June 21, 2013 Naked Mole Rats Point to Obscene Bi

June 21, 2013

Naked Mole Rats Point to Obscene BioTime Profits

Dear Breakthrough Technology Alert Reader,

After writing this week's alert about the benefit to BioTime (AMEX: BTX) from the Supreme Court gene ruling, another story broke with profound implications for the company. You may, in fact, have seen one of the many stories written about the University of Rochester discovery regarding the extremely long life spans of Heterocephalus glaber, aka the naked mole rat. Dozens of publications carried the story involving this unlikely creature.

Author: Roman Klementschitz, Wien

Naked mole rats have been the object of scientific curiosity since these East African rodents were discovered by Western researchers. Though notably grotesque, these animals exhibit one very attractive attribute. They live far, far longer than almost all other members of the order Rodentia. Most mice and rats live only a few years, many dying naturally of cancer. Naked mole rats, however, can live for 10 times that, nearly 30 years, and cancer is all but unknown in the species.

The BioTime OrthoCyte Connection

I've previously written at length about BioTime subsidiary OrthoCyte. As the name implies, this subsidiary was founded to tackle orthopedic or musculoskeletal stem cell applications. BioTime's ACTCellerate cell development platform is unique in that it has produced a spectrum of connective-tissue stem cells. This is in contrast to the adult stem cell companies that seem able to create only bone tissues, even when attempting cartilage. BioTime has created stem cells that produce the full range of connective tissues and cartilage necessary for joint function.

From the beginning, BioTime scientists knew that their cells alone were not sufficient to effectively repair tendons, cartilage, bone and other connective tissue on their own. Even if the perfect cells are injected into the site of an orthopedic injury, they quickly dissipate. A layer of cells may engraft and remain in place, but orthopedic parts are not one layer thick. They're 3-D and often quite large.

For this reason, BioTime executives engaged in a search for a delivery mechanism that would duplicate the natural extracellular matrix (ECM), the scaffolding within which living cells function. At the heart of the search was Arnold I. Caplan, Ph.D., OrthoCyte's chief scientific officer. Caplan, as you know, is frequently referred to as the "father of adult stem cell medicine." He founded Osiris Therapeutics and a number of other important orthopedic companies. His "conversion" to the pluripotent stem cell side was an important indicator of the superiority of BioTime's platform in the area of tissue repair.

Though BioTime had the cells needed for orthopedic and other tissue repair, some material was needed to properly deliver stem cells en masse. The standards were high, and none of the materials on the market filled the bill. The material they sought would have to be moldable so that cells would develop in complex configurations that could be modified for individual patients. It couldn't provoke an inflammatory response and, ideally, would be replaced by the body's own scaffolding materials as it wore out.

About 2½ years ago, BioTime acquired Utah-based Glycosan BioSystems. The president and CEO of that company, William P. Tew, Ph.D., became vice president of business development at OrthoCyte Corp. Tew has been interviewed in this publication.

Prior to founding Glycosan BioSystems, Tew was associate provost of The Johns Hopkins University. There, he led the consolidation and reorganization of the university's technology licensing offices and designed the university's first comprehensive IP management and technology licensing policies and procedures. This experience is reflected in his current approach to developing collaborations. He also has significant experience developing and manufacturing bulk pharmaceuticals, parenteral drugs and medical devices in compliance with FDA and government-mandated cGMP (current good manufacturing practice) regulations.

The technology that Tew brought to BioTime is a suite of products now known as HyStem hydrogels. These materials do everything that I described above and more. Moreover, they are made of naturally occurring materials found in the body's own extracellular matrix. Moreover, they have been modified so that they can be delivered using a simple hypodermic as a liquid that will firm up into the needed shape. They can be filled with stem cells that prosper in these materials, though they can also deliver drugs for very controlled time release.

The Marvel of Wonder Goo

Foremost among the natural materials found in the HyStem product line is a complex carbohydrate polymer known as high-molecular-mass hyaluronan (HMM-HA). In the body, our own HA plays numerous critical structural and signaling roles. It is a crucial part of cartilage, the skin and many other organs. HA is critical for wound healing and, because it is so hydrophilic, or water-attracting, it lubricates the body. It plays a critical role in embryogenesis, and the umbilical cord consists primarily of HA. When we are young, we have plenty of high-molecular-mass HA. As we age, we produce more HA, but its molecular weight falls, which explains why our skin and joints lose elasticity.

At one time, this amazingly dense substance was called "wonder goo" and was famous for clogging the drains of labs studying it. For an overview of HA, read the Wikipedia entry, but keep in mind that the linked article has not yet been updated to include the information discovered by the University of Rochester researchers.

Specifically, Andrei Seluanov and Vera Gorbunova found that the longevity of naked mole rats depends on their rich, cancer-fighting deposits of high-molecular-mass HA. They have so much HMM-HA, in fact, that the ScienceDaily article reports it came to the scientists' attention because it was "clogging the vacuum pumps and tubing."

I won't go over their entire experiment but will point out that mole rats that had HA production blocked quickly got cancers and died. The researchers believe that HMM-HA activates the cancer-killing p16 gene. By all means, read at least the overview of the Nature study, here.

The entire study is worth reading, however.

BioTime Has the Only Useful Form of Living Wonder Goo

From the perspective of an investor, however, the important thing to know is that BioTime has the only usable HMM-HA available. You should watch the June 4, 2014, video, here.

In this discussion with Michael West and William Tew, Tew notes that the company is already collaborating with cancer researchers who are using HyStem. It goes without saying that any researchers who develop products using HyStem will need to license and share profits with BioTime.

In fact, at least 30 researchers are using HyStem in therapies aimed at the repair of the heart, liver, kidney, vocal cords, brain and more. Using HyStem for controlled release of growth factors in animal brains, scientists have seen the first successful repair of damaged brain tissues following a stroke.

The HyStem technology was always a big deal. The University of Rochester discovery, however, makes it enormous. I believe, due to the thoroughness of the study combined with our previous knowledge about HMM-HA, HyStem will be proven to be a powerful anti-cancer technology. I envision a time when it is easily applied to skin cancers and at the site of virtually all cancer surgeries to prevent metastasis and spreading.

I should remind you, as well, that HyStem appears to be the next generation of reconstructive surgery. Besides being used for joint reconstruction, it should replace breast implants. HyStem and a patient's own stem cells could be used to create living implants that would eventually be replaced by entirely natural tissues. For patients like Angelina Jolie, who opted to have a double mastectomy after discovering she has the gene mutation for breast cancer, this would be a perfect solution.

I seriously recommend that you watch at least the short William Tew video linked above. For those who are unafraid of medical and scientific terminologies, please watch the two Glenn Prestwich videos about HA found on this page.

Oh, I almost forgot. HyStem is already in broad use within the unregulated veterinary community for wound healing and such. This is one reason that we can have so much confidence that the technology will perform in humans.

One of the major benefits of using HyStem in animals is that it is naturally anti-inflammatory. It prevents scarring and fibrosis at the site of injury. It is used to treat injuries in top race horses, keeping them capable of running following tendon and other injuries. It not only promotes bone and tendon healing, but keeps healed connective tissue flexible and free of scar tissue. Frequently, by the way, animals are getting better care than humans, due to the lack of FDA involvement. The Glenn Prestwich videos have more information, including pictures, of animal uses.

Yours for transformational profits,

Patrick Cox