And the 2009 IPO class grows with the announced filing of Durham, NC-based Aldagen. The post title is a poor attempt at a double entendre – the Company had previously filed their S-1 for a planned public offering approximately 12 months ago (updated filing is [HERE]), and their business model focuses on regenerative cell therapies, so there you have it, my attempt at life science humor.

Getting down to the details. The Aldagen technology is focused upon a potentially novel approach to isolating adult stem cells for therapy via the identification, selection and isolation of adult stem cells that express high levels of the enzyme ALDH. The ALDH enzyme plays an important role in controlling the developmental state of stem and progenitor cells by converting Vitamin A into retinoic acids, which are molecules that regulate genes and influence the differentiation of blood, neural, endothelial and other types of stem and progenitor cells. To identify ALDH cells a proprietary chemical compound is used that accumulates in cells with high ALDH levels and causes these cells to emit a green florescence that can be detected by a cell sorting device. The ALDH stem cell populations produced using the Aldagen technology are believed to have several potential advantages, including: A heterogeneous mix of stem cells and progenitor cells. The ALDH cell populations contain a heterogeneous mix of stem cells and progenitor cells, potentially including hematopoietic, mesenchymal and neural stem cells and endothelial progenitor cells. Other companies are pursuing stem cell therapeutic approaches to tissue repair that consist of homogeneous cell populations containing only one of these types of cells. Because of the diversity of the stem cell types included in the ALDH cell populations, this may promote repair in a variety of ways. Based on preclinical research, ALDH cell populations promote the formation of new tissue either because progenitor cells present in ALDH cell populations themselves differentiate into new tissue, or because ALDH cells induce the generation of new tissue from existing tissue or from other progenitor cells within the patient. Other potential advantages include:

• broad potential applicability promoting the regeneration of multiple types of cells and tissues and a variety of therapeutic uses
• well characterized stem cell lines having a high level of purity and a consistent set of physical and chemical characteristics, and
• a rapid manufacturing process

Aldagen is currently conducting a pivotal Phase III clinical trial of ALD-101 for improving umbilical cord blood transplants used to treat inherited metabolic diseases in pediatric patients. ALD-101 is the population of ALDH stem cells produced from a portion of a cord blood unit which is infused into a patient shortly after the transplant of the remaining portion of the cord blood. In a Phase I clinical trial a reduction in the time to platelet and neutrophil engraftment in patients receiving ALD-101 following their cord blood transplant, as compared to similar patients who had received a cord blood transplant without ALD-101 in an earlier independent clinical trial was observed. The reduction in engraftment time may reduce risks associated with cord blood transplants and decrease the length and cost of the related hospital stay. In March 2008 a pivotal Phase III trial of ALD-101 was initiated to further evaluate its ability to accelerate engraftment following cord blood transplants in pediatric patients with inherited metabolic diseases. Enrollment completion of this trial is expected in the 1Q11 efficacy results of the trial are expected in 2Q11. ALD-101 has received orphan drug designation from the FDA for improving engraftment times in patients with inherited metabolic diseases undergoing cord blood transplants.

Earlier clinical programs include ALD-301 to treat critical limb ischemia and ALD-201 to treat ischemic heart. Aldagen is planning to raise capital somewhere in the ballpark of $80M with the help of Cowen and Co. (NASDAQ: COWN) and Wells Fargo Securities (NYSE: WFC). Considering Aldagen is a best perhaps 20 months or so away from filing their NDA for ALD-101, with the acknowledgment of potential accelerated approval from FDA as a result of receipt of ALD-101 receiving orphan drug designation – the public markets appear to be demanding entities that are perhaps potentially closer to commercialization, therefore it will be very interesting to observe the reaction to the Aldagen issue from when initially floated to their first earnings call post approval.

Hang on for what is certain to be an interesting ride – and naturally it goes without saying but reckon will indeed say, do not consider any of these ramblings appearing anywhere on this blog, to be investment or any other type of regulated advice.