Biotech / Medical | Pharmacyclics (PCYC)


Previous 10 | Next 10 
To: scaram(o)uche who wrote (443)5/17/1999 11:45:00 AM
From: mauser96   of 716
 
More good news. Phase 2 study on Lutrin for metastatic carcinoma of chest wall is in, click on "News".
All of these patients had multiple chemotherapy failures and most had radiation failures, so they represented a very hard to treat group.
Reading between the lines, it seems to me that Lutrin is an easier treatment to do than most, side effects are limited to the area treated rather than whole body, and therefore this could become the first treatment tried ,rather than the last. Also, though it wasn't tested, it might work best with minimal side effects if given as a set of smaller dose treatments rather than one big one. This phase 2 study has determined the optimum time relationship between giving the Lutrin, and the light, so future studies should show even better results. This form of breast cancer isn't that common, so the potential market is limited.

Share Recommend | Keep | Reply | Mark as Last Read | Read Replies (1)

To: mauser96 who wrote (444)5/19/1999 12:07:00 PM
From: tnsaf   of 716
 
Some time ago there was mention of a company using radiation to prevent restenosis after angioplasty by killing smooth muscle cells that proliferate to clog the artery. Page 20 of the May 8 issue of New Scientist has a short article on a drug, 5-amino laevulinic acid, that sensitizes tissues to breakdown by laser and accomplishes the same end. This treatment has been used used by a team at the National Medical Laser Centre at University College London to treat patients, with arteries remaining clear six months later in all treated patients.

Jason

Share Recommend | Keep | Reply | Mark as Last Read | Read Replies (2)

To: tnsaf who wrote (445)5/19/1999 12:51:00 PM
From: scaram(o)uche   of 716
 
thanks, thanks, thanks..... here's some background on the group. Don't have time right now to see if this is the most relevant reference available........

Br J Cancer 1998 Nov;78(10):1278-82

Enhancement of 5-aminolaevulinic acid-induced photodynamic therapy in
normal rat colon using hydroxypyridinone iron-chelating agents.

Curnow A, McIlroy BW, Postle-Hacon MJ, Porter JB, MacRobert AJ, Bown SG

National Medical Laser Centre, Institute of Surgical Studies, University College London Medical School, UK.

Currently, the clinical use of 5-aminolaevulinic acid (ALA)-induced protoporphyrin IX (PPIX) for photodynamic therapy
(PDT) is limited by the maximum tolerated oral ALA dose (60 mg kg(-1)). This study investigates whether hydroxypyridinone
iron-chelating agents can be used to enhance the tissue levels of PPIX, without increasing the administered dose of ALA.
Quantitative charge-coupled device (CCD) fluorescence microscopy was employed to study PPIX fluorescence
pharmacokinetics in the colon of normal Wistar rats. The iron chelator, CP94, when administered with ALA was found to
produce double the PPIX fluorescence in the colonic mucosa, compared with the same dose of ALA given alone and to be
more effective than the other iron chelator studied, CP20. Microspectrofluorimetric studies demonstrated that PPIX was the
predominant porphyrin species present. PDT studies conducted on the colonic mucosa showed that the simultaneous
administration of 100 mg kg(-1) CP94 i.v. and 50 mg kg(-1) ALA i.v. produced an area of necrosis three times larger than
similar parameters without the iron-chelating agent with the same light dose. It is possible, therefore, to increase the amount of
necrosis produced by ALA-induced PDT substantially, without increasing the administered dose of ALA, through the
simultaneous administration of the iron-chelating agent, CP94.

Share Recommend | Keep | Reply | Mark as Last Read

To: tnsaf who wrote (445)5/19/1999 12:51:00 PM
From: scaram(o)uche   of 716
 
thanks, thanks, thanks..... here's some background on the group. Don't have time right now to see if this is the most relevant reference available........

Br J Cancer 1998 Nov;78(10):1278-82

Enhancement of 5-aminolaevulinic acid-induced photodynamic therapy in
normal rat colon using hydroxypyridinone iron-chelating agents.

Curnow A, McIlroy BW, Postle-Hacon MJ, Porter JB, MacRobert AJ, Bown SG

National Medical Laser Centre, Institute of Surgical Studies, University College London Medical School, UK.

Currently, the clinical use of 5-aminolaevulinic acid (ALA)-induced protoporphyrin IX (PPIX) for photodynamic therapy
(PDT) is limited by the maximum tolerated oral ALA dose (60 mg kg(-1)). This study investigates whether hydroxypyridinone
iron-chelating agents can be used to enhance the tissue levels of PPIX, without increasing the administered dose of ALA.
Quantitative charge-coupled device (CCD) fluorescence microscopy was employed to study PPIX fluorescence
pharmacokinetics in the colon of normal Wistar rats. The iron chelator, CP94, when administered with ALA was found to
produce double the PPIX fluorescence in the colonic mucosa, compared with the same dose of ALA given alone and to be
more effective than the other iron chelator studied, CP20. Microspectrofluorimetric studies demonstrated that PPIX was the
predominant porphyrin species present. PDT studies conducted on the colonic mucosa showed that the simultaneous
administration of 100 mg kg(-1) CP94 i.v. and 50 mg kg(-1) ALA i.v. produced an area of necrosis three times larger than
similar parameters without the iron-chelating agent with the same light dose. It is possible, therefore, to increase the amount of
necrosis produced by ALA-induced PDT substantially, without increasing the administered dose of ALA, through the
simultaneous administration of the iron-chelating agent, CP94.

