizing PCT's manufacturing currency to participate in clients downstream revenues).
   
3. Divestiture of China Generic company (WBB estimates $25 million).
4. The start of the Amorcyte Phase II trial.

Tigenix: Allogenic Cell Therapy for Complex Anal Fistulas, $TIG

Last week at the BioTech showcase Tigenix (NYSE Euronext: TIG) presented as part of a panel of companies talking about auto-immune disease and many possible indications. One that caught our attention was Cx601.

Cx601 is an "EU-medicinal product" based on expanded mesenchymal stem cells obtained from adipose tissue (eASCs). This product is a member of the new generation of cell therapies.

• According to Tigenix: Cx601 is the first medicinal product based on allogeneic (collected from donors) eASCs to be approved for clinical trials worldwide.
• Cx601 is able to activate the physiological repair mechanisms of the body thanks to its capacity to interact with the body.
• Prior clinical trials with eASCs suggest that Cx601 has a great therapeutic potential based on its anti-inflammatory, healing, and immunoregulatory properties.

Cx601 is a suspension for injection that contains donor-derived stem cells isolated and expanded from adipose tissue obtained by liposuction.

Cx601 is being evaluated in a Phase II clinical trial for the treatment of complex perianal fistula in patients with Crohn’s disease. Cellerix estimates that it will be able to start in 2011 the last phase of clinical development before starting the approval process.

A perianal fistula is an abnormal connection between the perianal space and outside skin surface. A fistula is considered to be complex when its treatment involves a high risk of causing loss of anal continence, the fistulous tract crosses more than 30% of external sphincter (high trans-sphincteric, suprasphinctetic, and extrasphincteric), several tracts are found, is recurrent, or patient has incontinence, local irritation, or Crohn’s disease.

Current treatment for complex fistula in patients with Crohn’s disease is poorly effective and costly. Patients with complex fistula but no inflammatory disease require surgery, with its attendant risk of fecal incontinence. We would note that Ventrus (NASDAQ: VTUS) is another company outside of Cell Therapy that is working in this area.

Cx601 acts by controlled reduction of inflammation in the fistula, promoting adequate homeostasis through the release of anti-inflammatory factors which in turn promote natural fistula closure.
Cx601 has been designated as an orphan drug by the European Medicines Evaluation Agency.

Clinical Development: An allogeneic therapy based on eASCs in clinical phase
The program is based on the local administration of allogeneic eASCs for the treatment of complex perianal fistula in patients with Crohn’s disease. Safety of this treatment has been documented by its use for treating patients in a compassionate use program. Designation as an orphan drug for Europe was achieved in a record time.

A Phase I/II, open label study of this product for the indication of complex perianal fistula derived from Crohn’s disease has been done (24 patients across 6 centers). The primary objectives of this study were to :

• To show that administration of allogeneic cells from healthy donors is safe.
• To assess the efficacy of Cx601 in terms of complete closure of complex perianal fistula 12 and 24 weeks after initial drug administration.

Tigenix is now hoping to move this program forward to a pivotal trial. Given the fact that Tigenix has developed ChondroCelect^®, the company’s lead product for cartilage regeneration in the knee we believe this company is worth watching.

Ventrus (VTUS): Hemorrhoid Drug-309- PIIb hits its Primary Endpoint

Last week Ventrus Biosciences (NASDAQ: VTUS) reported that the final results from its PIIb study of VEN 309 (Iferanserin ointment) for the treatment of internal hemorrhoid disease (HD) were published. This study was conducted in Europe (Germany) and was randomized, double-blind, t=14-day placebo-controlled trial evaluating the efficacy and tolerability of BID (twice-daily) VEN 309 for the cessation of bleeding and other symptoms associated with Hemorrhoids.

The study hit its primary endpoint demonstrating efficacy and safety. The primary efficacy endpoints was a severity scores for bleeding on days 7 & 14. Secondary efficacy endpoints were itching, pain and other related symptoms also on day 7 & 14. The study was well powered at n= 111 patients split between control (placebo) and active VEN 309 groups.

VEN 309 was associated with a statisically significant reduction in daily bleeding &  itching on both days seven and 14 (bleeding, p<0.0001 and p=0.0075, respectively; itching, p=0.0008 and p=0.027, respectively). In terms of pain relief the data showed a favorable trend but was not statisically significant. Given that this is a Phase II trial and not a Phase III trial we are not concerned, a larger Phase III (P3 n=600) should add enough pwer to see a significant result. 

VEN 309 is on track to be the first new treatment (FDA Approved) for hemorrhoids. VEN 309 is in a Phase 3 trial now with top-line results expected this spring to summer. 

ARM Panel shines light on the Cell Therapy Cardiovascular Space

This morning in SanFransico the ARM panel on cardiovascular medicine is taking place. NeoStem (Amorcyte), MesoBlast (MSB), Athersys (ATHX) and Cytori (CYTX) are presenting their cell therapy approaches. We will follow up with comments from this panel and the panels that follow throughout the day. In other news NeoStem announced the expansion of their IP for AMR-001 (their CD34+ cell therapy product) beyond STEMI (heart attacks) and to all ischemic (vascular insufficiency) diseases. We looked at the patent and we see this as a landmark expansion in the space. Immunocelluar (IMUC) also had news today, raising capital (aprox $9.4 mln) which will be used to fund the development of their dendritic approach to brain cancer (glioblastoma). We note that IMUC is working with NeoStem's CMO subsidiary, Progenitor Cell Therapy (PCT).

