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HPT/Axis, Inc. Awarded “Most Promising Life Science Technology Company” at 2010 Rice Alliance Life Science Venture Forum

This company is seeking to get approval of a drug protocol that will speed up the normalization of the Hypothalamus-Pituitary-Gonadal  (HPG) Axis after long term use of anabolic steroids or testosterone for medical or non medical uses.  Cessation of anabolics or testosterone replacement causes androgen -induced hypogonadism that can negatively impact someone's health if the HPG axis does not stabilize soon after these compounds are stopped.  Depression, fatigue, sexual dysfunction, lack of motivation, and other health related problems can occur.

FOR IMMEDIATE RELEASE
 June 24, 2010 -- 
HOUSTON – HPT/Axis, Inc. was named one of the most promising Life Science companies at the 9th Annual Rice Alliance for Technology &Entrepreneurship Life Science Venture Forum in Houston last week. Life Science companies showcased their new ventures for an audience of more than 400 attendees, including investors, venture capitalists, industry representatives, business leaders, advisors/mentors, service providers, and entrepreneurs. 

Cynthia A. Doerr, M.D., partner, Essex Woodlands Health Ventures said of the presenters, “This is one of the most mature groups of healthcare-related company presentations that I have reviewed in Houston, and I intend to follow their progress closely.” 

HPT/Axis, Inc., a Delaware C Corporation, seeks to profit from developing a treatment for the adverse effects that occur from the condition androgen-induced hypogonadism (AIH), a condition that occurs 100% of the time after stopping androgen or anabolic steroid use, both prescription and nonprescription, the only variables being the duration and severity. The effects of AIH include decreased sex drive,impotence, infertility, depression, obesity, decreased muscle strength and mass, cognitive impairment, and more. 

The Federal and State government have taken special notice for the period after androgen cessation. In 2005, the U.S. House of Representatives held a committee hearing, "Restoring Faith in America’s Pastime: Evaluating Major League Baseball’s Efforts to Eradicate Steroid Use," that took special notice of the adverse effects after stopping anabolic steroids, particularly depression and suicide. The Committee received testimony from several parents whose sons had committed suicide after stopping androgen use. Testimony from Kirk J. Brower, M.D., University of Michigan, stated, "[d]epressive episodes and suicide attempts are most likely to occur within three months of stopping [androgen] use." In that same year, Texas HB 3563, "Use Of Anabolic Steroids By Public School Students", was passed and signed into law. Of particular importance is the bill’s analysis citing the problem of "clinical depression when steroid use is stopped." 

HPT/Axis’ drug candidate will be first-in-class, the standard of care treatment. Our treatments have intellectual property protection by pending novel method-of-use patents. HPT/Axis’ lead drug candidate, enclomiphene, is a repositioning of the current FDA approved generic drug clomiphene. Repositioning allows for an expedited path to FDA approval. The company recently completed a successful FDA pre-IND meeting, which gave a preliminary approval for the initiation of clinical trials. 

Michael Scally (mscally@hptaxis.com), HPT/Axis' President & CEO, stated, "Combining the number of men who stop using anabolic steroids, both prescription and nonprescription, there is a substantial current market for this indication, increasing by double-digits annually. We believe HPT/Axis is on a timeline for a FDA NDA within three to five years." 

The one-day event culminated in an announcement of the Most Promising Life Science Companies chosen from nearly 40 competitors and judged by the Rice Alliance Information Technology Advisory Board, based on the companies’ elevator pitch presentations. The exercise simulates meeting an investor on an elevator and having only 90 seconds to convince them to invest in your company. 

Rice Alliance Director Brad Burke, announced the winners of the Most Promising Life Science Company awards at the event. “Every year the quality of companies improves. Many of the companies at this year’s event have developed prototypes, obtained proven results and are on their second round of funding. This makes them more appealing to investors, who have also expressed appreciation for the quality of the companies.” 

The Forum was supported by Baker Botts, LLP, Essex Woodlands Health Ventures, Winstead Attorneys and Santé Venture with supporting sponsors Greater Houston Partnership and Houston Technology Center and media sponsors Houston Business Journal and the BusinessMakers Radio Show. Elevator pitches from the competition can be seen at www.alliance.rice.edu beginning July 6, 2010

World AIDS Day: Adverse Impact of Steroid Law and Steroid Hearings on Anabolic Therapies

World AIDS Day: Adverse Impact of Steroid Law and Steroid Hearings on Anabolic Therapies
Posted on 15:42 December 1st, 2008 by Millard Baker

http://www.mesomorphosis.com/blog/2008/12/01/world-aids-day-adverse-impact-of-steroid-law-for-hiv/

In recognition of World AIDS Day, we urge Congressional leaders in the United States to carefully consider the significant harm that morally-guided U.S. steroid policy has had for the life-saving therapeutic applications offered by anabolic-androgenic steroids. The criminalization of anabolic steroids and steroid hysteria perpetuated by Congressional steroid hearings has had an adverse impact on medical research and medical therapies involving anabolic steroids, particularly in the prevention and treatment of HIV+ associated wasting disease.