Share Recommend | Keep | Reply | Mark as Last Read | Read Replies (1)

To: tnsaf who wrote (445)5/19/1999 2:35:00 PM
From: John Metcalf   of 716
 
5-aminolaevulinic acid is the PDT agent used by DUSA for actinic keratoses. It has no patent protection and is readily available (listed in the Sigma catalog). Lack of patent protection would tend to lessen the odds of development by a pharma or biotech.

Thanks for the information. This is the first mention I've seen of ALA being used in a coronary application.

Share Recommend | Keep | Reply | Mark as Last Read | Read Replies (1)

To: John Metcalf who wrote (448)5/20/1999 9:20:00 AM
From: ouija   of 716
 
Wrong on patent protection. DUSA has an exclusive use patent on ALA covering the US, Japan, and elsewhere. It does not cover Europe. Any use for treatment of any type is covered by the patent.

ALA is aimed at multiple billion dollar markets. Approvable letter due from the FDA by July 1, panel scheduled for June 3, 90% efficacy rate for AK but off label much larger.

Share Recommend | Keep | Reply | Mark as Last Read | Read Replies (1)

To: ouija who wrote (449)5/20/1999 9:52:00 AM
From: Biomaven   of 716
 
DUSA has an exclusive use patent on ALA covering the US, Japan, and elsewhere. It does not cover Europe. Any use for treatment of any type is covered by the patent.

Here is the relevant section from the DUSA 10-K:

All United States patents and patent applications licensed from PARTEQ
relating to ALA are method of treatment patents. Method of treatment patents
limit direct infringement to users of the

methods of treatment covered by the patents. The Company currently has patents
and/or pending patent applications in the United States and in a number of
foreign countries covering unique physical forms of ALA, compositions containing
ALA, as well as ALA applicators, light sources for use with ALA, and other
technology. The Company can give no assurance that any pending patent
applications will mature into issued patents.

Even with the issuance of additional patents, other parties are free to
develop other uses of ALA, including medical uses, and to market ALA for such
uses, assuming that they have obtained appropriate regulatory marketing
approval. Certain forms of ALA are commercially available chemical products. ALA
in the form commercially supplied for decades is not itself subject to patent
protection. Subject to any other protection that may be available to the Company
regarding its proprietary technology, any third-party is free to use ALA in the
form now commercially available for any indication not covered by the Company's
patents, assuming that such third-party has obtained appropriate approval. In
fact there are reports of several third-parties conducting clinical studies with
ALA for the treatment of certain conditions in countries outside the United
States of America where PARTEQ may not have patent protection.


DUSA might well get some Waxman-Hatch protection, though.

Peter

Share Recommend | Keep | Reply | Mark as Last Read | Read Replies (1)

To: Biomaven who wrote (450)5/20/1999 9:59:00 AM
From: ouija   of 716
 
It appears pretty clear to me. PARTEQ (Queens University) has the use patents tied up in the US and some other countries, but not all. In the countries not covered, other people can develop ALA products. But DUSA has exclusive control in this country (plus) under PARTEQ's use patents. Also, DUSA has patents on their specific approach. Since this is a device/drug combination, once the original patent runs out, DUSA still has generics blocked unless they go the same trial path which DUSA followed, a large barrier to entry not available with just drugs.

What does Waxman-Hutch refer to?

Share Recommend | Keep | Reply | Mark as Last Read | Read Replies (1)

To: ouija who wrote (451)5/20/1999 10:07:00 AM
From: Biomaven   of 716
 
Waxman-Hatch is the law regulating the introduction of generics. It also can extend patent terms up to 5 years to compensate for the time spent getting approved, and sometimes gives you a period of exclusivity even if there is no patent.

Peter

Share Recommend | Keep | Reply | Mark as Last Read | Read Replies (2)

To: Biomaven who wrote (452)5/20/1999 10:17:00 AM
From: ouija   of 716
 
well, maybe that is where the rule-of-4 I am talking about comes from...nobody can copy DUSA's work even after the patents run out without a total of 4 entities first going through all the trials with their specific drug-device combination. It creates a great barrier to entry. Almost makes me want to focus on drug-device companies exclusively.

Share Recommend | Keep | Reply | Mark as Last Read
Previous 10 | Next 10 

Copyright © 1995-2013 Knight Sac Media. All rights reserved.