RGS 0.00% 12.0¢ regeneus ltd

Check out the ABC 7.30 report re RGS 6th Oct, page-2

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    Thanks TheGardener, here is the transcript and I must agree damn it.

    Looks like another dud investment by moi. Hopefully its a storm in a tea cup and I wonder if that is why RGS dropped 6c before partial recovery on Friday last. If not it could be ugly tomorrow.

    http://www.abc.net.au/news/2014-10-06/biotech-company-under-fire-over-afl-approval-claim/5794026
    Biotech company Regeneus under fire for saying AFL approved stem cell treatment, claims made to patients

    7.30
    By Louise Milligan
    Posted 44 minutes agoMon 6 Oct 2014, 8:27pm
    VIDEO: Questions raised over stem cells treatment claims (7.30)
    PHOTO: Stem cells (ABC)
    MAP: Australia
    A listed company offering stem cell treatments to injured athletes is under fire for talking up the AFL's "approval" of its procedure and allegedly misleading the stock exchange.
    In August, Sydney-based biotech company Regeneus, which raised $12 million by listing on the stock market last year, put out a press release headed "ASX Announcement" which said the AFL "approved" the use of its liposuction-based stem cell procedure for injured players.
    But the ABC's 7.30 program has obtained a letter of complaint written by a group of Australia's leading stem cell scientists, alleging the company withheld information about its procedure's efficacy in a price-sensitive announcement to the market.
    Sports physician and stem cell researcher Dr Mark Young is concerned about Regeneus' claims.
    "I think we're all concerned that patients are being given treatments where there's no evidence of benefit and they're paying an awful lot of money for it," he told 7.30.
    It is misleading because the control (placebo) group in that trial also achieved the same reduction in pain and slowing of cartilage degeneration
    Letter of complaint from stem cell scientists

    Regeneus has had much fanfare for its product, which costs $10,000 per treatment.
    Its announcement said an independent clinical trial had demonstrated the procedure "reduces pain and halts cartilage degeneration in arthritic joints".
    However, the complaint letter obtained by 7.30 points out the statement left out some key information.
    "It is misleading because the control (placebo) group in that trial also achieved the same reduction in pain and slowing of cartilage degeneration," the letter said.
    The control group simply had saline injected into their knees.
    Orthopaedic surgeon Dr Justin Roe works at the same clinic as the researchers who conducted the study for Regeneus.
    "To not have stem cells harvested and to have something saline put in the joint was just as good as having the stem cells harvested," Dr Roe said.
    "So, in a scientific, evidence-based term, there was no difference between the two."
    Treatment considered safe, allowed by WADA code: Regeneus

    Martin Pera, who is Professor of Stem Cell Biology at the University of Melbourne and runs the Australian Research Council's special initiative on stem cells, applauds Regeneus for funding a proper clinical trial, but wonders why the company cherry-picked the evidence in its statement to the ASX.
    "The answer is not to take scientific short cuts in the evaluation of safety and advocacy," Professor Pera said.
    "The answer is not to mislead the public about outcomes of these therapies. The fact is that this procedure didn't work - it was never going to work - it's not based on good clinical evidence unfortunately Dr Justin Roe

    "They are pathways that will be bad for the field and ultimately bad for companies that are trying pioneer these new therapies."
    The complaint letter alleges the misleading statement was a breach of Principle 5 of the ASC Corporate Governance Principles, which requires that listed companies do not "omit material information" and that announcements should be "expressed in a clear and objective manner that allows investors to assess the impact of the information when making investment decisions".
    Ben Herbert, who is co-founder of Regeneus, was not aware of the complaint before being told by 7.30.
    "This statement to do with the AFL was really to say that the AFL were saying that on a case-by-case basis, cell therapy HiQCell from Regeneus could be used to treat players, they considered it was safe, and it doesn't infringe the WADA code," Associate Professor Herbert told 7.30.
    When asked why Regeneus did not state the placebo group had achieved the same results in the press release, Associate Professor Herbert said: "There's many statements on the record by Regeneus to do with placebo and pain reduction and, like I say, pain reduction on its own is not really the only story here."
    "What doctors who treat patients are interested in is can you do something in the joint to change the course of the disease?"
    Regeneus had put out a press release almost a year earlier which explained the treatment and placebo groups had the same results.
    The company points out that its clinical trial showed some promising improvement inside the joints of the patients who had the stem cells, in what are known as "bio-markers".
    But Professor Pera wonders whether this is worth the $10,000 cost for a Regeneus treatment.
    "Precisely what those measurements mean in terms of long-term outcomes for the patients is unclear," he said.
    "I'd say that the bulk of the clinical evidence show there was no difference (between the treated group and the placebo)."
    Procedure 'not based on good clinical evidence', surgeon says

    7.30 has also learned the AFL was displeased when Regeneus put out the press release because it felt was dressed up to look like an official AFL endorsement.
    In fact, it was based on one discussion with the AFL chief medical officer about one player from one club.
    Sydney retiree, Hilary Richards, had to have a full knee replacement three months ago after waiting in vain for a year for a Regeneus procedure to work

    She says the doctor who performed the stem cell injection told her she would be able to walk out, pain-free, after the procedure.
    "I did walk out, but it was excruciatingly painful," said Ms Richards, who added that she "didn't want to appear stupid" for paying the $10,000 for the procedure.
    Dr Justin Roe was the orthopaedic surgeon who did Ms Richards' knee replacement when the stem cell procedure failed.
    "She was a lady who had well-established osteoarthritis, having pain, loss of function and stiffness, which were evident prior to the procedure and then remained after the procedure," Dr Roe said.
    Dr Roe said he is seeing three or four patients a month who have had failed Regeneus procedures.
    "Hilary was harmed not only financially but mentally and emotionally," he said.
    "The fact is that this procedure didn't work, it was never going to work, it's not based on good clinical evidence unfortunately."
    Dr Young believes stem cell companies are using footballers as a marketing push to reach the real osteoarthritis market: older patients like Ms Richards.
    "I'm sure that athletes are being exploited," Dr Young said.
    "Athletes are vulnerable people - they want to get better as quickly as possible.
    "They're desperate, they're well cashed up and they're high-profile."
 
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