Anabolic steroids are one of the safest and most effective treatments for HIV associated wasting and have been invaluable in helping HIV+ patients retain, preserve and restore lean body weight and stay alive. Given that wasting is one of the most common symptoms of HIV and that HIV+ patients with wasting symptoms have significantly higher mortality rates, anabolic steroids have been an invaluable medical treatment.

Michael Mooney, of Medibolics, and Nelson Vergel, of the Program for Wellness Restoration, have spearheaded educational efforts and have extensively documented the benefits of anabolic steroid therapy for AID/HIV wasting in “Built to Survive“. Mooney and Vergel have discussed the negative consequences arising from the demonization of steroids by the Anabolic Steroid Control Act of 1990 (”Anabolic Steroid Legality and the Physician,” January 28).

The Anabolic Steroid Act of 1990 created grave misunderstandings about the legal status of “steroids as medicines” to the public and to the physicians trying to help their patients. This law states only that anabolic steroids can not be prescribed for cosmetic or athletic purposes, but the impression it created was that steroids were off limits to everyone, and that they are basically illegal for any use. This is not the case. To compound this climate of fear, it seems that when this law was passed in 1990 several of the more conservative regional governing medical organizations made doctors uneasy, giving them impression that they would become the object of scrutiny if they prescribed steroids at all.

The scheduling of anabolic steroids as controlled substances was a medical catastrophe that pandered to anti-doping crusaders in sports while ignoring the medicinal value of androgens and the life-saving therapeutic potential this category of pharmaceutical drugs offered for HIV+ patients. The regulatory agencies in charge of scheduling of drugs strongly protested the inclusion of anabolic steroids in the Controlled Substances List. Legislators ignored the scientific advisors and experts from the American Medical Association (AMA), the Food and Drug Administration (FDA), the Department of Health and Human Services (DHHS) and the Drug Enforcement Enforcement (DEA) to pass the Anti-Drug Abuse Act of 1988 and the Anabolic Steroid Control Act of 1990.

The legislators were guided by the moral condemnation of athletes that use anabolic steroids and performance enhancing drugs rather than a rational empirical analysis of steroid use and abuse and the effects of such legislation on leigitmate medical research and anabolic therapy.

Unfortunately, the steroid hysteria has continued with the Congressional steroids and baseball hearings initiated by Henry Waxman (and former chief of staff Phil Schiliro) and the passage of more draconian steroid laws in recent years. California resident Mark A. Meier outlined the impact the steroid hearings in a letter to the Nancy Pelosi, Speaker of the House (”Representative Henry Waxman’s Hearings on Steroids in Sports and the Impact on Treatments for HIV and other Medical Conditions,” March 12).

The result, then, of Representative Waxman’s hearings has been an attack on an important, powerful, beneficial and legal therapy solely because professional athletes use it improperly. Patients with legitimate medical needs should not be made to suffer because of the improper actions of a few.

Nelson Vergel of the HIV Blog explains how political pressure and steroid hysteria have restricted the availability of anabolic steroids for HIV+ patients. The moral and political pressure resulted in the discontinuation of Deca Durabolin by Watson Pharmaceutical and the discontinuation of nandrolone decanoate by compounding pharmacies like Applied Pharmacy (”Important information about nandrolone in the U.S.” March 17).

Watson stopped making [nandrolone decanoate] because… Congress and the DEA are treating anabolics like the treat crack-cocaine and are closely watching every prescriber’s and manufacturer’s move. No HIV doc has ever got in trouble since many studies have shown nandrolone’s benefit and can justify its medical use. However, inexperienced HIV doctors who have not been around long enough to know its history shy away from prescribing due to the bad publicity and misconceptions around these medicines. [...]

Applied Pharmacy stopped all production due to DEA pressure. Some compounders are making doctors sign a waiver to say they will not prescribe nandrolone for non medical uses. Some doctors feel this represents extra liability.

The effects of anabolic steroids in treating HIV+ associated wasting syndrome by preserving and increasing lean body weight has been well documented by multiple studies. Unfortunately, Congressional leaders in the United States have based steroid policy on emotional testimony and moral objections to cheating in sports rather than scientifically-guided legislative policy; this has been to the detriment of individuals with AIDS/HIV+ associated wasting syndrome. The morally-guided steroid policy has effectively limited the availability of anabolic steroids for those individuals who use steroids as a matter of medical necessity. We urge Congress to reconsider and re-evaluate the Anabolic Steroid Control Act to address the address the adverse effects of current steroid policy on the advancement of anabolic therapies in medicine.