ProActive Capital Resources Group Announces Client Participation at San Francisco Healthcare Conferences

JP Morgan's 30th Annual Healthcare Conference 

5^th Annual OneMedForum San Francisco 2012

Biotech Showcase 2012 in San Francisco

New York, NY, January 9, 2012 – ProActive Capital Resources Group, a strategic corporate communications, investor relations and social media firm today announced that several of its clients will be presenting at three prestigious investor conferences in San Francisco next week. The following companies will be presenting their corporate presentations at JP Morgan's 30th Annual Healthcare Conference, the 5^th Annual OneMedForum San Francisco 2012, and the Biotech Showcase 2012 in San Francisco.

“We are proud to have several of our clients presenting at these quality industry conferences as we continue to grow our healthcare practice at ProActive Capital,” stated Jeff Ramson, CEO of ProActive Capital Resources Group. “These healthcare conferences provide the visibility and help build awareness as our clients continue to execute on their growth initiatives.”

To schedule a one on one meeting with any of the companies please contact us at the number below.

Coronado Biosciences, Inc. (Nasdaq:CNDO), will present at the Biotech Showcase 2012 Conference on Wednesday, January 11, 2012 at 4:30 PM PT.

Ventrus BioSciences, Inc. (Nasdaq:VTUS) will be attending the conferences and is available for one on one meetings.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) will be presenting at JP Morgan's 30th Annual Healthcare Conference on Thursday, January 12, 2012 at 10:00 a.m. PT.

WaferGen Biosystems, Inc. (OTCBB:WGBS.OB) - The company is scheduled to present at OneMedForum on Tuesday, January 10, 2012 beginning at 10:00 a.m. PT.

Tonix Pharmaceuticals Holding Corp. (OTCBB:TNXP.OB), will be presenting at the Biotech Showcase 2012 on Monday, January 9, 2012 at 10:00 a.m. PT, as well as on Tuesday, January 10, 2012 at 10:15 a.m. PT at the OneMedForum Conference.

AtheroNova, (OTCQB: AHRO.OB) will be attending the conferences and is available for one on one meetings.

Fibrocell Science, Inc. (OTCBB:FCSC.OB), will be presenting at the 5^th Annual OneMedForum on Wednesday, January 11, 2012 at 10:00 a.m. PT.

Cerecor Inc. (a privately held company) will present at the Biotech Showcase 2012 on Monday, January 9th at 10:00 AM PST. 

NeoStem, Inc. (NYSE Amex: NBS) will be presenting at Biotech Showcase 2012 on January 10, 2012 at 10:30 a.m. PT.

CytoSorbents Corporation (OTC.BB: CTSO.OB), will present at the OneMedForum 2012 on Wednesday, January 11, 2012 at 11:15a.m. PT.

For more information about each of the conferences, go to:

www.onemedplace.com/forum/

http://www.ebdgroup.com/bts/index.php

About ProActive Capital Resources Group, LLC

ProActive Capital Resources Group, LLC (“PACRG”) (www.proactivecrg.com) is dedicated to the discovery and creation of value in the small-cap marketplace. PACRG provides turnkey solutions that combine traditional investor relations services with the latest Internet, mobile and social media communications. The Company’s integrated digital media and global distribution platform www.ProActiveNewsroom.com connects innovative, emerging-growth companies to the investment community using a variety of user-friendly and interactive formats.

Investor Relations Contact:

Jeff Ramson

Proactive Capital Resources Group, LLC.

212-792-4294

jramson@proactivecrg.com

Athersys (ATHX): New IP that Protects MultiStem (but does not block others) !

Athersys (ATHX) announced earlier in the week a new patent has been granted (U.S. patent 8,075,881) that covers the use of "non-embryonic multipotent stem cells for the treatment of cardiovascular conditions including myocardial infarction, or heart attack, congestive heart failure, myocardial ischemia and other heart conditions".

From the company's press release: "The patent also provides protection for multiple techniques for delivering the stem cells to treat the conditions. Athersys also announced the issuance in 2011 of more than 25 patents in the U.S. and other countries covering non-embryonic multipotent stem cells, their production, and usage.

The issued patents cover Athersys' proprietary MultiStem has demonstrated therapeutic potential to treat a broad range of indications in the cardiovascular, neurological, and inflammatory and immune condition disease areas. Athersys currently has four clinical stage programs in acute myocardial infarction, ulcerative colitis, hematopoietic stem cell transplant support and ischemic stroke using its MultiStem product candidate."

We reviewed the IP claims as many questions were raised about how this IP impacts other companies also pursuing the use of adult stem cells in cardiology, MesoBlast, Cytori, NeoStem, Baxter and we found a few claims that narrow the Athersys IP around a specific cell type where the IP specifies this is for cells that are "mononuclear, centrifuged, and depleted (of CD45 and GlyA). The remaining cells are plated and, with successive doublings in culture, becoming more homogenous - by 10 doublings. So what does this all mean? It means that Athersys has IP to protect MultiStem but this is really not "blocking IP" that locks anyone else out of the space.