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Daily Dose Newsletter

Daily Dose Newsroom is a Daily Dose of Wall Street research and news in the Healthcare, Biotech, and Biomedical sectors.

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Entries in actc (4)

Wednesday
May302012

Hope Springs Eternal In Biotech @ Seeking Alpha (KERX)

Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease. Keryx is developing ZerenexTM (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 ZerenexTM for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is headquartered in New York City. 

At Seeking Alpha, contributor Michael J. Ray writes that while it is true that hope is not the best strategy when it comes to investing, "there is one sector that does embrace hope as an investing component and that sector is speculative biotech." He argues that it is patients' hope for a cure that "highlight[s] unmet medical need, which in turn brings investors and researchers to the scene."

He points to Keryx's Perifosine as an example in which "the hope[s] of both investors and patients were dashed, and the stock price quickly declined." But he goes on to say that,

"Both KERX and BPAX are not completely out the game though. Each has other products in the pipeline, but their most touted opportunities came up empty. But this article is about hope, and hope is said to spring eternal."

He goes on to discuss 3 companies "keeping hope alive" for both patients and investors alike: Osiris Therapeutics (OSIR), Advanced Cell Technology Inc. (ACTC.OB), and Galena Biopharma, Inc. (GALE).

Read the full article at SeekingAlpha.com

Monday
Apr162012

Advanced Cell Technology (ACTC): Second Patient in Dry AMD

Advanced Cell Technology (OTCBB: ACTC) announced that the second patient was dosed in the company’s Phase I/II trial for dry age-related macular degeneration using retinal pigment epithelial cells derived from human embryonic stem cells.

The patient is recovering uneventfully.

See the full press release.

Daily Dose Conclusion: AMD is a big market and dry AMD is an un-met medical need. Should these patients start to have vision improvement the sky's the limit.

Wednesday
Mar142012

Advanced Cell therapy ($ACTC): Reverse Split Ahead: 1:20 and 1:80

Daily Dose Conclusion: Advanced Cell Therapy (OTCBB ACTC): Moving up from OTC BB to NASDQ is always good. This company sports a $200 million market cap and has liquidity so it logical to reverse split the stock. According to the 10K the company ended the year with $13 million and presented at Roth conference this week has a $15 million line they can draw upon.  A quick glance at the filling suggests the company has $21 million in losses last year.  Clinically its early days for ACTC and like every small cap biotech they will be needing funding to keep clinical programs moving forward. We will have to watch for next catalysts.

From the press Release: MARLBOROUGH, Mass. — March 14, 2012 – Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that on Monday, March 12 it filed with the Securities and Exchange Commission a proxy statement containing a shareholder proposal for a reverse split of its common stock.

The annual meeting of stockholders will be held on Thursday, April 26, at the Hyatt Regency Suites, Palm Springs, 285 N. Palm Canyon Dr., Palm Springs, Calif., 92262, on Thursday, April 26, 2012, at 9 a.m. PDT, to consider the following proposals: election of five directors, ratifying the appointment of the company’s public accounting firm, and a proposal to effect a reverse stock split of the company’s common stock, at a ratio between one-for-twenty and one-for-eighty, and to reduce the number of authorized shares of the company’s common stock in the same proportion as the reverse split, with the exact ratio to be determined by the board of directors.

 “This reverse stock split, which should better align the company’s capital structure with its stage of development, and an accompanying Nasdaq listing application, will represent a significant step toward creating long-term shareholder value and building ACT into a world-class player in the regenerative medicine space,” said Gary Rabin, chairman and CEO of ACT. “I hope that our stockholders understand how important it is to vote ‘For’ the reverse stock split. A Nasdaq listing will enable us to significantly broaden our shareholder base and attract institutional ownership, a process that can build on itself to position the company on very firm financial footing over the long term.”

Stockholders who have questions on how to vote or need assistance voting their shares should contact the company’s proxy solicitor InvestorCom, Inc. toll-free at (877) 972-0090.

Macular Degeneration (from the chairmen's Blog): As you are undoubtedly aware, last July we initiated the first-ever clinical trials using a cell therapy derived from human embryonic stem cells (hESCs) to treat various forms of macular degeneration.  The end goal for our clinical trials is to test whether or not the retinal pigment epithelial (RPE) cells we make from hESCs are capable of homing to sites of injury in the retina, replacing the native RPE cells that are lost to disease, and ultimately reestablishing the function of this layer of cells in protecting photoreceptors from cell death, i.e. slowing or halting progressive vision loss.  One of our ongoing trials is for Stargardt’s Macular Dystrophy (SMD, aka Stargardt’s Disease) and the other is for Dry Age-Related Macular Degeneration (Dry AMD).  Last month we also initiated a European clinical trial for Stargardt’s Disease.  That same week, we also published some exciting – albeit very preliminary data – relating to the patients treated last July, in The Lancet.

To date, we have treated one patient with Dry AMD (at UCLA), and a total of four patients with SMD (three at UCLA, and one at Moorfields Eye Hospital in London).  The recent treatment of the two SMD patients at UCLA represents the entire first cohort of patients for this initial dose of cells in the SMD trial.

We are pleased to have both trials underway and delighted with the results we have reported so far.  Clearly, though, the question arises: why does the Stargardt’s Disease trial appear to be moving along at a faster pace than the Dry AMD trial?  This has no doubt been of particular interest to our investors, upon whom the vast size of the potential market for Dry AMD is not lost; a projected market upwards of $25-30 Billion in the US and Europe alone.  I intend to briefly address this issue here.

Thursday
Feb022012

STEM ($STEM): AMD N=16 Trial gets the Green Light from the FDA

Stem Cells, Inc. (NASDAQ: STEM) gets the "green light" from the FDA to kick off a Phase I/II clinical trial of HuCNS-SC in AMD.

The Phase I/II trial will evaluate the safety and preliminary efficacy of HuCNS-SC cells as a treatment for dry AMD. While there are now therapeutic options for wet AMD there is no treatment for dry. The promise of cell therapy in this space is great. Advanced Cell Therapy (ACTC) is also pursuing this indication.

In the case of STEM, the trial will be an open-label, dose-escalation study, approx. N=16. STEM's HuCNS-SC cells will be administered by a single injection into the space beneath the retina. Patients' vision will be evaluated using conventional methods of ophthalmological assessment at predetermined intervals over a one-year period. Patients will then be followed for an additional four years in a separate observational study.

Daily Dose Conclusion: AMD is a promising area as the physical space in the eye is small and the market opportunity is large. The ability to rebuild rods & cones and restore vision is great. Several firms such as ACTC are working in the area. The key question for investors who have been patient with STEM for years and have lived through the most recent raise and reverse stock split: Is there a way back ? With Geron's (GERN) departure STEM is one of the only remaining embryonic (public) company left in the space. STEM is also pursuing the "holy grail" with a spine trial. Certainly the bet here is that STEM hits it big at some point but data is not immediate.

See all $STEM articles @ Daily Dose.